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

Status: Recruiting
Phase: Phase 2
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01449058 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-490


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 or other advanced solid tumors with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, three 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.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Jose Baselga M.D., Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically/cytologically confirmed, advanced solid tumors - 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
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