Spots Global Cancer Trial Database for Selinexor as Single Agent and With Imatinib in Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (SeliGIST)

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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)

Study ID: NCT04138381

Conditions

Maximum Tolerated Dose

GIST

Metastatic Adult Soft Tissue Sarcoma

Drug Toxicity

Drug Use

Interventions

Selinexor

Imatinib

Study Description

Brief 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

Detailed 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.