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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KQB198 in Combination with Imatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KQB198 | Drug | Oral KQB198 |
| |
| Imatinib (Gleevec) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 months |
| Disease control rate (DCR) |
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Inclusion Criteria
All Participants:
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kumquat Clinical Development | Contact | 858-214-2700 | kumquatstudies@kumquatbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States | |
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| Drug |
Oral Imatinib |
|
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. |
| 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. | 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. | 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. | 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. | 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. | Up to 30 months |
| Maximum plasma concentration (Cmax) | Maximum plasma concentration (Cmax) of KQB198 in combination with imatinib. | Up to 30 months |
| Time to maximum plasma concentration (Tmax) | Time to maximum plasma concentration (Tmax) of KQB198 in combination with imatinib. | Up to 30 months |
| Mayo Clinic - Jacksonville |
| Recruiting |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
| University of Iowa Health Care | Recruiting | Iowa City | Iowa | 52242 | United States |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| University of Michigan Hospitals | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic - Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| Northwell Health/R.J. Zuckerberg Cancer Center | Recruiting | Lake Success | New York | 11042 | United States |
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
| UT MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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