Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT02468557
Status:
TERMINATED
Last Update Posted:
2021-04-02
First Post:
2015-06-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552946', 'term': 'idelalisib'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the early termination of the study, the prespecified efficacy, pharmacodynamic, and pharmacokinetic analysis for PK parameters were not conducted.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)', 'description': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 2, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rectal spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Xerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Onycholysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose date (Maximum: 8 weeks) plus 30 days', 'description': 'TEAEs were defined as adverse events (AEs) with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the study drug. It also included the AEs that led to premature discontinuation of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.'}], 'classes': [{'title': 'Hemoglobin (Hypo), Hematology', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes (Hyper), Hematology', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes (Hypo), Hematology', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Hematology', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase, Chemistry', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Chemistry', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase, Chemistry', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase, Chemistry', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Chemistry', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine Clearance, Chemistry', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Gamma Glutamyl Transferase, Chemistry', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Glucose (Hyper), Chemistry', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Sodium (Hypo), Chemistry', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose date (Maximum: 8 weeks) plus 30 days', 'description': "Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post baseline time point, up to and including the date of last dose of study drug plus 30 days. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Severity grade is defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening). The percentage of participants for any post-baseline abnormal laboratory value in the Grade 1-4 category is reported. The term 'hypo' indicates less than the normal count of a parameter and 'hyper' indicates more than the normal count of a parameter.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the safety analysis set were analysed.'}, {'type': 'PRIMARY', 'title': 'Idelalisib in Combination With Chemotherapy: Percentage of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idelalisib + Nab-paclitaxel', 'description': 'Participants were to be administered IDL tablets orally twice daily plus nab-paclitaxel administered intravenously on Days 1, 8 and 15 of each 28 day cycle.'}, {'id': 'OG001', 'title': 'Idelalisib + mFOLFOX6', 'description': 'Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.'}], 'timeFrame': 'Up to 28 days', 'description': 'Dose limiting toxicities were defined as toxicities experienced during the first 28 days of treatment (Cycle 1) that were judged to be clinically significant and at least possibly related to study treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the early termination of the study, there were no participants enrolled in the Idelalisib Combination arms.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FoxP3+ and Cluster Determinant 8+ (CD8+) Cells From Tumor Tissue Samples as a Measure of Pharmacodynamics Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.'}, {'id': 'OG001', 'title': 'Idelalisib + Nab-paclitaxel', 'description': 'Participants were to be administered IDL tablets orally twice daily plus nab-paclitaxel administered intravenously on Days 1, 8 and 15 of each 28 day cycle.'}, {'id': 'OG002', 'title': 'Idelalisib + mFOLFOX6', 'description': 'Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.'}], 'timeFrame': 'Up to 2 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the early termination of the study no pharmacodynamic testing was performed.'}, {'type': 'SECONDARY', 'title': 'Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.'}], 'classes': [{'title': 'Cycle 1; Day 1 (Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The plasma concentration of IDL was below the limit of quantitation.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Cycle 1; Day 1 (0.5 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1110', 'groupId': 'OG000', 'lowerLimit': '13.90', 'upperLimit': '3220'}]}]}, {'title': 'Cycle 1; Day 1 (1 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1880', 'groupId': 'OG000', 'lowerLimit': '39.10', 'upperLimit': '4060'}]}]}, {'title': 'Cycle 1; Day 1 (1.5 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1690', 'groupId': 'OG000', 'lowerLimit': '318', 'upperLimit': '2260'}]}]}, {'title': 'Cycle 1; Day 1 (2 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1290', 'groupId': 'OG000', 'lowerLimit': '173', 'upperLimit': '4460'}]}]}, {'title': 'Cycle 1; Day 1 (3 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '795', 'groupId': 'OG000', 'lowerLimit': '631', 'upperLimit': '2870'}]}]}, {'title': 'Cycle 1; Day 1 (4 