Vanderbilt Clinical Trials

A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Purpose

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

Gastrointestinal Stromal Tumor (GIST)
Gastrointestinal Stromal Cancer
Gastrointestinal Stromal Neoplasm
Gastrointestinal Stromal Tumor, Malignant
Gastrointestinal Stromal Cell Tumors

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Documented diagnosis of advanced/metastatic KIT-mutant GIST. - Documented disease progression on imatinib as current or prior therapy. - Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening. - At least 1 measurable lesion per RECIST v1.1 modified for GIST. - Negative pregnancy test for participants of childbearing potential. - Adequate organ function per protocol requirements. - Resolution of all clinically significant toxicities from prior therapy to <Grade 1 (or participant baseline) within 1 week before the first dose of study intervention. - Participant, or legally authorized representative, must be able to understand and provide written informed consent before the first screening procedure.

Exclusion Criteria

Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation. - History of prior or current cancer that has potential to interfere with obtaining study results. - Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives before the first dose of study intervention. - Active central nervous system metastases. - Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease. - Mean corrected QT interval (QTcF) greater than 470ms. - Left ventricular ejection fraction (LVEF) <50%. - Major surgery within 2 weeks before the first dose of study intervention. - Is pregnant or breastfeeding. - Gastrointestinal abnormalities that may impact taking study intervention by mouth. - Actively bleeding, excluding hemorrhoidal or gum bleeding.

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Dose Escalation	Ziftomenib plus imatinib	Drug: ziftomenib menin inhibitor Drug: imatinib mesylate kinase inhibitor Other names: Gleevec
Experimental Recommended Phase 2 Dose Determination	Ziftomenib plus imatinib	Drug: ziftomenib menin inhibitor Drug: imatinib mesylate kinase inhibitor Other names: Gleevec
Experimental Dose Expansion	Ziftomenib plus imatinib	Drug: ziftomenib menin inhibitor Drug: imatinib mesylate kinase inhibitor Other names: Gleevec

Recruiting Locations

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

More Details

Status: Recruiting
Sponsor: Kura Oncology, Inc.

Study Contact

Kura Medical Information 844-KURAONC
844-587-2662
medinfo@kuraoncology.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.