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

Sponsor
Grupo Espanol de Investigacion en Sarcomas
Study ID
NCT04138381
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Drug Toxicity
  • Drug Use
  • GIST
  • Maximum Tolerated Dose
  • Metastatic Adult Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    oral selinexor given once weekly (Cohort A), oral selinexor given BIW (Cohort B)
  • Imatinib — DRUG
    imatinib 400 mg, once daily (Cohort A)

Study Details

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

Key Dates

Start date
Aug 16, 2019
Status verified
Mar 2023
Primary completion
Apr 16, 2023
Completion
Apr 16, 2023

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: selinexor as a single agent and in combination with imatinib
    This is a single-arm, two-cohort, open label phase Ib/II 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 en expansion phase (II) testing for safety and preliminary evidence of antitumor activity * Cohort B: single-agent, fixed selinexor dose in the same target population

Primary Outcome Measure

Maximum tolerated dose (MTD) for the use of Imatinib in combination with Selinexor [ Time Frame: 32 months ]

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