Efficacy and Safety Study of Selinexor in Relapsed or Refractory Peripheral T-cell Lymphoma or Cutaneous T-cell Lymphoma
NCT ID: NCT02314247
Last Updated: 2023-01-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2015-02-28
2016-02-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Selinexor
60 mg dose (equivalent to \~35 mg/m²)
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Karyopharm Therapeutics Inc
INDUSTRY
Responsible Party
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Locations
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Concord Repatriation General Hospital (CRGH)
Concord, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Cabrini Hospital
Malvern, Victoria, Australia
National Cancer Centre
Singapore, , Singapore
Countries
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Other Identifiers
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KCP-330-013
Identifier Type: -
Identifier Source: org_study_id
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