Active, not recruiting
Phase 1
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
Condition(s) studied
Prostatic NeoplasmsMetastatic Castration-Resistant Prostate Cancer
Investigational drug(s) / intervention(s)
Abiraterone AcetatePrednisoneJNJ-56021927
Abiraterone Acetate: Administered orally (by mouth) once daily in morning at a dose of 1000 mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
Prednisone: Administered orally twice a day at a dose of 5mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
JNJ-56021927: Administered orally once daily in morning at a dose of 240 mg starting on Day 8, Treatment Cycle 1 for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
Study summary
The purpose of this study is to investigate potential drug-drug interaction (DDI) between JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine safety of the combination and evaluate in a descriptive manner the efficacy in these participants. It will also, potentially provide dosing recommendations for abiraterone acetate in future studies when combined with JNJ-56021927.
Eligibility
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Documentation of metastatic disease
* Prostate cancer progression
* Surgically or medically castrated, with testosterone levels of less than (\<) 50 nanogram per deciliter (ng/dL)
* Adequate bone marrow and organ function
Exclusion Criteria:
* Known brain metastases
* Pathological finding consistent with small cell carcinoma of the prostate
* Administration of an investigational agent within 4 weeks of Treatment Cycle 1, Day 1
* Chemotherapy, or immunotherapy for the treatment of prostate cancer within 4 weeks of Treatment Cycle 1, Day 1
* Therapies that must be discontinued or substituted prior to Treatment Cycle 1, Day 1 include the following: Medications known to lower the seizure threshold; Herbal and non-herbal products that may decrease prostate specific antigen (PSA) levels (that is, saw palmetto, pomegranates or pomegranate juice); Medications known to induce drug metabolizing enzymes such as dexamethasone, rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.; and, potent inhibitors of CYP3A4 or CYP2C8
Primary outcome measure(s)
- Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of abiraterone — Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
The AUC (0-24) is area under the plasma concentration-time curve from time zero to time 24 hours.
- Maximum plasma concentration (Cmax) of abiraterone, prednisone and its metabolite prednisolone — Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
The Cmax is the maximum observed plasma concentration.
- Area Under the Plasma Concentration-time Curve From Time Zero to Time 12 Hours (AUC [0-12]) of prednisone and its metabolite prednisolone — Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
The AUC (0-12) is area under the plasma concentration-time curve from time zero to time 12 hours.
Trial sites (7)
| Facility | City | Region | Status |
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| — |
Los Angeles |
California |
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| — |
San Francisco |
California |
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Houston |
Texas |
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| — |
Vancouver |
British Columbia |
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| — |
Montreal |
Quebec |
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| — |
Rotterdam |
Netherlands |
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| — |
Sutton |
United Kingdom |
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