Actively Recruiting
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Led by Kura Oncology, Inc. · Updated on 2026-02-05
157
Participants Needed
32
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of advanced or metastatic KIT-mutant gastrointestinal stromal tumor (GIST)
- Documented disease progression on imatinib as current or prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at screening
- At least 1 measurable lesion according to RECIST v1.1 modified for GIST
- Negative pregnancy test for participants who can become pregnant
- Adequate organ function as defined by the study protocol
- All significant toxicities from prior therapy resolved to less than Grade 1 or baseline within 1 week before first dose
- Ability to understand and sign written informed consent before screening
You will not qualify if you...
- GIST diagnosis without a KIT mutation or with a T670X KIT mutation
- History of other cancers that could interfere with study results
- Use of prohibited medications or investigational therapy within 14 days or 5 half-lives before first dose
- Active metastases in the central nervous system
- Uncontrolled illnesses including cardiac disease defined by the protocol
- Mean corrected QT interval (QTcF) over 470ms
- Left ventricular ejection fraction (LVEF) below 50%
- Major surgery within 2 weeks before first dose
- Pregnancy or breastfeeding
- Gastrointestinal problems affecting oral medication intake
- Active bleeding except minor bleeding like hemorrhoids or gums
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 32 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Mayo Clinic Cancer Center
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
4
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
5
University Of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
6
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Actively Recruiting
7
UCLA Santa Monica Medical Center
Santa Monica, California, United States, 90404
Actively Recruiting
8
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Sarah Cannon Research Institute
Denver, Colorado, United States, 80220
Actively Recruiting
10
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Actively Recruiting
11
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
Actively Recruiting
12
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
13
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
14
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
15
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
16
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
17
Harvard University
Boston, Massachusetts, United States, 02215
Actively Recruiting
18
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
19
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Actively Recruiting
20
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
21
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
22
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
23
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
24
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
25
Temple University Health System
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
26
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
27
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
28
Sarah Cannon Research Institute
Dallas, Texas, United States, 75230
Actively Recruiting
29
University of Texas
Houston, Texas, United States, 77030
Actively Recruiting
30
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Actively Recruiting
31
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
32
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
K
Kura Medical Information 844-KURAONC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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