A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

Status:	Completed
Conditions:	Cancer, Blood Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	10/4/2017
Start Date:	March 2012
End Date:	August 15, 2017

A Phase Ib Open-label, Multi-center, Dose Escalation and Expansion Study of Orally Administered MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

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.

Inclusion Criteria:

- Histologically/cytologically confirmed, advanced solid tumors, AML or high risk and
very high risk MDS

- Measurable disease as determined by RECIST 1.1

Exclusion Criteria:

- Primary CNS tumor or CNS tumor involvement

- Diabetes mellitus

- Unacceptable ocular/retinal conditions

- Clinically significant cardiac disease or impaired cardiac function

We found this trial at

sites

Northwestern Memorial Hospital

251 E Huron St
Chicago, Illinois 60611

(312) 926-2000