Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients
Completed · Phase 1
Conditions studied: Advanced Solid Tumors, Selected Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT01363232
- Run by
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- People needed
- 89
- Starts
- 2011-08-01
- Expected to finish
- 2017-12-18
- Last updated by the study team
- 2020-10-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically/ cytologically confirmed, advanced non resectable solid tumors
- Measurable or non-measurable, but evaluable disease as determined by RECIST
You may not qualify if…
- Patients with primary CNS tumor or CNS tumor involvement.
- Diabetes mellitus
- Unacceptable ocular/retinal conditions
Where it is running
- Massachusetts General Hospital Mass General 2 — Boston, Massachusetts, United States
- Karmanos Cancer Institute Study Coordinator — Detroit, Michigan, United States
- Memorial Sloan Kettering Cancer Center MSKCC (2) — New York, New York, United States
- Cancer Centers of the Carolinas CCC Faris — Greenville, South Carolina, United States
- University of Texas/MD Anderson Cancer Center MD Anderson PSC — Houston, Texas, United States
- Pfizer Investigative Site — Toronto, Ontario, Canada
- Pfizer Investigative Site — Essen, Germany
- Pfizer Investigative Site — Heidelberg, Germany
- Pfizer Investigative Site — Utrecht, Netherlands
- Pfizer Investigative Site — Singapore, Singapore
- Pfizer Investigative Site — Barcelona, Catalonia, Spain
- Pfizer Investigative Site — Bellinzona, Switzerland
Full record on ClinicalTrials.gov
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