Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-26 @ 5:07 PM
Study NCT ID:
NCT01363232
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571178', 'term': 'NVP-BKM120'}, {'id': 'C581313', 'term': 'binimetinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2011-05-31', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Dose Limiting Toxicities', 'timeFrame': 'during Cycle 1 of treatment with BKM120 and MEK162'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events and serious adverse events.', 'timeFrame': 'from Cycle 1 Day 1 until treatment discontinuation'}, {'measure': 'Overall response rate, duration of response, time to response and progression free survival', 'timeFrame': 'every 8 weeks of treatment'}, {'measure': 'Time versus plasma concentration profiles of BKM120 and MEK162', 'timeFrame': 'during the first cycle of treatment on Cycle 1 Day 1 and Cycle 1 Day 15'}, {'measure': 'Treatment -induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor.', 'timeFrame': 'during the first cycle of treatment on Cycle 1 Day 15 and at disease progression'}]}, 'conditionsModule': {'keywords': ['BKM120', 'MEK162', 'RAS RAF mutations', 'triple negative breast cancer', 'pancreatic cancer, ovarian cancer', 'NSCLC progressed on EGFR TKI', 'PI3K inhibitor', 'MEK inhibitor'], 'conditions': ['Advanced Solid Tumors', 'Selected Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '31395751', 'type': 'DERIVED', 'citation': 'Bardia A, Gounder M, Rodon J, Janku F, Lolkema MP, Stephenson JJ, Bedard PL, Schuler M, Sessa C, LoRusso P, Thomas M, Maacke H, Evans H, Sun Y, Tan DSW. Phase Ib Study of Combination Therapy with MEK Inhibitor Binimetinib and Phosphatidylinositol 3-Kinase Inhibitor Buparlisib in Patients with Advanced Solid Tumors with RAS/RAF Alterations. Oncologist. 2020 Jan;25(1):e160-e169. doi: 10.1634/theoncologist.2019-0297. Epub 2019 Aug 8.'}]}, 'descriptionModule': {'briefSummary': "This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.\n\nStudy drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically/ cytologically confirmed, advanced non resectable solid tumors\n* Measurable or non-measurable, but evaluable disease as determined by RECIST\n\nExclusion Criteria:\n\n* Patients with primary CNS tumor or CNS tumor involvement.\n* Diabetes mellitus\n* Unacceptable ocular/retinal conditions'}, 'identificationModule': {'nctId': 'NCT01363232', 'briefTitle': 'Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Array BioPharma'}, 'officialTitle': 'A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BKM120 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'CMEK162X2101'}, 'secondaryIdInfos': [{'id': '2011-001083-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BKM120 + MEK162', 'interventionNames': ['Drug: BKM120 + MEK162']}], 'interventions': [{'name': 'BKM120 + MEK162', 'type': 'DRUG', 'armGroupLabels': ['BKM120 + MEK162']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Mass General 2', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute Study Coordinator', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '90033', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center MSKCC (2)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas CCC Faris', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas/MD Anderson Cancer Center MD Anderson PSC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '3584CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Pfizer Investigative Site', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '1-800-718-1021'}, {'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'}}}}