Advanced Solid Tumors Clinical Trial
Official title:
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
| Verified date | September 2020 |
| Source | Array BioPharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 89 |
| Est. completion date | December 18, 2017 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Histologically/ cytologically confirmed, advanced non resectable solid tumors - Measurable or non-measurable, but evaluable disease as determined by RECIST Exclusion Criteria: - Patients with primary CNS tumor or CNS tumor involvement. - Diabetes mellitus - Unacceptable ocular/retinal conditions |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Pfizer Investigative Site | Toronto | Ontario |
| Germany | Pfizer Investigative Site | Essen | |
| Germany | Pfizer Investigative Site | Heidelberg | |
| Netherlands | Pfizer Investigative Site | Utrecht | |
| Singapore | Pfizer Investigative Site | Singapore | |
| Spain | Pfizer Investigative Site | Barcelona | Catalunya |
| Switzerland | Pfizer Investigative Site | Bellinzona | |
| United States | Massachusetts General Hospital Mass General 2 | Boston | Massachusetts |
| United States | Karmanos Cancer Institute Study Coordinator | Detroit | Michigan |
| 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 | Memorial Sloan Kettering Cancer Center MSKCC (2) | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Array Biopharma, now a wholly owned subsidiary of Pfizer |
United States, Canada, Germany, Netherlands, Singapore, Spain, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Dose Limiting Toxicities | during Cycle 1 of treatment with BKM120 and MEK162 | ||
| Secondary | Number of participants with adverse events and serious adverse events. | from Cycle 1 Day 1 until treatment discontinuation | ||
| Secondary | Overall response rate, duration of response, time to response and progression free survival | every 8 weeks of treatment | ||
| Secondary | Time versus plasma concentration profiles of BKM120 and MEK162 | during the first cycle of treatment on Cycle 1 Day 1 and Cycle 1 Day 15 | ||
| Secondary | Treatment -induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor. | during the first cycle of treatment on Cycle 1 Day 15 and at disease progression |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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