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A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

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ClinicalTrials.gov Identifier: NCT02227251
Recruitment Status : Recruiting
First Posted : August 28, 2014
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: Selinexor Phase 2

Detailed Description:
This is a multicenter, open-label Phase 2b study of the SINE compound, selinexor. A fixed 60mg dose of selinexor is given orally to patients with relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit. One hundred thirty patients with relapsed/refractory DLBCL who meet eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred. Patients will be followed until disease progression and/or death.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Study Start Date : November 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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.
Drug: Selinexor
Fixed milligram dose of 60 mg selinexor orally twice weekly.
Other Name: KPT-330




Primary Outcome Measures :
  1. Objective Response [ Time Frame: one year ]
    Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227251


Contacts
Contact: Michael Kauffman, MD, PhD (617) 658-0600 mkauffman@karyopharm.com
Contact: Sharon Shacham, PhD (617) 658-0600 sshacham@karyopharm.com

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Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
Study Director: Michael Kauffman, MD, PhD Karyopharm Therapeutics Inc

Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02227251     History of Changes
Other Study ID Numbers: KCP-330-009
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Karyopharm Therapeutics Inc:
Diffuse large B-cell Lymphoma
DLBCL
Karyopharm
KPT-330
selinexor

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin