Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-03-03 @ 3:53 PM
Study NCT ID:
NCT01801358
Status:
TERMINATED
Last Update Posted:
2020-09-16
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'Italy', 'Norway']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098943', 'term': 'Uveal Melanoma'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543528', 'term': 'sotrastaurin'}, {'id': 'C581313', 'term': 'binimetinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@arraybiopharma.com', 'phone': '303-381-6604', 'title': 'Study Director', 'organization': 'Array BioPharma, Inc.'}, 'certainAgreement': {'otherDetails': "The terms and conditions of the sponsor's agreements with its investigators may vary. However, the sponsor does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e. data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.', 'description': 'AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'TUMOUR PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'BLOOD CREATINE PHOSPHOKINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'EJECTION FRACTION DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'LYMPHOCYTE COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'BLOOD LACTATE DEHYDROGENASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'CEREBROVASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'PRESYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 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'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'HEPATOMEGALY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'HYPOTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'ESCHERICHIA BACTERAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (DDS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (DDS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (DDS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (DDS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'title': 'Anaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'General Physical Health Deterioration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Blood Creatinine Increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Ejection Fraction Decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Dermatitis Acneiform', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 (up to 28 days)', 'description': 'A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.', 'unitOfMeasure': 'DLTs', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is comprised of the Dose-determining Set, which is all patients from the safety set who either met the minimum exposure criterion below and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1.'}, {'type': 'PRIMARY', 'title': 'Phase II: Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II (Dose Expansion)', 'description': 'Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.'}], 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': 'The time from date of randomization to the date of event defined as the first documented progression or death due to any cause.\n\nDue to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG006', 'title': 'Phase II (Dose Expansion)', 'description': 'Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': "An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group consists of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG006', 'title': 'Phase II (Dose Expansion)', 'description': 'Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': "Serious adverse event (SAE) is defined as one of the following:\n\n* Is fatal or life-threatening\n* Results in persistent or significant disability/incapacity\n* Constitutes a congenital anomaly/birth defect\n* Is medically significant\n* Requires inpatient hospitalization or prolongation of existing hospitalization\n* Note that hospitalizations for the following reasons should not be reported as serious adverse events:\n\n * Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition\n * Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent\n * Social reasons and respite care in the absence of any deterioration in the patient's general condition", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 (up to 28 days)', 'description': "Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.\n\nThe best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib (Dose Escalation)', 'description': 'For Phase Ib, a minimum of three patients will be entered into each cohort and evaluated for safety (DLTs and any other medically significant event) at the end of Cycle 1.\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'timeFrame': 'Cycle 1 (up to 28 days)', 'description': 'Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.\n\nDuration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '3.7'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '3.7'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '6.5'}, {'value': '3.7', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '5.3'}, {'value': '3.1', 'groupId': 'OG004', 'lowerLimit': '1.8', 'upperLimit': '5.4'}, {'value': '3.8', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '11.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 (up to 28 days)', 'description': 'Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.\n\nPFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.'}, {'type': 'SECONDARY', 'title': 'Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II (Dose Expansion)', 'description': 'Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.'}], 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': "Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.\n\nOverall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as 'Objective response rate' in some protocols or publications.\n\nDue to an enrollment halt, the Phase II part of the study was not conducted.", 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.'}, {'type': 'SECONDARY', 'title': 'Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II (Dose Expansion)', 'description': 'Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.'}], 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': "Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.\n\nThe best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.\n\nDue to an enrollment halt, the Phase II part of the study was not conducted.", 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.'}, {'type': 'SECONDARY', 'title': 'Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II (Dose Expansion)', 'description': 'Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.'}], 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': 'Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.\n\nDuration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.'}, {'type': 'SECONDARY', 'title': 'Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II (Dose Expansion)', 'description': 'Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.'}], 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': 'Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.\n\nOverall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause.\n\nDue to an enrollment halt, the Phase II part of the study was not conducted.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'categories': [{'measurements': [{'value': '7448.5', 'spread': '46.34', 'groupId': 'OG000'}, {'value': '7136', 'spread': '25.09', 'groupId': 'OG001'}, {'value': '15090', 'spread': '53.89', 'groupId': 'OG002'}, {'value': '14051.2', 'spread': '45.83', 'groupId': 'OG003'}, {'value': '18840.8', 'spread': '36.24', 'groupId': 'OG004'}, {'value': '15217.1', 'spread': '71.48', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.', 'unitOfMeasure': 'hr*ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.'