Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT02913196
Phase
PHASE1
Status
Completed

Conditions

  • Prostate Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
    Orally available, small molecule, nonsteroidal potent and selective antagonist of the androgen receptor. Cohort 1 dose: 120 mg QD Cohort 2 dose: 240 mg QD Cohort 3 dose: 180 mg QD
  • Abiraterone acetate — DRUG
    Abiraterone acetate is the prodrug of the active drug abiraterone. Once absorbed after oral administration, abiraterone acetate is rapidly converted to the active form, abiraterone. Dose: 1000 mg QD
  • Docetaxel — DRUG
    Taxane cytotoxic chemotherapy with demonstrated survival benefit in those with advanced prostate cancer. Dose: 75 mg/m2 Q3W
  • Prednisone — DRUG
    Dose: 5 mg BID

Study Details

This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate, docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer (mCRPC). This study is designed to determine the dose that apalutamide can be administered safely in combination with abiraterone acetate, docetaxel and prednisone.

Key Dates

Start date
Dec 30, 2016
Status verified
Apr 2026
Primary completion
Jun 30, 2021
Completion
Oct 15, 2025

Study Design

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

Arms

  • Experimental: All patients
    Apalutamide, 120 mg (cohort 1), 240 mg (cohort 2), 180 mg (cohort 3) Abiraterone Acetate 1000mg Prednisone 10mg Docetaxel 75 mg/m2

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLT) [ Time Frame: From the time of study drug administration till PSA progression or study completion (~36 months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
GU Research Network/Urology Cancer CenterOmahaNebraska68130-
Weill Cornell Medical CollegeNew YorkNew York10065-

Find similar trials in Omaha, NE

By research site
GU Research Network/Urology Cancer Center· Omaha, NEWeill Cornell Medical College· New York, NY

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