Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT01986348
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    One cycle is 28 days (4 weeks).

Study Details

This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral selinexor in participants with recurrent gliomas.

Key Dates

Start date
Mar 3, 2014
Status verified
Jan 2023
Primary completion
Jan 23, 2020
Completion
Jan 23, 2020

Study Design

Enrollment
76 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Selinexor 60 mg and Surgery
    Participants who required surgery received up to 3 doses of oral selinexor tablets 60 milligrams (mg) twice weekly (BIW) on Day 1, Day 3 and between 2 and 48 hours prior to surgery, subsequently underwent surgery for resection of their tumor and resumed selinexor tablets 60 mg BIW after recovery, during Week 1 to 4 of each 4-week cycle, until progression of disease (PD) or development of unacceptable toxicities.
  • Experimental: Arm B: Selinexor 50 mg/m^2
    Participants who were not eligible for surgery received selinexor tablets 50 mg per square meter (mg/m\^2) BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
  • Experimental: Arm C: Selinexor 60 mg
    Participants who were not eligible for surgery received selinexor tablets 60 mg BIW during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.
  • Experimental: Arm D: Selinexor 80 mg
    Participants who were not eligible for surgery received selinexor tablets 80 mg once weekly (QW) during Week 1 to 4 of each 4-week cycle until PD or development of unacceptable toxicities.

Primary Outcome Measure

6-Month Progression-Free Survival (PFS) Rate [ Time Frame: From start of study treatment up to disease progression or death, whichever occurred first (assessed up to Month 6) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer Institute, Center for Neuro-OncologyBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Columbia University, Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-

Find similar trials in Boston, MA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Dana Farber Cancer Institute, Center for Neuro-Oncology· Boston, MAMassachusetts General Hospital· Boston, MAColumbia University, Herbert Irving Comprehensive Cancer Center· New York, NY

Related Studies