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

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT02314247
Phase
PHASE2
Status
Terminated

Conditions

  • Cutaneous T-cell Lymphoma (CTCL)
  • Peripheral T-cell Lymphoma (PTCL)

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-4 of each 4-week cycle (Protocol V.3.0). 20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-3 of each 4-week cycle (Protocol V.\<3.0). Number of Cycles: up to 12 but there is no maximal duration for treatment.

Study Details

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.

Key Dates

Start date
Feb 28, 2015
Status verified
Jan 2023
Primary completion
Jan 31, 2016
Completion
Feb 29, 2016

Study Design

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

Arms

  • Experimental: Selinexor
    60 mg dose (equivalent to \~35 mg/m²)

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. ]

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