Efficacy and Safety Study of Selinexor in Relapsed or Refractory Peripheral T-cell Lymphoma or Cutaneous T-cell Lymphoma

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, multi-center, open-label phase 2 study of the SINE™ compound selinexor given orally to patients with relapsed or refractory PTCL or CTCL.

Approximately 60 patients with relapsed or refractory PTCL or CTCL who meet the eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karyopharm Therapeutics Inc; Karyopharm Therapeutics, Inc

Criteria

Inclusion Criteria:

• ECOG performance status of ≤2.

• Relapsed or refractory disease to at least one prior systemic regimen.

• Measurable disease: according to International Working Group (IWG) guidelines for all patients with PTCL and according to CTCL Response in Skin consensus criteria for all patients with CTCL.

• Objective, documented evidence of disease progression on study entry.

Exclusion Criteria:

• Known active central nervous system (CNS) lymphoma.

• Active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation.

• Unable to swallow tablets or malabsorption syndrome, disease significantly affecting gastrointestinal function.