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 : Active, not recruiting
First Posted : August 28, 2014
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma||Drug: Selinexor||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)|
|Actual Study Start Date :||November 2014|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Selinexor (KPT-330)
Fixed milligram dose of 60 mg selinexor orally, twice weekly on Days 1 and 3 (e.g., Monday and Wednesday or Tuesday and Thursday, etc.) of Weeks 1-4 of each four week (28 day) cycle (total of 8 doses per cycle).
Fixed milligram dose of 60 mg selinexor orally twice weekly.
Other Name: KPT-330
- Objective Response [ Time Frame: one year ]Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG)
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
|Study Director:||Michael Kauffman, MD, PhD||Karyopharm Therapeutics Inc|