SHIP (Selinexor in Hormone Insensitive Prostate Cancer)

Part of paid clinical trials in Houston, Texas.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT02146833
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Comparison of different dosages and dosing schedules of drug.

Study Details

This is an open-label, Phase 2 clinical study of the oral Selective Inhibitor of Nuclear Export (SINE) selinexor (KPT-330) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Key Dates

Start date
May 31, 2014
Status verified
Jan 2023
Primary completion
Apr 1, 2016
Completion
Apr 1, 2016

Study Design

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

Arms

  • Experimental: Selinexor Dosing Regimen 1
    80 mg twice weekly for 4 weeks (8 doses per 28-day cycle)
  • Experimental: Selinexor Dosing Regimen 2
    80 mg once weekly for 4 weeks (4 doses per 28-day cycle)
  • Experimental: Selinexor Dosing Regimen 3
    60 mg twice weekly for 2 weeks, then 1 week off (4 doses per 21-day cycle)

Primary Outcome Measure

Percentage of Participants With Overall Clinical Benefit Response (CBR) [ Time Frame: At 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
M.D. Anderson Cancer Center· Houston, TX

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