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1540', 'groupId': 'OG000', 'lowerLimit': '519', 'upperLimit': '1990'}]}]}, {'title': 'Cycle 1; Day 1 (8 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000', 'lowerLimit': '134', 'upperLimit': '753'}]}]}, {'title': 'Cycle 1; Day 8 (Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000', 'lowerLimit': '208', 'upperLimit': '501.5'}]}]}, {'title': 'Cycle 1; Day 8 (1.5 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2050', 'groupId': 'OG000', 'lowerLimit': '1335', 'upperLimit': '2620'}]}]}, {'title': 'Cycle 1; Day 15 (Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '275', 'groupId': 'OG000', 'lowerLimit': '241', 'upperLimit': '1120'}]}]}, {'title': 'Cycle 1; Day 15 (1.5 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1605', 'groupId': 'OG000', 'lowerLimit': '1170', 'upperLimit': '2130'}]}]}, {'title': 'Cycle 2; Day 1 (Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '178.05', 'groupId': 'OG000', 'lowerLimit': '39.05', 'upperLimit': '281'}]}]}, {'title': 'Cycle 2; Day 1 (1.5 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2180', 'groupId': 'OG000', 'lowerLimit': '1825', 'upperLimit': '3095'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 hours (h) postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) Analysis Set included all participants in the Full Analysis Set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest. Due to the early termination of the study, concentration data is reported because there was an insufficient number of participants sampled for PK analysis to generate PK parameters.'}, {'type': 'SECONDARY', 'title': 'Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.'}], 'classes': [{'title': 'Cycle 1; Day 1 (Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The plasma concentration of GS-563117 was below the limit of quantitation.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Cycle 1; Day 1 (0.5 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '173', 'comment': 'The plasma concentration of GS-563117 was below the limit of quantitation.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '220'}]}]}, {'title': 'Cycle 1; Day 1 (1 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1220', 'groupId': 'OG000', 'lowerLimit': '16.70', 'upperLimit': '1460'}]}]}, {'title': 'Cycle 1; Day 1 (1.5 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1070', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '1930'}]}]}, {'title': 'Cycle 1; Day 1 (2 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1700', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': '4430'}]}]}, {'title': 'Cycle 1; Day 1 (3 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1580', 'groupId': 'OG000', 'lowerLimit': '190', 'upperLimit': '5980'}]}]}, {'title': 'Cycle 1; Day 1 (4 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1370', 'groupId': 'OG000', 'lowerLimit': '849', 'upperLimit': '5960'}]}]}, {'title': 'Cycle 1; Day 1 (8 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '632', 'groupId': 'OG000', 'lowerLimit': '619', 'upperLimit': '5340'}]}]}, {'title': 'Cycle 1; Day 8 (Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2175', 'groupId': 'OG000', 'lowerLimit': '1385', 'upperLimit': '5790'}]}]}, {'title': 'Cycle 1; Day 8 (1.5 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2775', 'groupId': 'OG000', 'lowerLimit': '1765', 'upperLimit': '5725'}]}]}, {'title': 'Cycle 1; Day 15 (Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2130', 'groupId': 'OG000', 'lowerLimit': '1020', 'upperLimit': '6800'}]}]}, {'title': 'Cycle 1; Day 15 (1.5 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2890', 'groupId': 'OG000', 'lowerLimit': '2010', 'upperLimit': '4815'}]}]}, {'title': 'Cycle 2; Day 1 (Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1046.5', 'groupId': 'OG000', 'lowerLimit': '490.34', 'upperLimit': '1360'}]}]}, {'title': 'Cycle 2; Day 1 (1.5 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1405', 'groupId': 'OG000', 'lowerLimit': '1325', 'upperLimit': '2305'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 h postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Analysis Set with available data were analysed. Due to the early termination of the study, concentration data is reported because there was an insufficient number of participants sampled for PK analysis to generate PK parameters.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.'}, {'id': 'OG001', 'title': 'Idelalisib + Nab-paclitaxel', 'description': 'Participants were to be administered IDL tablets orally twice daily plus nab-paclitaxel administered intravenously on Days 1, 8 and 15 of each 28 day cycle.'}, {'id': 'OG002', 'title': 'Idelalisib + mFOLFOX6', 'description': 'Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.'}], 'timeFrame': 'Up to 2 years', 'description': 'Overall response rate (ORR) was defined as the percentage of participants who achieved a Complete Response (CR) or Partial Response (PR) as assessed by response evaluation criteria in sold tumors (RECIST) v1.1.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, the prespecified efficacy analyses were not conducted.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.'}, {'id': 'OG001', 'title': 'Idelalisib + Nab-paclitaxel', 'description': 'Participants were to be administered IDL tablets orally twice daily plus nab-paclitaxel administered intravenously on Days 1, 8 and 15 of each 28 day cycle.'