Selinexor as a Single Agent and in Combination With Imatinib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 26
Summary
- Conditions
- Drug Toxicity
- Drug Use
- GIST
- Maximum Tolerated Dose
- Metastatic Adult Soft Tissue Sarcoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Phase Ib/II, single-arm, two-cohort, non-randomized, open-label, multicenter, national clinical trial, single agent, combinations productsMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 advan...
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) To evaluate the clinical benefit rate (CBR: CR+PR+ SD ? 16 wks) To evaluate progression free survival (PFS) To evaluate overall survival (OS) To evaluate the objective response rate (ORR) To evaluate the safety profile according to CTCAE 4.03 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.
Tracking Information
- NCT #
- NCT04138381
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Cesar Serrano, MD Hospital Vall d´Hebron