Clinical trial NCT02314247: Efficacy and Safety Study of Selinexor in Relapsed or Refractory Peripheral T-cell Lymphoma or Cutaneous T-cell Lymphoma
Official title: Multi-center, Phase 2, Open-label Study of Efficacy and Safety of the Selective Inhibitor of Nuclear Export (SINE™) Selinexor (KPT-330) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) and Cutaneous T-cell Lymphoma (CTCL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Peripheral T-cell Lymphoma (PTCL)
Cutaneous T-cell Lymphoma (CTCL)
Keywords: PTCL
CTCL
Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma
Karyopharm
KPT-330
Selinexor
Lead sponsor: Karyopharm Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Enrolled patients will be given selinexor as an oral fixed 60 mg dose (equivalent to \~35 mg/m²) on Days 1 and 3 of Weeks 1-4 of each 4-week cycle (total 8 doses per cycle).

There is no maximum treatment duration. Patients will receive supportive therapy to mitigate selinexor side effects, as well as best supportive care (BSC).

Patients enrolled under Protocol Versions \<3.0 were to receive selinexor orally, at a fixed dose of 60 mg (equivalent to \~35 mg/m²) on Days 1 and 3 of Weeks 1-3 of each 4-week cycle (total of 6 doses per cycle). Selinexor was not taken during Week 4.

For all patients enrolled in this study (regardless of the protocol version) who continued onto Cycle 3 and forward, the dose was to be increased by 20 mg to 80 mg (administered on Days 1 and 3 of Weeks 1-4), only after consultation with the Sponsor's Medical Monitor.

Eligibility 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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 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.
measure: Best Overall Response: Complete Response (CR)
timeFrame: 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.
measure: Best Overall Response: Partial Response (PR)
timeFrame: 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.
measure: Best Overall Response: Stable Disease (SD)
timeFrame: 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.
measure: Best Overall Response: Progressive Disease (PD)
timeFrame: 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.
measure: Best Overall Response: Not Evaluable (NE)
timeFrame: 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.
Secondary outcomes:
measure: Duration of Stable Disease, Including Patients With Partial Response
timeFrame: Date of start of study treatment to date of progression. Patients without documented PD are censored on date of last radiologic assessment.
measure: Disease Control Rate (DCR)
timeFrame: 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.
measure: Progression Free Survival (PFS)
timeFrame: Study treatment start date to date of disease progression or date of death. Patients without documented PD are censored on date of last radiologic assessment.
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Concord Repatriation General Hospital (CRGH)
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Singapore
country: Singapore
facility: National Cancer Centre
Study officials:
References: