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Trial Title:
A Study of Ziftomenib, an Oral Menin Inhibitor, in Combination with Imatinib in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)
NCT ID:
NCT06655246
Condition:
Gastrointestinal Stromal Tumor (GIST)
Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract
Gastrointestinal Stromal Cancer
Gastrointestinal Stromal Neoplasm
Gastrointestinal Stromal Tumor, Malignant
Gastrointestinal Stromal Cell Tumors
Conditions: Official terms:
Neoplasms
Gastrointestinal Stromal Tumors
Imatinib Mesylate
Conditions: Keywords:
Gastrointestinal Stromal Tumor
Gastrointestinal Stromal Cancer
Gastrointestinal Stromal Neoplasm
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ziftomenib
Description:
menin inhibitor
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Arm group label:
Recommended Phase 2 Dose Determination
Intervention type:
Drug
Intervention name:
imatinib mesylate
Description:
kinase inhibitor
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Arm group label:
Recommended Phase 2 Dose Determination
Other name:
Gleevec
Summary:
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Documented diagnosis of advanced or metastatic KIT mutant GIST.
- Documented disease progression on imatinib therapy as current or prior treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at
screening.
- At least 1 measurable lesion per mRECIST.
- Negative pregnancy test for female patients of childbearing potential.
- Adequate organ function per protocol requirements.
- Resolution of all clinically significant toxicities from prior therapy to ≤Grade 1
(or patient baseline) within 1 week prior to the first dose of study drug.
- Participant, or legally authorized representative, must be able to understand and
provide written informed consent prior to the first screening procedure.
Key Exclusion Criteria:
- Diagnosis of non-KIT mutation or a T670X KIT mutation-driven GIST.
- History of prior or currently has cancer which 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 prior to 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 prior to the first dose of study intervention.
- Is pregnant or lactating.
- Gastrointestinal abnormalities that may impact taking study intervention by mouth.
- Actively bleeding, excluding hemorrhoidal or gum bleeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 2025
Completion date:
December 2028
Lead sponsor:
Agency:
Kura Oncology, Inc.
Agency class:
Industry
Source:
Kura Oncology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06655246
