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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02227251




Registration number
NCT02227251
Ethics application status
Date submitted
12/08/2014
Date registered
26/08/2014
Date last updated
17/12/2018

Titles & IDs
Public title
A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Scientific title
Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Secondary ID [1] 0 0
KCP-330-009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma 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 (KPT-330) - 60 mg dose of Selinexor, orally twice weekly on Days 1 and 3 (e.g., Monday and Wednesday or Tuesday and Thursday, etc.) of Weeks 1, 2, and 3 of each four week (28 day) cycle.


Treatment: Drugs: Selinexor
Fixed milligram dose of 60 mg selinexor orally twice weekly.

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

Outcomes
Primary outcome [1] 0 0
Objective Response - Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG)
Timepoint [1] 0 0
one year

Eligibility
Key inclusion criteria
- Age =18 years

- Eastern Cooperative Oncology Group (ECOG) performance status of = 2

- Pathologically confirmed de novo DLBCL

- Objective, documented evidence of disease progression on study entry

- Have previously received at least 2 but no more than 5 previous systemic regimens for
the treatment of DLBCL

- Have measurable disease

- For patients whose most recent anti-DLBCL therapy induced a PR or CR, at least 60 days
must have elapsed since the end of that therapy. For all other patients, at least 14
weeks must have elapsed since their most recent systemic anti-DLBCL therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma
(HL+NHL) or DLBCL transformed from diseases other than indolent NHL

- Must not be eligible for high-dose therapy with autologous stem cell transplantation
rescue

- Primary mediastinal (thymic) large B-cell lymphoma (PMBL)

- Known central nervous system (CNS) lymphoma

- Active Hepatitis B or C infection

- Known human immunodeficiency virus (HIV) infection

- Unable to swallow tablets, patients with malabsorption syndrome, or any other GI
disease or GI function that could interfere with absorption of study treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Liverpool Hospital, Ingham Institute of Medical Research - Liverpool
Recruitment hospital [3] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [4] 0 0
Icon Cancer Care - South Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Ashford Cancer Centre - Kurralta Park
Recruitment hospital [7] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
Epworth Hospital - East Melbourne
Recruitment hospital [9] 0 0
St. Vincent's Melbourne - Fitzroy
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3001 - East Melbourne
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment outside Australia
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Washington
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Leoben
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Linz
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Vienna
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Plymouth

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

Ethics approval
Ethics application status

Summary
Brief summary
A multicenter, open-label Phase 2b study of selinexor (KPT-330) in patients with
relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit.
Trial website
https://clinicaltrials.gov/show/NCT02227251
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Kauffman, MD, PhD
Address 0 0
Karyopharm Therapeutics Inc
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

No data has been provided for results reporting
Summary results
Other publications