Clinical trial · Interventional
Phase 1 Study of Abiraterone Acetate in Castration-resistant Prostate Cancer
Phase 1 Study of JNJ-212082 (Abiraterone Acetate) in Patients With Castration-Resistant Prostate Cancer
NCT01186484CI-TRIAL-00030009completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess pharmacodynamics and safety of JNJ-212082 in order to select the recommended dose of JNJ-212082 for patients with castration resistant prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-212082 | Drug | Abiraterone Acetate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 001
- description
- JNJ-212082 250 mg 500 mg or 1000 mg once daily up to discontinuation for any reasons such as progression of the disease or up to the transition to extension study.
- interventionNames
- Drug: JNJ-212082
Primary outcomes (2)
- measure
- The pharmacodynamics (serum concentrations of corticosterone, testosterone, DHEA-S, 11-deoxycorticosterone)
- timeFrame
- At Days 1, 2, and 8 of Cycle 1
- measure
- The number of patients reporting adverse events as a measure of safety
- timeFrame
- 4 weeks
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate, but not with neuroendocrine differentiation or of small cell histology * No Prior cytotoxic chemotherapy (including estramustine) for the treatment of prostate cancer * Surgically or medically castrated, with testosterone levels of \< 0.5 ng/mL * PSA level of at least 2 ng/ml at Screening * PSA progression according to PCWG2 eligibility criteria or objective progression by RECIST criteria for patients with measurable disease after androgen deprivation Exclusion Criteria: * Surgery or local prostatic intervention within 4 weeks of the first dose. In addition, any clinically relevant sequelae from the surgery have not resolved prior to initial treatment * Radiotherapy, or immunotherapy within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks of administration prior to initial treatment * Known brain metastasis * Uncontrolled hypertension (systolic BP greater than 160 mmHg or diastolic BP greater than 95 mmHg) * Active or symptomatic viral hepatitis or chronic liver disease
References
Publications (1)
- DERIVEDMatsubara N, Uemura H, Fukui I, Niwakawa M, Yamaguchi A, Iizuka K, Akaza H. Phase-1 study of abiraterone acetate in chemotherapy-naive Japanese patients with castration-resistant prostate cancer. Cancer Sci. 2014 Oct;105(10):1313-20. doi: 10.1111/cas.12496. Epub 2014 Oct 4. PMID 25117615