Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients
Status:
Completed
Trial end date:
2013-03-22
Target enrollment:
Participant gender:
Summary
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.