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In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Ziftomenib plus imatinib |
|
| Recommended Phase 2 Dose Determination | Experimental | Ziftomenib plus imatinib |
|
| Dose Expansion | Experimental | Ziftomenib plus imatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ziftomenib | Drug | menin inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: Dose Limiting Toxicity (DLT) | Rate of DLTs per dose level | Cycle 1 (first 28 day cycle) |
| Descriptive statistics of Adverse Events (AEs) | Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 | First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the participant is lost to follow-up, whichever comes first |
| Dose Expansion: Clinical benefit rate (CBR) | CBR is the rate of participants achieving complete response (CR), partial response (PR), or stable disease (SD), assessed per Response Criteria in Solid Tumors (RECIST) v1.1 modified for GIST | Up to 2 years following start of treatment with ziftomenib |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose Determination and Dose Expansion: CBR | CBR is CR + PR + SD assessed per RECIST v1.1 modified for GIST | Up to 2 years following start of treatment with ziftomenib |
| Overall Response Rate (ORR) |
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Key Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kura Medical Information 844-KURAONC | Contact | 844-587-2662 | medinfo@kuraoncology.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| imatinib mesylate | Drug | kinase inhibitor |
|
|
ORR is CR + PR assessed per RECIST v1.1 modified for GIST
| Up to 2 years following start of treatment with ziftomenib |
| Progression Free Survival (PFS) | Assessed per RECIST v1.1 modified for GIST | Up to 2 years following start of treatment with ziftomenib |
| Duration of Response (DoR) | Defined as the time from the first response (CR or PR assessed per RECIST v1.1 modified for GIST) to disease progression or death from any cause | Up to 2 years following start of treatment with ziftomenib |
| Overall Survival (OS) | Defined as the time from first dose of ziftomenib or imatinib (whichever is dosed first) until death from any cause | Up to 2 years following start of treatment with ziftomenib |
| Maximum plasma concentration (Cmax) | Cmax of ziftomenib | Day 1 of each cycle; each cycle is 28 days |
| Time to maximum plasma concentration (Tmax) | Tmax of ziftomenib | Day 1 of each cycle; each cycle is 28 days |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC 0-last) | AUC 0-last of ziftomenib | Day 1 of each cycle; each cycle is 28 days |
| Area under the concentration-time curve over a dosing interval (AUC tau) | AUC tau of ziftomenib | Day 1 of each cycle; each cycle is 28 days |
| Maximum plasma concentration (Cmax) | Cmax of imatinib | Day 1 of each cycle; each cycle is 28 days |
| Time to maximum plasma concentration (Tmax) | Tmax of imatinib | Day 1 of each cycle; each cycle is 28 days |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC 0-last) | AUC 0-last of imatinib | Day 1 of each cycle; each cycle is 28 days |
| Area under the concentration-time curve over a dosing interval (AUC tau) | AUC tau of imatinib | Day 1 of each cycle; each cycle is 28 days |
| Mayo Clinic Cancer Center |
| Recruiting |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| University of California, San Diego | Recruiting | La Jolla | California | 92093 | United States |
| University of Southern California | Recruiting | Los Angeles | California | 90033 | United States |
| University Of California, Irvine | Recruiting | Orange | California | 92868 | United States |
| Stanford Cancer Institute | Recruiting | Palo Alto | California | 94304 | United States |
| UCLA Santa Monica Medical Center | Recruiting | Santa Monica | California | 90404 | United States |
| University of Colorado Cancer Center | Recruiting | Aurora | Colorado | 80045 | United States |
| Sarah Cannon Research Institute | Recruiting | Denver | Colorado | 80220 | United States |
| Yale University School of Medicine | Recruiting | New Haven | Connecticut | 06511 | United States |
| Mayo Clinic Cancer Center | Recruiting | Jacksonville | Florida | 32224 | United States |
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Harvard University | Recruiting | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic Cancer Center | Recruiting | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan-Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University Health System | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
| Sarah Cannon Research Institute | Recruiting | Dallas | Texas | 75230 | United States |
| University of Texas | Recruiting | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center | Recruiting | San Antonio | Texas | 78229 | United States |
| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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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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