Overview

Selinexor as a Single Agent and in Combination With Imatinib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors.

Status:
Recruiting

Trial end date:
2022-12-01

Target enrollment:

Participant gender:

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

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Grupo Espanol de Investigacion en Sarcomas

Treatments:

Imatinib Mesylate