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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

December 30, 2016

Primary Completion Date

June 30, 2021

Study Completion Date

October 31, 2026

Conditions
Prostate Cancer Metastatic
Interventions
DRUG

Apalutamide

"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"

DRUG

Abiraterone acetate

"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"

DRUG

Docetaxel

"Taxane cytotoxic chemotherapy with demonstrated survival benefit in those with advanced prostate cancer.~Dose: 75 mg/m2 Q3W"

DRUG

Prednisone

Dose: 5 mg BID

Trial Locations (2)

10065

Weill Cornell Medical College, New York

68130

GU Research Network/Urology Cancer Center, Omaha

All Listed Sponsors
collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER