Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/25/2018 |
| Start Date: | August 2011 |
| End Date: | December 18, 2017 |
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
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.
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.
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
We found this trial at
6
sites
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