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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02227251
Ethics application status
Date submitted
12/08/2014
Date registered
28/08/2014

Titles & IDs
Public title
Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Scientific title
A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Secondary ID [1] 0 0
2014-001977-15
Secondary ID [2] 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
Treatment: Drugs - Selinexor
Treatment: Drugs - Selinexor

Experimental: Part 1: Selinexor 60 mg - Participants received fixed dose of 60 mg selinexor orally, twice weekly (BIW) on Days 1 and 3 (e.g., Monday and Wednesday or Tuesday and Thursday, etc.) of Weeks 1-4 of each four week (each cycle of 28 days) cycle (total of 8 doses per cycle).

Experimental: Part 2: Arm A-Selinexor 40 mg - Participants received selinexor 40 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles (28 days) until disease progression (total of 8 doses per cycle).

Experimental: Part 2: Arm B-Selinexor 60 mg - Participants received selinexor 60 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles) for 2 cycles (each cycle of 28 days) followed by 60 mg once weekly (QW) in the subsequent cycles until disease progression (total of 8 doses per cycle).


Treatment: Drugs: Selinexor
Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral

Treatment: Drugs: Selinexor
Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral

Treatment: Drugs: Selinexor
Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Overall Response Rate (ORR)
Timepoint [1] 0 0
One year
Primary outcome [2] 0 0
Part 2: Overall Response Rate (ORR) Based on Lugano Criteria
Timepoint [2] 0 0
From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
Secondary outcome [1] 0 0
Part 1: Duration of Response (DOR)
Timepoint [1] 0 0
From time of first response until disease progression or death (maximum of 1 year from Part 1 randomization)
Secondary outcome [2] 0 0
Part 1: Disease Control Rate (DCR)
Timepoint [2] 0 0
From initial response until disease progression or death (maximum of 1 year from Part 1 randomization)
Secondary outcome [3] 0 0
Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [3] 0 0
From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
Secondary outcome [4] 0 0
Part 1: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status
Timepoint [4] 0 0
From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
Secondary outcome [5] 0 0
Part 2: Duration of response (DOR)
Timepoint [5] 0 0
From time of first response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
Secondary outcome [6] 0 0
Part 2: Disease control rate (DCR)
Timepoint [6] 0 0
From initial response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
Secondary outcome [7] 0 0
Part 2: Overall Response Rate (ORR) Based on Modified Lugano Criteria
Timepoint [7] 0 0
From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
Secondary outcome [8] 0 0
Part 2: Number of Participants with Treatment-emergent Adverse Events
Timepoint [8] 0 0
From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
Secondary outcome [9] 0 0
Part 2: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status
Timepoint [9] 0 0
From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)

Eligibility
Key inclusion criteria
Inclusion Criteria (Parts 1 and 2):

* Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first screening procedure.
* Age greater than or equal to (=) 18 years.
* ECOG performance status of less than or equal to (=) 2.
* Participants should have estimated life expectancy of greater than (>) 3 months at study entry.
* Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
* Participants must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL including (i) at least 1 course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case other active agents such as etoposide, bendamustine, or gemcitabine must have been given) and (ii) at least 1 course of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Participants who were considered ineligible for standard multi-agent immunochemotherapy must have received at least 2 and no more than 5 prior treatment regimens including at least 1 course of anti-CD20 antibodies and must be approved by the Medical Monitor. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.
* Female participants of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception for 3 months after their last dose of medication. Male participants must use a reliable method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 3 months following the last dose.

Part 1 additional inclusion criteria:

* For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other participants, at least 14 weeks (98 days) must have elapsed since the end of their most recent systemic anti-DLBCL therapy. . Palliative localized radiation within the therapy-free interval is allowed. Non-chemotherapy maintenance will not be considered anti DLBCL therapy, and therefore is allowed during the therapy-free interval.
* Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
* Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is >1.5 centimeter (cm), regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is >1.0. Lymph nodes =1.0 by =1.0 will not be considered abnormal for relapse or PD.

Part 2 additional inclusion criteria:

• At least 3 weeks (21 days) must have elapsed since the end of participant's most recent systemic anti-DLBCL therapy (prior to Cycle 1 Day 1). Palliative localized radiation within the therapy-free interval is allowed.Non-chemotherapy maintenance will not be considered anti-DLBCL therapy, and therefore is allowed during the therapy-free interval.

• Adequate hematopoietic function: (i) Hemoglobin =10.0 grams per deciliters (g/dL) within 14 days of starting therapy (participant may receive red blood cell [RBC] transfusion within 14 days).

(ii) Absolute neutrophil count =1000 cells/millimeter (mm^3) (use of granulocyte growth factors prior to and during the study is acceptable).

