This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Oral KQB198
Oral Imatinib
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGMayo Clinic - Jacksonville
Jacksonville, Florida, United States
RECRUITINGSylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGUniversity of Chicago Medical Center
Chicago, Illinois, United States
RECRUITINGUniversity of Iowa Health Care
Iowa City, Iowa, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan Hospitals
Ann Arbor, Michigan, United States
RECRUITINGMayo Clinic - Rochester
Rochester, Minnesota, United States
RECRUITINGNorthwell Health/R.J. Zuckerberg Cancer Center
Lake Success, New York, United States
RECRUITING...and 7 more locations
Objective response rate (ORR)
Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria in Gastrointestinal Stromal Tumors (GIST). Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.
Time frame: 30 months
Duration of response (DOR)
Duration of response defined as the time from date of the first documentation of objective tumor response (CR or PR) based on RECIST v1.1 to the first documentation of either PD or death due to any cause, whichever occurs first.
Time frame: 30 months
Disease control rate (DCR)
Disease control rate is the proportion of subjects that experience confirmed complete response (CR), partial response (PR), or stable disease based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.
Time frame: 30 months
Time to response (TTR)
Time to response is defined as time from 1st dose of study treatment to date of 1st documentation of objective tumor response (CR or PR) based on RECIST v1.1.
Time frame: 30 months
Progression-free survival (PFS)
Progression-free survival is defined as the time from enrollment to the date of Progressive Disease (PD) based on RECIST v1.1 or death due to any cause, whichever occurs first. PFS at 6 months will also be characterized which indicates the proportion of subjects that experience progression within 6 months from time of enrollment.
Time frame: Up to 30 months
Overall survival (OS)
Evaluate efficacy of study treatment characterized by OS. Overall survival is defined as the time from start of treatment to death.
Time frame: Up to 30 months
Number of patients who experience treatment-emergent adverse advents, serious adverse events, and dose-limiting toxicities (Part 1)
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs), from first dose of study treatment to 28 days after last dose of study treatment.
Time frame: From enrollment to the end of treatment
Area under the curve (AUC)
Area under the concentration-time curve (AUC) of KQB198 in combination with imatinib.
Time frame: Up to 30 months
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) of KQB198 in combination with imatinib.
Time frame: Up to 30 months
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration (Tmax) of KQB198 in combination with imatinib.
Time frame: Up to 30 months
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