A Phase 1 interventional study of BKM120 + MEK162 in Advanced Solid Tumors and Selected Solid Tumors, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer. Completed at 12 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-05.
Sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment
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.
Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 89 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Array Biopharma, now a wholly owned subsidiary of Pfizer is the lead sponsor of 25 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: BKM120 + MEK162
Incidence of Dose Limiting Toxicities
Time frame: during Cycle 1 of treatment with BKM120 and MEK162
Number of participants with adverse events and serious adverse events.
Time frame: from Cycle 1 Day 1 until treatment discontinuation
Overall response rate, duration of response, time to response and progression free survival
Time frame: every 8 weeks of treatment
Time versus plasma concentration profiles of BKM120 and MEK162
Time frame: during the first cycle of treatment on Cycle 1 Day 1 and Cycle 1 Day 15
Treatment -induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor.
Time frame: during the first cycle of treatment on Cycle 1 Day 15 and at disease progression
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Array Biopharma, now a wholly owned subsidiary of Pfizer