(iii) Platelet count =100,000/mm^3 within 14 days of starting therapy (use of platelet growth factors prior to and during the study is acceptable).

* Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is >1.5 cm, regardless of the short axis. Extranodal lesion should be considered abnormal if the long axis is >1.0 cm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria (Parts 1 and 2):

* Participants who are pregnant or lactating.
* Primary mediastinal (thymic) large B-cell lymphoma (PMBL)
* Participants must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (Investigator must provide detailed documentation for ineligibility).
* Participants who have not recovered to Grade =1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy.
* Major surgery within 2 weeks of first dose of study treatment.
* Participants with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections.
* Psychiatric illness or substance use that would prevent the participant from giving informed consent or being compliant with the study procedures.
* Any of the following laboratory abnormalities:

(i) A circulating lymphocyte count of >50,000/L. (ii) Hepatic dysfunction: bilirubin >2.0 times the upper limit of normal (ULN) (except participants with Gilbert's syndrome: total bilirubin of >3*ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 times ULN. In participants with known liver involvement of their DLBCL, AST and ALT >5*ULN.

(iii) Severe renal dysfunction: estimated creatinine clearance of <30 mL/min, measured in 24-hour urine or calculated using the formula of Cockroft and Gault [(140-Age)*Mass (kg)/(72*creatinine mg/dL); multiply by 0.85 if female].

* Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety.
* Participants with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation.
* Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals on Cycle 1 Day 1; however, prophylactic use of these agents is acceptable even if parenteral.
* Participants unable to swallow tablets, participants with malabsorption syndrome, or any other gastrointestinal disease or gastrointestinal dysfunction that could interfere with absorption of study treatment.

Part 1 additional exclusion criteria:

* For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR: Radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids <60 days or <14 weeks prior to Cycle 1 Day 1.
* Known central nervous system lymphoma or meningeal involvement.
* DLBCL with mucosa-associated lymphoid tissue [MALT] lymphoma, composite lymphoma (Hodgkin's lymphoma+NHL), or DLBCL transformed from diseases other than indolent NHL.
* Unstable cardiovascular function:

(i) Symptomatic ischemia, or (ii) Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block /right bundle branch block will not be excluded), or (iii) Congestive heart failure of New York Heart Association Class =3, or (iv) Myocardial infarction within 3 months.
* Participants with a BSA <1.4 m^2 as calculated per Dubois 1916 or Mosteller 1987.
* Any of the following laboratory abnormalities:

(i) Absolute neutrophil count (ANC) <1000 cells/mm^3 or platelet count <75,000/mm^3 during screening and on Cycle 1 Day 1. Use of granulocyte-stimulating factors and platelet growth factors prior to and during the study is acceptable.

(ii) Hematopoietic dysfunction: hemoglobin < 10.0 g/dL within 14 days of and including Cycle 1 Day 1 and/or patients receiving red blood cell (RBC) transfusion within 14 days of and including Cycle 1 Day 1.

* Participants who have been committed to an institution by official or judicial order.
* Participants with dependency on the Sponsor, Investigator or study site.

Part 2 additional exclusion criteria:

* Participants with active HBV, HVC, or HIV infections. Participants with active HBV are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 International units per milliliters (IU/mL) prior to first dose of study treatment. Participants with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard. Participants with HIV who have CD4+T-cell counts =350 cells/microliter (mcL), negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year are allowed.
* Known active central nervous system lymphoma or meningeal involvement. Participants with a history of CNS disease treated into remission may be enrolled.
* DLBCL with MALT lymphoma, composite lymphoma (Hodgkin's lymphoma + NHL), DLBCL arising from CLL (Richter's transformation), or high-grade B-cell lymphoma.
* Received strong cytochrome P450 3A (CYP3A) inhibitors =7 days prior to Day 1 dosing or strong CYP3A inducers =14 days prior to Day 1 dosing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2027
Actual
Sample size
Target
244
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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United States of America
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Graz
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Innsbruck
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Leoben
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Linz
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Vienna
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Kerala
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Odisha
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Punjab
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Tamil Nadu
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West Bengal
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Lódz
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Serbia
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Belgrade
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Serbia
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Nis
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Serbia
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Sremska Kamenica
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Spain
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Badalona
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Barcelona
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Madrid
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Pamplona
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Salamanca
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Spain
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Sevilla
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United Kingdom
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Gloucestershire
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Hampshire
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London
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Middlesex
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Yorkshire
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Cambridge
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Liverpool
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Manchester
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Oxford
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United Kingdom
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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
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
Karyopharm Medical Information
Address 0 0
Country 0 0
Phone 0 0
(888) 209-9326
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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 not provided in https://clinicaltrials.gov/study/NCT02227251