Ziftomenib + Imatinib for GIST
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot have taken any prohibited medications, including investigational therapies, less than 14 days before starting the study.
What data supports the effectiveness of the drug combination Ziftomenib + Imatinib for GIST?
Imatinib has been shown to significantly change the treatment and prognosis of gastrointestinal stromal tumors (GISTs) by effectively targeting the disease, especially in cases that are intermediate- and high-risk, as well as locally advanced and metastatic. This suggests that combining it with another drug like Ziftomenib could potentially enhance its effectiveness.12345
Is the combination of Ziftomenib and Imatinib safe for treating GIST?
Imatinib, used for treating gastrointestinal stromal tumors (GIST), is generally well tolerated with most side effects being mild, such as muscle cramps and gastrointestinal symptoms. Severe side effects are rare and usually occur early in treatment. There is no specific safety data available for Ziftomenib in this context.16789
What makes the drug Ziftomenib + Imatinib unique for treating GIST?
Ziftomenib + Imatinib is unique because it combines two drugs that target different pathways involved in gastrointestinal stromal tumor (GIST) growth, potentially overcoming resistance seen with Imatinib alone. This combination may enhance the effectiveness of treatment by addressing multiple mechanisms that tumors use to survive.23101112
Eligibility Criteria
This trial is for adults with advanced GIST who have a specific mutation (KIT mutant) and whose disease got worse despite being treated with imatinib. They should be relatively active (ECOG ≤2), not pregnant, have at least one tumor that can be measured, good organ function, and recovered from previous treatments.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of ziftomenib in combination with imatinib to determine the dose limiting toxicity
Recommended Phase 2 Dose Determination
Determination of the recommended phase 2 dose based on safety, pharmacokinetics, and preliminary antitumor activity
Dose Expansion
Participants receive the recommended phase 2 dose to evaluate antitumor activity and overall survival
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Imatinib
- Ziftomenib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kura Oncology, Inc.
Lead Sponsor