}, {'id': 'OG002', 'title': 'Idelalisib + mFOLFOX6', 'description': 'Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.'}], 'timeFrame': 'Up to 2 years', 'description': 'Overall survival is defined as the interval from first dose date of study drug to death from any cause.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, the prespecified efficacy analyses were not conducted.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.'}, {'id': 'OG001', 'title': 'Idelalisib + Nab-paclitaxel', 'description': 'Participants were to be administered IDL tablets orally twice daily plus nab-paclitaxel administered intravenously on Days 1, 8 and 15 of each 28 day cycle.'}, {'id': 'OG002', 'title': 'Idelalisib + mFOLFOX6', 'description': 'Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.'}], 'timeFrame': 'Up to 2 years', 'description': 'Progression free survival is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression or death from any cause.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, the prespecified efficacy analyses were not conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study Terminated by Sponsor, Regulatory Agency or Institutional Review Board/ Ethics Committee', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'All Enrolled but Never Dosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in the United States. The first participant was screened on 30 July 2015. The last study visit occurred on 27 April 2016.', 'preAssignmentDetails': '35 participants were screened. The study was terminated. No participants were enrolled in the Idelalisib (IDL) + nab-paclitaxel or IDL + mFOLFOX \\[5- fluorouracil (FU), leucovorin and oxaliplatin\\] groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Permitted', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Not Permitted means local regulators did not allow collection of race information.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Permitted', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Not Permitted means local regulators did not allow collection of ethnicity information.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set included all participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2016-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-31', 'studyFirstSubmitDate': '2015-06-08', 'resultsFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-25', 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'First dose date up to last dose date (Maximum: 8 weeks) plus 30 days', 'description': 'TEAEs were defined as adverse events (AEs) with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the study drug. It also included the AEs that led to premature discontinuation of study drug.'}, {'measure': 'Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities', 'timeFrame': 'First dose date up to last dose date (Maximum: 8 weeks) plus 30 days', 'description': "Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post baseline time point, up to and including the date of last dose of study drug plus 30 days. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Severity grade is defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening). The percentage of participants for any post-baseline abnormal laboratory value in the Grade 1-4 category is reported. The term 'hypo' indicates less than the normal count of a parameter and 'hyper' indicates more than the normal count of a parameter."}, {'measure': 'Idelalisib in Combination With Chemotherapy: Percentage of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Up to 28 days', 'description': 'Dose limiting toxicities were defined as toxicities experienced during the first 28 days of treatment (Cycle 1) that were judged to be clinically significant and at least possibly related to study treatment.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FoxP3+ and Cluster Determinant 8+ (CD8+) Cells From Tumor Tissue Samples as a Measure of Pharmacodynamics Activity', 'timeFrame': 'Up to 2 years'}, {'measure': 'Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily', 'timeFrame': 'Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 hours (h) postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdose'}, {'measure': 'Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily', 'timeFrame': 'Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 h postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdose'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to 2 years', 'description': 'Overall response rate (ORR) was defined as the percentage of participants who achieved a Complete Response (CR) or Partial Response (PR) as assessed by response evaluation criteria in sold tumors (RECIST) v1.1.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 2 years', 'description': 'Overall survival is defined as the interval from first dose date of study drug to death from any cause.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'Progression free survival is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression or death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Previously Untreated Pancreatic Ductal Adenocarcinoma', 'Relapsed/Refractory Pancreatic Ductal Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '32356383', 'type': 'BACKGROUND', 'citation': 'Borazanci E, Pishvaian MJ, Nemunaitis J, Weekes C, Huang J, Rajakumaraswamy N. A Phase Ib Study of Single-Agent Idelalisib Followed by Idelalisib in Combination with Chemotherapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma. Oncologist. 