Selinexor in Treating Patients With Abiraterone Acetate and/or Enzalutamide Refractory Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT02215161
Phase
PHASE2
Status
Terminated

Conditions

  • Castration Levels of Testosterone
  • Hormone-Resistant Prostate Cancer
  • Metastatic Prostate Carcinoma in the Soft Tissue
  • PSA Progression
  • Prostate Carcinoma Metastatic in the Bone
  • Stage IV Prostate Adenocarcinoma AJCC v7

Eligibility Criteria

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

Interventions

Study Details

This phase II trial studies selinexor in treating patients with prostate cancer that has spread to other parts of the body (metastatic), keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant), and did not respond to treatment (refractory) with abiraterone acetate and/or enzalutamide. Selinexor may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Sep 2, 2014
Status verified
May 2018
Primary completion
Feb 15, 2017
Completion
Apr 2, 2018

Study Design

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

Arms

  • Experimental: Treatment (selinexor)
    Patients receive selinexor PO on days 1 and 3 of weeks 1-3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Radiographic Progression Free Survival (rPFS) [ Time Frame: From study start up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94115-

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CA

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