Selinexor in Initial or Refractory and/or Relapsed Richter's Transformation

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT02138786
Phase
PHASE2
Status
Terminated

Conditions

  • Richter's Transformation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • selinexor — DRUG
    * 60 mg dose twice weekly, on Days 1 and 3 of weeks 1-4 of each 4-week cycle; dose may be increased to 80 mg after Cycle 1 unless clinically contraindicated (Protocol V.5.0). * 60 mg dose twice weekly on Days 1 and 3 of weeks 1-3 of each 4-week cycle; dose may be increased to 80 mg at Cycle 3 Day 1 unless clinically contraindicated (Protocol V.4.0). * 60 mg/m² dose, based on BSA, twice weekly, on Days 1 and 3 of weeks 1-3 of each 4-week cycle (Protocol V. 3.0). * 60 mg/m² dose, based on BSA, twice weekly, on Days 1 and 3 of weeks 1-4 of each 4-week cycle (Protocol V. \< 3.0).

Study Details

This is a multi-center, phase 2, single arm, open-label study of oral selinexor monotherapy in patients with Richter's Transformation, arising in the setting of prior chronic lymphocytic leukemia (CLL), after at least one chemo-immunotherapy regimen for CLL.

Key Dates

Start date
Nov 14, 2014
Status verified
Jan 2023
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: selinexor
    oral tablets * 10 mg \& 25 mg (bottled); or * 20 mg (blister pack)

Primary Outcome Measure

Percentage of Participants With Overall Response (Overall Response Rate) [ Time Frame: Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death. ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724-
City of Hope National Medical CenterDuarteCalifornia91010-
University of California-Los AngelesSanta MonicaCalifornia90404-
Winship Cancer Institute / Emory UniversityAtlantaGeorgia30322-
Weill Cornell Medical CollegeNew YorkNew York10065-
Ohio State University Comprehensive Cancer CenterColumbusOhio43202-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Tucson, AZ

By research site
University of Arizona Cancer Center· Tucson, AZCity of Hope National Medical Center· Duarte, CAUniversity of California-Los Angeles· Santa Monica, CAWinship Cancer Institute / Emory University· Atlanta, GAWeill Cornell Medical College· New York, NYOhio State University Comprehensive Cancer Center· Columbus, OH

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