}, {'type': 'SECONDARY', 'title': 'Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'categories': [{'measurements': [{'value': '1837.5', 'spread': '35.9', 'groupId': 'OG000'}, {'value': '1932.5', 'spread': '31.18', 'groupId': 'OG001'}, {'value': '2968.1', 'spread': '58.32', 'groupId': 'OG002'}, {'value': '2813', 'spread': '36.83', 'groupId': 'OG003'}, {'value': '4459', 'spread': '26.45', 'groupId': 'OG004'}, {'value': '3768.7', 'spread': '57.12', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.'}, {'type': 'SECONDARY', 'title': 'Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '4'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '1.9'}, {'value': '1', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2.1', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '5.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'categories': [{'measurements': [{'value': '5879.9', 'spread': '32.46', 'groupId': 'OG000'}, {'value': '6330.3', 'spread': '29.28', 'groupId': 'OG001'}, {'value': '16737.1', 'spread': '17.56', 'groupId': 'OG002'}, {'value': '15313.6', 'spread': '105.21', 'groupId': 'OG003'}, {'value': '15055.5', 'spread': '78.89', 'groupId': 'OG004'}, {'value': '20629.7', 'spread': '11.81', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (Day 15)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.', 'unitOfMeasure': 'hr*ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.'}, {'type': 'SECONDARY', 'title': 'Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'categories': [{'measurements': [{'value': '1244.6', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '1347.1', 'spread': '28.56', 'groupId': 'OG001'}, {'value': '3065.6', 'spread': '60.1', 'groupId': 'OG002'}, {'value': '3263.8', 'spread': '96.11', 'groupId': 'OG003'}, {'value': '3597.2', 'spread': '62.84', 'groupId': 'OG004'}, {'value': '3716.5', 'spread': '23.72', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (Day 15)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. 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The PAS will be used for summaries (tables and figures) and listings of PK data.'}, {'type': 'SECONDARY', 'title': 'Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '8.3'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '4.2'}, {'value': '3.9', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '4.2'}, {'value': '1.9', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '2.1'}, {'value': '2.1', 'groupId': 'OG005', 'lowerLimit': '2', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 (Day 15)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'categories': [{'measurements': [{'value': '1587.7', 'spread': '55.75', 'groupId': 'OG000'}, {'value': '1496.7', 'spread': '30.02', 'groupId': 'OG001'}, {'value': '1088.7', 'spread': '49.45', 'groupId': 'OG002'}, {'value': '1590.5', 'spread': '43.49', 'groupId': 'OG003'}, {'value': '984.4', 'spread': '72.57', 'groupId': 'OG004'}, {'value': '962', 'spread': '50.15', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. 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The PAS will be used for summaries (tables and figures) and listings of PK data.'}, {'type': 'SECONDARY', 'title': 'Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'categories': [{'measurements': [{'value': '362', 'spread': '46.74', 'groupId': 'OG000'}, {'value': '432.6', 'spread': '56.3', 'groupId': 'OG001'}, {'value': '245.4', 'spread': '63.08', 'groupId': 'OG002'}, {'value': '328.4', 'spread': '59.07', 'groupId': 'OG003'}, {'value': '243.5', 'spread': '53.27', 'groupId': 'OG004'}, {'value': '222.8', 'spread': '58.13', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. 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The PAS will be used for summaries (tables and figures) and listings of PK data.'}, {'type': 'SECONDARY', 'title': 'Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'OG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '8.3'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '8.2'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '4.1'}, {'value': '1.9', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '2.1'}, {'value': '1.5', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 (Day 15)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'FG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'FG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'FG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'FG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'FG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The CMEK162X2203 study began recruitment on 26-Aug-2013 and concluded on 15-May-2015. Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.', 'preAssignmentDetails': 'Participant Flow and Baseline Demographics data represents the Full Analysis Set (FAS), which includes all patients who received at least one full or partial dose of sotrastaurin or binimetinib.\n\nNot completed subjects represents subjects that stopped treatment early, due to the corresponding reason.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'BG001', 'title': 'Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'BG002', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'BG003', 'title': 'Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'BG004', 'title': 'Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'BG005', 'title': 'Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)', 'description': 'Phase Ib (Dose Escalation)\n\nPhase Ib was the combination of sotrastaurin and binimetinib administered orally bid.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.7', 'spread': '15.21', 'groupId': 'BG000'}, {'value': '57.0', 'spread': '10.43', 'groupId': 'BG001'}, {'value': '52.8', 'spread': '10.82', 'groupId': 'BG002'}, {'value': '59.8', 'spread': '9.11', 'groupId': 'BG003'}, {'value': '56.8', 'spread': '10.87', 'groupId': 'BG004'}, {'value': '61.5', 'spread': '10.65', 'groupId': 'BG005'}, {'value': '56.4', 'spread': '11.39', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}, {'title': 'Russian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline WHO Performance Status', 'classes': [{'title': '0:', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}]}]}, {'title': '1:', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Categories:\n\n* 0 - Fully active, able to carry on all pre-disease performance without restriction\n* 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\n* 2 - Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours\n* 3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours\n* 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline Demographics data represents the Full Analysis Set (FAS), which includes all patients who received at least one full or partial dose of sotrastaurin or binimetinib.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'The trial was terminated for scientific reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'dispFirstSubmitDate': '2016-02-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2013-02-21', 'dispFirstSubmitQcDate': '2016-02-11', 'resultsFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2013-02-27', 'dispFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-29', 'studyFirstPostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle', 'timeFrame': 'Cycle 1 (up to 28 days)', 'description': 'A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.'}, {'measure': 'Phase II: Progression Free Survival (PFS)', 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': 'The time from date of randomization to the date of event defined as the first documented progression or death due to any cause.