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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02314247




Registration number
NCT02314247
Ethics application status
Date submitted
3/12/2014
Date registered
11/12/2014

Titles & IDs
Public title
Efficacy and Safety Study of Selinexor in Relapsed or Refractory Peripheral T-cell Lymphoma or Cutaneous T-cell Lymphoma
Scientific 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)
Secondary ID [1] 0 0
KCP-330-013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral T-cell Lymphoma (PTCL) 0 0
Cutaneous T-cell Lymphoma (CTCL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Selinexor

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


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
Best Overall Response: Complete Response (CR)
Timepoint [2] 0 0
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.
Primary outcome [3] 0 0
Best Overall Response: Partial Response (PR)
Timepoint [3] 0 0
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.
Primary outcome [4] 0 0
Best Overall Response: Stable Disease (SD)
Timepoint [4] 0 0
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.
Primary outcome [5] 0 0
Best Overall Response: Progressive Disease (PD)
Timepoint [5] 0 0
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.
Primary outcome [6] 0 0
Best Overall Response: Not Evaluable (NE)
Timepoint [6] 0 0
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 outcome [1] 0 0
Duration of Stable Disease, Including Patients With Partial Response
Timepoint [1] 0 0
Date of start of study treatment to date of progression. Patients without documented PD are censored on date of last radiologic assessment.
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
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 outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
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.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital (CRGH) - Concord
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2139 - St. Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment outside Australia
Country [1] 0 0
Singapore
State/province [1] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Karyopharm Therapeutics Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02314247