Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
A Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Sponsor: Weill Medical College of Cornell University + Janssen Scientific Affairs, LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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)
Secondary Endpoints
Change in the number of subjects with prostate-specific antigen (PSA) response
Change in PSA response
Change in the time to PSA progression
Eligibility Criteria
Inclusion Criteria 1. Histologically or cytologically confirmed adenocarcinoma of prostate 2. Documented progressive metastatic CRPC based on at least one of the following criteria: 1. PSA progression according to Prostate Cancer Working Group 3 (PCWG3) criteria 2. Objective radiographic progression in soft tissue, according to modified Response Evaluation Criteria In Solid Tumors (RECIST) or bone scans 3. ECOG performance status of 0-2 4. Have serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy 5. Age \>18 years 6. Patients must have normal organ and marrow function as defined below: 1. Absolute neutrophil count \>1,500/cells/mm3 2. Hemoglobin ≥ 9 g/dL 3. Platelet count \>100,000 x 109/microliter 4. Serum creatinine \<1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault 5. Serum albumin ≥3.…
Read full criteria on CT.gov →✦ Analyst Commentary
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