Recruiting NCT06655246
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ziftomenib, imatinib mesylate.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Cancer, Gastrointestinal Stromal Neoplasm, Gastrointestinal Stromal Tumor, Malignant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1a/1b 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
Overview
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.
Interventions
- Drug ziftomenib
menin inhibitor - Drug imatinib mesylate
kinase inhibitor
Primary outcome measures
- Dose Escalation: Dose Limiting Toxicity (DLT) [Time frame: Cycle 1 (first 28 day cycle)]
- Descriptive statistics of Adverse Events (AEs) [Time frame: First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the participant is lost to follow-up, whichever comes first]
- Dose Expansion: Clinical benefit rate (CBR) [Time frame: Up to 2 years following start of treatment with ziftomenib]
Secondary outcome measures (12)
- Recommended Phase 2 Dose Determination and Dose Expansion: CBR [Time frame: Up to 2 years following start of treatment with ziftomenib]
- Overall Response Rate (ORR) [Time frame: Up to 2 years following start of treatment with ziftomenib]
- Progression Free Survival (PFS) [Time frame: Up to 2 years following start of treatment with ziftomenib]
- Duration of Response (DoR) [Time frame: Up to 2 years following start of treatment with ziftomenib]
- Overall Survival (OS) [Time frame: Up to 2 years following start of treatment with ziftomenib]
- Maximum plasma concentration (Cmax) [Time frame: Day 1 of each cycle; each cycle is 28 days]
- Time to maximum plasma concentration (Tmax) [Time frame: Day 1 of each cycle; each cycle is 28 days]
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC 0-last) [Time frame: Day 1 of each cycle; each cycle is 28 days]
- Area under the concentration-time curve over a dosing interval (AUC tau) [Time frame: Day 1 of each cycle; each cycle is 28 days]
- Maximum plasma concentration (Cmax) [Time frame: Day 1 of each cycle; each cycle is 28 days]
- Time to maximum plasma concentration (Tmax) [Time frame: Day 1 of each cycle; each cycle is 28 days]
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC 0-last) [Time frame: Day 1 of each cycle; each cycle is 28 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 32 centers
- University of Alabama at Birmingham — Birmingham
- Mayo Clinic Cancer Center — Phoenix
- University of California, San Diego — La Jolla
- University of Southern California — Los Angeles
- University Of California, Irvine — Orange
- Stanford Cancer Institute — Palo Alto
- UCLA Santa Monica Medical Center — Santa Monica
- University of Colorado Cancer Center — Aurora
- … and 24 more centers
Identifiers
NCT: NCT06655246 · KO-MEN-015