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

Completed · Phase 1

Conditions studied: Advanced and Selected Solid Tumors, AML, High Risk and Very High Risk MDS

In brief

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.

Key facts

Study ID

NCT01449058

Run by

Array BioPharma

People needed

139

Starts

2012-03-01

Expected to finish

2017-08-15

Last updated by the study team

2017-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically/cytologically confirmed, advanced solid tumors, AML or high risk and very high risk MDS
• Measurable disease as determined by RECIST 1.1

You may not qualify if…

• Primary CNS tumor or CNS tumor involvement
• Diabetes mellitus
• Unacceptable ocular/retinal conditions
• Clinically significant cardiac disease or impaired cardiac function

Where it is running

• University of California San Diego - Moores Cancer Center Dept Onc — La Jolla, California, United States
• H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC — Tampa, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Massachusetts General Hospital CCPO — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center Onc. Dept — New York, New York, United States
• Montefiore Medical Center SC — The Bronx, New York, United States
• University of Texas/MD Anderson Cancer Center Dept. of Onc. — Houston, Texas, United States
• University of Utah / Huntsman Cancer Institute Huntsman (3) — Salt Lake City, Utah, United States
• Array BioPharma Investigative Site — Parkville, Victoria, Australia
• Array BioPharma Investigative Site — Villejuif, France
• Array BioPharma Investigative Site — Milan, MI, Italy
• Array BioPharma Investigative Site — Roma, RM, Italy
• Array BioPharma Investigative Site — Barcelona, Catalonia, Spain
• Array BioPharma Investigative Site — Barcelona, Catalonia, Spain
• Array BioPharma Investigative Site — Bellinzona, Switzerland
• Array BioPharma Investigative Site — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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