Status:
COMPLETED
A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors
Lead Sponsor:
Array BioPharma
Conditions:
Advanced and Selected Solid Tumors
AML
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 combin...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed, advanced solid tumors, AML or high risk and very high risk MDS
- Measurable disease as determined by RECIST 1.1
Exclusion
- Primary CNS tumor or CNS tumor involvement
- Diabetes mellitus
- Unacceptable ocular/retinal conditions
- Clinically significant cardiac disease or impaired cardiac function
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2017
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT01449058
Start Date
March 1 2012
End Date
August 15 2017
Last Update
October 2 2017
Active Locations (16)
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1
University of California San Diego - Moores Cancer Center Dept Onc
La Jolla, California, United States, 92093-0658
2
H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC
Tampa, Florida, United States, 33612
3
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
4
Massachusetts General Hospital CCPO
Boston, Massachusetts, United States, 02114