\n\nDue to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.'}], 'secondaryOutcomes': [{'measure': 'Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)', 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': "An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained."}, {'measure': 'Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)', 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': "Serious adverse event (SAE) is defined as one of the following:\n\n* Is fatal or life-threatening\n* Results in persistent or significant disability/incapacity\n* Constitutes a congenital anomaly/birth defect\n* Is medically significant\n* Requires inpatient hospitalization or prolongation of existing hospitalization\n* Note that hospitalizations for the following reasons should not be reported as serious adverse events:\n\n * Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition\n * Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent\n * Social reasons and respite care in the absence of any deterioration in the patient's general condition"}, {'measure': 'Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)', 'timeFrame': 'Cycle 1 (up to 28 days)', 'description': "Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.\n\nThe best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria."}, {'measure': 'Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)', 'timeFrame': 'Cycle 1 (up to 28 days)', 'description': 'Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.\n\nDuration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study.'}, {'measure': 'Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)', 'timeFrame': 'Cycle 1 (up to 28 days)', 'description': 'Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.\n\nPFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.'}, {'measure': 'Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)', 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': "Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.\n\nOverall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as 'Objective response rate' in some protocols or publications.\n\nDue to an enrollment halt, the Phase II part of the study was not conducted."}, {'measure': 'Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)', 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': "Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.\n\nThe best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.\n\nDue to an enrollment halt, the Phase II part of the study was not conducted."}, {'measure': 'Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)', 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': 'Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.\n\nDuration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study.'}, {'measure': 'Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)', 'timeFrame': 'From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)', 'description': 'Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.\n\nOverall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause.\n\nDue to an enrollment halt, the Phase II part of the study was not conducted.'}, {'measure': 'Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)', 'timeFrame': 'Cycle 1 (Day 15)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)', 'timeFrame': 'Cycle 1 (Day 15)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)', 'timeFrame': 'Cycle 1 (Day 15)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)', 'timeFrame': 'Cycle 1 (Day 1)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)', 'timeFrame': 'Cycle 1 (Day 15)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)', 'timeFrame': 'Cycle 1 (Day 15)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}, {'measure': 'Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)', 'timeFrame': 'Cycle 1 (Day 15)', 'description': 'Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Melanoma,', 'melanoma of the eye,', 'uveal,', 'MEK162,', 'AEB071'], 'conditions': ['Uveal Melanoma']}, 'descriptionModule': {'briefSummary': 'A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed', 'detailedDescription': 'Due to halted enrollment, the Phase II part of the study was not conducted. The Sponsor decided to permanently stop recruitment for the study prior to MTD determination.\n\nRemaining patients on treatment with binimetinib and sotrastaurin who were considered by the Investigator to be benefiting from their treatment could have continued treatment and were to be followed up as per protocol. No patients were ongoing as of the data cut-off date. After the last patient last visit (LPLV) was declared, the study was terminated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Male and female patients aged 18 years or older\n* A history of uveal (ocular) melanoma with biopsy-confirmed metastatic disease\n* Consent to providing 3 tumor biopsy samples throughout the course of the study\n* Presence of measurable disease\n* A WHO performance status of less than or equal to 1\n\nExclusion Criteria:\n\n* Presence of CNS lesions (stable lesions may be acceptable)\n* Previous or concurrent malignancy, other than basal cell or squamous cell carcinoma of the skin: in situ carcinoma of the cervix, without evidence of recurrence for at least 3 years; a primary malignancy completely resected and no evidence of recurrence for at least 3 years\n* Adverse event from prior chemotherapy, radiotherapy or surgery that has not recovered to CTCAE v4.03 Grade 1 or less, except for alopecia/sensory peripheral neuropathy, which must be less than Grade 2\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO\n* Impaired cardiac function or clinically significant cardiac disease\n* Impaired GI function or disease that could interfere with the absorption of AEB071 and/or MEK162\n* Treatment with medicines or herbal supplements that are known inhibitors or inducers of CYP3A4/5 and cannot be withdrawn prior to study treatment\n* Females of child-bearing potential who are unwilling or unable to use highly effective means of contraception\n* Males who are unwilling or unable to use a condom during sexual intercourse\n* Prior exposure to a MEK or PKC inhibitor Other inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT01801358', 'briefTitle': 'A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Array BioPharma'}, 'officialTitle': 'A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma', 'orgStudyIdInfo': {'id': 'CMEK162X2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'AEB071 and MEK162 combined', 'interventionNames': ['Drug: AEB071', 'Drug: MEK162']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'MEK162 alone', 'interventionNames': ['Drug: MEK162']}], 'interventions': [{'name': 'AEB071', 'type': 'DRUG', 'otherNames': ['Sotrastaurin'], 'description': 'Twice-daily doses of AEB071 for a cycle of 28-days, given without interruption (continuous cycles)', 'armGroupLabels': ['Arm A']}, {'name': 'MEK162', 'type': 'DRUG', 'description': 'Twice-daily doses of MEK162 for a cycle of 28-days, given without interruption (continuous cycles)', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute Dept. Onc', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '90033', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center Dept of Onc..', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75231', 'city': 'Paris', 'country': 'France', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '2300 RC', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Array Biopharma, now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}