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Selinexor as Single Agent and With Imatinib in Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (SeliGIST) — SeliGIST  

Drug Use Clinical Trial

Official title:
A Multicenter, Phase Ib/II Trial of Selinexor as a Single Agent and in Combination With Imatinib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GISTs)

Clinical Trial 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

Clinical Trial Description

Clinical Study Objectives: Primary clinical study objective Cohort A: 1.- To determine the maximum tolerated dose (MTD) and recommended phase II doses (RP2D) of selinexor in combination with imatinib among unresectable and/or metastatic GIST patients with prior failure to at least imatinib for advanced/metastatic disease. Cohort B: 1. To evaluate the clinical benefit rate (CBR: CR+PR+SD ≥ 16 wks) Secondary clinical study objectives (both cohorts A and B) 1. To evaluate the clinical benefit rate (CBR: CR+PR+ SD ≥ 16 wks) 2. To evaluate progression free survival (PFS) 3. To evaluate overall survival (OS) 4. To evaluate the objective response rate (ORR) 5. To evaluate the safety profile according to CTCAE 4.03 6. To compare PFS on selinexor and imatinib and on selinexor in monotherapy with PFS on last prior anti-cancer therapy. Translational Study Objective - To explore the relationship between GIST genotype and CBR with selinexor and imatinib, and selinexor as single-agent Pharmacokinetics Study Objective - To measure the plasma concentration of imatinib and selinexor at limited timepoints specificed in schedule of assessment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04138381
Study type Interventional
Source Grupo Espanol de Investigacion en Sarcomas
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date August 16, 2019
Completion date April 16, 2023
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