Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT02227251
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
  • Selinexor — DRUG
    Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
  • Selinexor — DRUG
    Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral

Study Details

A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit.

Key Dates

Start date
Nov 30, 2014
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
244 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Part 1: Overall Response Rate (ORR) [ Time Frame: One year ]

Locations (23)

FacilityCityStateZIPSite coordinators
UACC ArizonaTucsonArizona85704-
University of California San FranciscoSan FranciscoCalifornia--
University of California Los Angeles (UCLA)Santa MonicaCalifornia90404-
Boca Raton Cancer Research Medical CenterPlantationFlorida--
Robert H. Lurie Comprehensive Cancer Center/Northwestern UniversityChicagoIllinois--
University of ChicagoChicagoIllinois60637-
Norton Cancer InstituteLouisvilleKentucky40241-
Dana Farber Cancer InstituteBostonMassachusetts--
Tufts Medical CenterBostonMassachusetts--
Lahey ClinicBurlingtonMassachusetts--
University of Massachusetts Medical SchoolWorcesterMassachusetts--
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey--
Clinical Research AllianceLake SuccessNew York--
New York Presbyterian Hospital/ Cornell Medical CollegeNew YorkNew York10065-
Stony Brook University HospitalStony BrookNew York11794-
Gabrail Cancer CenterCantonOhio44718-
Cleveland Clinic FoundationClevelandOhio44195-
University Hospitals Seidman Cancer CenterClevelandOhio--
University of OklahomaOklahoma CityOklahoma--
Greenville Hospital SystemGreenvilleSouth Carolina29605-
MD AndersonHoustonTexas77030-
Swedish Cancer InstituteSeattleWashington98104-
Virginia Mason Hospital & Medical CenterSeattleWashington--

Find similar trials in Tucson, AZ

By research site
UACC Arizona· Tucson, AZUniversity of California San Francisco· San Francisco, CAUniversity of California Los Angeles (UCLA)· Santa Monica, CABoca Raton Cancer Research Medical Center· Plantation, FLRobert H. Lurie Comprehensive Cancer Center/Northwestern University· Chicago, ILUniversity of Chicago· Chicago, IL

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