2020 Nov;25(11):e1604-e1613. doi: 10.1634/theoncologist.2020-0321. Epub 2020 Jun 18.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety of single agent idelalisib and to evaluate safety and define the maximum tolerated dose (MTD) of idelalisib in combination with chemotherapy in adults with metastatic pancreatic ductal adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* The presence of metastatic pancreatic adenocarcinoma plus 1 of the following:\n\n * Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR\n * Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreas origin\n* Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1\n* Prior systemic chemotherapy treatment for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib single agent only)\n* Received one prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + mFOLFOX6 only)\n* Adequate organ function defined as follows:\n\n * Hepatic: Total bilirubin ≤ 1.25 x upper limit of normal (ULN) (Arm: idelalisib + nab-paclitaxel ); total bilirubin ≤1.5 x ULN (Arm: single agent idelalisib and Arm: idelalisib + mFOLFOX6); aspartate transaminase (AST) serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT) serum glutamic pyruvic transaminase (SGPT) \\< 2.5 x ULN, and albumin \\> 3.0 g/dL\n * Hematological: absolute neutrophil count (ANC) \\> 1,500 cells/cubic millimetre (m\\^3), platelet \\> 100,000 cells/mm\\^3, hemoglobin \\> 9.0 grams/decilitre (g/dL)\n * Renal: Serum creatinine ≤ 1.5 x ULN OR calculated creatinine clearance (CrCl) \\> 30 millilitre (ml)/min as calculated by the Cockcroft-Gault method\n* Able to comprehend and willing to sign the written informed consent form\n\nKey Exclusion Criteria:\n\n* Currently or previously treated with biologic, or immunotherapy\n* Currently or previously treated with conventional chemotherapy, or other agents for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + nab-paclitaxel only)\n* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment\n* Known human immunodeficiency viruses (HIV) infection\n* History of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to enrollment, adequately treated Stage 1 or 2 non-pancreatic cancer currently in complete remission, or any other non-pancreatic cancer that has been in complete remission for ≥ 5 years\n* Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma), adenocarcinoma originating from the biliary tree or cystadenocarcinoma\n* History of serious allergic reaction, including anaphylaxis and toxic epidermal necrolysis\n* Presence of peripheral neuropathy ≥ Grade 2 (Arm: idelalisib + nab-paclitaxel and Arm: idelalisib + mFOLFOX6)\n* Documented myocardial infarction or unstable/uncontrolled cardiac disease (eg, unstable angina, congestive heart failure \\[New York Heart Association \\> Class III\\]) within 6 months or enrollment\n* Known hypersensitivity to idelalisib, its metabolites, or formulation excipients\n* Known hypersensitivity to nab-paclitaxel (Arm: idelalisib + nab-paclitaxel), their metabolites, or formulation excipients\n* Known hypersensitivity to 5-fluorouracil, leucovorin, or oxaliplatin (Arm: idelalisib + mFOLFOX6), their metabolites, or formulation excipients\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02468557', 'briefTitle': 'Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1b Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'GS-US-385-1577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Idelalisib 150 mg', 'description': 'Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.', 'interventionNames': ['Drug: Idelalisib']}, {'type': 'EXPERIMENTAL', 'label': 'Idelalisib + nab-paclitaxel', 'description': 'Participants will receive escalating doses of idelalisib at a dose level of up to 150mg + nab-paclitaxel.', 'interventionNames': ['Drug: Idelalisib', 'Drug: Nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Idelalisib + mFOLFOX6', 'description': 'Participants will receive escalating doses of idelalisib at a dose level of up to 150mg + mFOLFOX6.', 'interventionNames': ['Drug: Idelalisib', 'Drug: mFOLFOX6']}], 'interventions': [{'name': 'Idelalisib', 'type': 'DRUG', 'otherNames': ['GS-1101', 'CAL-101', 'Zydelig®'], 'description': 'Tablets administered orally twice daily', 'armGroupLabels': ['Idelalisib + mFOLFOX6', 'Idelalisib + nab-paclitaxel', 'Idelalisib 150 mg']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'description': '125 mg/m\\^2 administered intravenously on Days 1, 8 and 15 of each 28 day cycle', 'armGroupLabels': ['Idelalisib + nab-paclitaxel']}, {'name': 'mFOLFOX6', 'type': 'DRUG', 'description': 'mFOLFOX6 will be administered intravenously on Days 1 and 15 of each 28 day cycle. This regimen consists of levoleucovorin 200 milligram/meter per square (mg/m\\^2) or racemic leucovorin 400 mg/m\\^2, oxaliplatin 85 mg/m\\^2, bolus 5-fluorouracil 400 mg/m\\^2, and a 46 hour infusion of 5-fluorouracil 2, 400 mg/m\\^2.', 'armGroupLabels': ['Idelalisib + mFOLFOX6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Healthcare Clinical Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '46506', 'city': 'Goshen', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Goshen Center for Cancer Care', 'geoPoint': {'lat': 41.58227, 'lon': -85.83444}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber/ Harvard Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Medical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}