A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors
Status:
Completed
Trial end date:
2017-08-15
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum
tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally
administered combination of BYL719 and MEK162. This combination will be explored in adult
patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or
other advanced solid tumors and in adult patients with AML or high risk and very high risk
MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian
logistic regression model with overdose control. At MTD or RDE, four expansion arms will be
opened in order to further assess the safety and preliminary activity of the combination of
BYL719 and MEK162 in specific patient populations.