Selinexor as Single Agent and With Imatinib in Metastatic and/or Unresectable Gastrointestinal St… (NCT04138381) | Clinical Trial Compass
UnknownPhase 1/2
Selinexor as Single Agent and With Imatinib in Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (SeliGIST)
Spain30 participantsStarted 2019-08-16
Plain-language summary
This is a single-arm, two cohort, open label phase I/II clinical trial studying the combination of oral imatinib 400 mg, once daily, and oral selinexor given once weekly (Cohort A); and single-agent oral selinexor 60 mg BIW (Cohort B). The study will consist of:
* Cohort A: an initial escalation phase (Ib) evaluating increasing doses of selinexor in combination with fixed doses of imatinib administered in repeated 28-day cycles in advanced/metastatic, imatinib-resistant GIST patients, followed by an expansion phase (II) testing for safety and preliminary evidence of antitumor activity
* Cohort B: single-agent, fixed selinexor dose in the same target population
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years at the time of study entry.
✓. Histologically confirmed metastatic and/or unresectable GIST. Patients must demonstrate prior failure to at least imatinib. Any number of previous therapies for GIST is allowed.
✓. Failure of imatinib is defined as disease progression after ≥ 6 months of treatment with imatinib for advanced/metastatic disease. Exception to this rule is GIST patients with documented KIT or PDGFRA mutations.
✓. Measurable disease per modified RECIST 1.1.
✓. ECOG performance status 0 to 2.
✓. Adequate hematopoietic function (within 7 days prior to enrollment):
✓. Hemoglobin ≥ 9.0 g/dL (90 g/L).
✓. Absolute neutrophil count ≥ 1000/mm3.
Exclusion criteria
✕. Cohort A: Intolerance to first-line treatment imatinib 400mg daily.
✕
What they're measuring
1
Maximum tolerated dose (MTD) for the use of Imatinib in combination with Selinexor
Timeframe: 32 months
2
Clinical benefit rate (CBR) for the use of selinexor in monotherapy
. Use of any approved tyrosine kinase inhibitors or investigational agents within 1 week or 5 half-lives of the agent, whichever is shorter, prior to receiving study drugs.
✕. Participants who have had radiotherapy within 4 weeks prior to study entry.
✕. Major surgery or significant traumatic injury within 4 weeks prior to study entry.
✕. Presence of symptomatic or uncontrolled brain or central nervous system metastases.
✕. Known or suspected allergy or hypersensitivity to the selinexor, imatinib or any of its components.
✕. Patient has a history of another primary malignancy that has been diagnosed or required therapy within 1 year prior to the first dose of study drug (The following are exempt from the 1-year limit: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site.)
✕. Unstable cardiovascular function: • Symptomatic ischemia, or • Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded), or • Congestive heart failure (CHF) NYHA Class ≥ 3, or • Myocardial infarction (MI) within 3 months. • Left ventricular ejection fraction \< 40 %. • Hypertension \> 140 mm Hg systolic or \> 90 mm Hg diastolic with or without antihypertensive therapy.