Clinical trial

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)

ID

Name

KCP-330-013

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.

Trial arms

Trial start

2015-02-01

Estimated PCD

2016-01-01

Trial end

2016-02-01

Status

Terminated

Phase

Early phase I

Treatment

Selinexor

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.

Arms:

Selinexor

Other names:

KPT-330

Size

16

Primary endpoint

Overall Response Rate (ORR)

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.

Best Overall Response: Complete Response (CR)

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.

Best Overall Response: Partial Response (PR)

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.

Best Overall Response: Stable Disease (SD)

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.

Best Overall Response: Progressive Disease (PD)

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.

Best Overall Response: Not Evaluable (NE)

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.

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}

Updated at

2023-01-26

1 organization

1 product

2 indications

Product

Indication

Peripheral T-cell Lymphoma (PTCL)

Indication

Cutaneous T-cell Lymphoma

Organization

Karyopharm Therapeutics