Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With… (NCT02913196) | Clinical Trial Compass
CompletedPhase 1
Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
United States16 participantsStarted 2016-12-30
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Histologically or cytologically confirmed adenocarcinoma of prostate
✓. Documented progressive metastatic CRPC based on at least one of the following criteria:
✓. PSA progression according to Prostate Cancer Working Group 3 (PCWG3) criteria
✓. Objective radiographic progression in soft tissue, according to modified Response Evaluation Criteria In Solid Tumors (RECIST) or bone scans
✓. ECOG performance status of 0-2
✓. 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
✓. Age \>18 years
✓. Patients must have normal organ and marrow function as defined below:
Exclusion criteria
✕. Liver Function
✕. If total bilirubin is \>1.5 x ULN (NOTE: in subjects with Gilbert's syndrome, if total bilirubin is \>1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
✕. Alanine (ALT) or aspartate (AST) aminotransferase \>1.5xULN (or \>5xULN for subject with liver metastasis) concomitant with alkaline phosphatase \>2.5xULN (or \>5xULN for subjects with bone or liver metastases) or
✕
What they're measuring
1
Number of participants with dose limiting toxicities (DLT)
Timeframe: From the time of study drug administration till PSA progression or study completion (~36 months)
Trial details
NCT IDNCT02913196
SponsorWeill Medical College of Cornell University
. Alanine (ALT or aspartate (AST) aminotransferase \>2.5xULN (or \>5xULN for subjects with liver metastasis
✕. Use of investigational drugs (including vaccines) or implantation of invasive medical device ≤4 weeks or \<5 half-lives of Cycle 1, Day 1 or current enrollment in investigational drug or device study
✕. Prior exposure to apalutamide. Prior exposure to abiraterone acetate and/or other CYP17 inhibitors, enzalutamide is allowed (but not preferred) only during the dose escalation period
✕. Prior chemotherapy for advanced prostate cancer. Prior chemotherapy for any other disease within 3 years