The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BKM120 in the treatment of 3rd line GIST patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Dana Farber Cancer Institute SC (2)
Boston, Massachusetts, United States
Seattle Cancer Care Alliance Onc
Seattle, Washington, United States
Novartis Investigative Site
Leuven, Belgium
Frequency and characteristics of dose limiting toxicities (DLTs) at each dose level during the first cycle of therapy
Dose limiting toxicity (DLT) will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) (v4.0.3), unless otherwise specified in the protocol.
Time frame: 28 days (1st cycle)
Frequency and characteristics of DLTs at each dose level during the first cycle of therapy. Type, frequency and severity of adverse drug reactions.
Dose limiting toxicity (DLT) will be assessed using CTCAE (v4.0.3), unless otherwise specified in the protocol.
Time frame: 28 days (1st cycle)
Imatinib and BKM120 plasma concentrations vs time profile, and basic PK parameters, including but not limited to AUC, Cmax, Tmax, CL/F.
Time frame: 28 days (1st cycle)
Clinical benefit rate (CBR) defined as the rate of confirmed complete response (CR) or partial response (PR), or stable disease (SD) which lasts for at least 16 weeks.
Tumor response will be determined locally by the investigator sites according to Novartis guideline on the Response Evaluation Criteria in Solid Tumors, based on RECIST Version 1.1.
Time frame: 28 days (1st cycle)
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Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Leiden, Netherlands
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
London, United Kingdom
...and 1 more locations