Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2011 |
| End Date: | March 2013 |
A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BEZ235 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 RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in
combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients
with EGFR mutant 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 BEZ235 and MEK162.
Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd,
a treatment cycle is defined as 28 days.
tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in
combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients
with EGFR mutant 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 BEZ235 and MEK162.
Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd,
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 1.0
Exclusion Criteria:
- Patients with primary CNS tumor or CNS tumor involvement
- Diabetes mellitus - Unacceptable ocular/retinal conditions
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
3
sites
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