Status:
COMPLETED
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced and Selected Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K (Phosphatidylinositol 3-Ki...
Eligibility Criteria
Inclusion
- histologically/ cytologically confirmed, advanced non resectable solid tumors
- Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
Exclusion
- Patients with primary Central Nervous System (CNS) tumor or CNS tumor involvement.
- Clinically manifested diabetes mellitus - Unacceptable ocular/retinal conditions
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01155453
Start Date
April 1 2010
End Date
November 1 2014
Last Update
December 9 2020
Active Locations (7)
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1
University of California at Los Angeles Div. of Hematology/Oncology
Los Angeles, California, United States, 90095
2
University of Texas/MD Anderson Cancer Center Dept of MD Anderson (8)
Houston, Texas, United States, 77030-4009
3
Novartis Investigative Site
Leuven, Belgium, 3000
4
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9