Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
- Conditions
- Prostate Cancer Metastatic
- Interventions
- Registration Number
- NCT02913196
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
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.
- Detailed Description
Subjects are enrolled in up to three 3-6-subject cohorts and are administered combination (apalutamide, abiraterone acetate and docetaxel plus prednisone) according to a dose-escalation schedule. The first dose of docetaxel infusion begins on Day 1 Cycle 1. Daily oral apalutamide, abiraterone acetate plus twice-daily oral prednisone begins on Day 1 Cycle 1. Docetaxel 1-hour infusions are administered intravenously every 3 weeks (Q3W), preceded by oral dexamethasone. While a subject is receiving chemotherapy, a treatment cycle is defined as 21 days. Dose limiting toxicity (DLT) determination is based on toxicities observed within the initial 2 cycles defined as 6 weeks. DLT will be assessed before the start of the third docetaxel infusion. Once a combination dose is determined to be safe (i.e. no more than 2 of 6 subjects experience DLT), the next cohort will enroll. Subjects remain at their allocated combination dose until the maximum tolerated dose (MTD) is determined.
The primary objective is to determine a safe dose combination of apalutamide plus abiraterone acetate, docetaxel, prednisone in subjects with mCRPC.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All patients Apalutamide Apalutamide, 120 mg (cohort 1), 240 mg (cohort 2), 180 mg (cohort 3) Abiraterone Acetate 1000mg Prednisone 10mg Docetaxel 75 mg/m2 All patients Abiraterone acetate Apalutamide, 120 mg (cohort 1), 240 mg (cohort 2), 180 mg (cohort 3) Abiraterone Acetate 1000mg Prednisone 10mg Docetaxel 75 mg/m2 All patients Docetaxel Apalutamide, 120 mg (cohort 1), 240 mg (cohort 2), 180 mg (cohort 3) Abiraterone Acetate 1000mg Prednisone 10mg Docetaxel 75 mg/m2 All patients Prednisone Apalutamide, 120 mg (cohort 1), 240 mg (cohort 2), 180 mg (cohort 3) Abiraterone Acetate 1000mg Prednisone 10mg Docetaxel 75 mg/m2
- Primary Outcome Measures
Name Time Method Number of participants with dose limiting toxicities (DLT) From the time of study drug administration till PSA progression or study completion (~36 months) Dose limiting toxicities will be measured by using the Common Terminology Criteria for Adverse Events or CTCAE version 4.0 which uses a grading scale from 1-5.
- Secondary Outcome Measures
Name Time Method Change in the number of subjects with prostate-specific antigen (PSA) response Starting after 12 weeks, at the beginning of Week 4 of combination therapy with docetaxel, apalutamide, abiraterone acetate plus prednisone until PSA progression or study completion (~36 months) Change in PSA response At the start of treatment until PSA progression or study completion (~36 months) PSA response will be captured through blood sample collection and radiographic scans
Change in the time to PSA progression At the start of treatment until PSA progression or study completion (~36 months) PSA progression will be determined by protocol-specific/modified Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
Change is radiographic progression-free survival Images will be collected at baseline, 12 weeks and at end of study, an average of 100 months Radiographic progression will be determined via scans metric of CT, MRI and Bone scans
Change in CellSearch circulating tumor cells (CTC) enumration Collected at baseline, 12 weeks and at end of study, an average of 100 months CTCs will be collected via blood sample collection
Trial Locations
- Locations (2)
Weill Cornell Medical College
🇺🇸New York, New York, United States
GU Research Network/Urology Cancer Center
🇺🇸Omaha, Nebraska, United States