A Phase Ia/Ib Study of the Safety, Pharmacokinetics, and Antitumor Activity of the Oral Menin Inhibitor Ziftomenib in Combination with Imatinib in Patients with Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure
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.
Eligibility
Documented biopsy-proven diagnosis of advanced or metastatic KIT mutant GIST
Documented disease progression on imatinib therapy (either current or prior treatment)
At least 1 measurable lesion per mRECIST guidelines
Adequate organ function
Negative pregnancy for female subjects of childbearing potential
Key
Clinically-diagnosed non-KIT mutation or T670X KIT mutation-driven GIST
Received prohibited medication, including investigational therapy, within 14 days or 5 drug half-lives prior to 1st dose of study intervention
Active central nervous system metastases
Uncontrolled intercurrent illness, which includes but is not limited to cardiac disease
Gastrointestinal abnormalities which may impact receiving oral study intervention
Received major surgery within 2 weeks of 1st dose of study intervention
Interested in Participating in this Trial?
Thank you for your interest with our team.
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Privacy Policy
University of California, Irvine - Study Information Sheet
UCI Center for Clinical Research Potential Participant Database
Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research
In the instance of parental permission, “You” refers to “Your child.”
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