Clinical trial · Interventional
A Safety Study of Abiraterone Acetate Administered in Combination With Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 1b Safety Study of Abiraterone Acetate (JNJ-212082) and Docetaxel in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCT01400555CI-TRIAL-00032174mCRPCcompletedPhase 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 evaluate the maximum safe dose of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Neoplasms | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cohort 1 | Drug | — | UNRESOLVED |
| Cohort 2 | Drug | — | UNRESOLVED |
| Cohort 3 | Drug | — | UNRESOLVED |
| Cohort 4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 001
- description
- Cohort 1 Docetaxel 60 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
- interventionNames
- Drug: Cohort 1
- type
- EXPERIMENTAL
- label
- 002
- description
- Cohort 2 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
- interventionNames
- Drug: Cohort 2
- type
- EXPERIMENTAL
- label
- 003
- description
- Cohort 3 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 1000 mg/day + prednisone 10 mg/day
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the prostate * Metastatic disease documented by bone, computed tomography (CT), or magnetic resonance image (MRI) scan * Surgical or medical castration with testosterone less than 50 ng/dL * Prostate cancer progression documented by 1 of the following: PSA progression according to Prostate Cancer Working Group 2 (PCWG2) criteria, radiographic progression by modified Response Evaluation Criteria in Solid Tumors (RECIST) or bone scan * Absolute neutrophil count \>1,500 cells/mm3 * Platelets \>100,000/µl * Hemoglobin \>=10.0 g/dL * Eastern Cooperative Group (ECOG) status score of \<=2. Exclusion Criteria: * Elevated liver function tests (LFTs): Serum bilirubin \>upper limit of normal (ULN), alanine (ALT) or aspartate (AST) aminotransferase \> 1.5 ULN concomitant with alkaline phosphatase \> 2.5 ULN * Small cell carcinoma of the prostate * Pulmonary or brain metastasis, liver metastasis is allowed if LFTs are not elevated * Pre-existing neuropathy or severe fluid retention * Prior cytotoxic chemotherapy for metastatic prostate cancer * Prior therapy with other CYP17 inhibitor(s) or investigational agent(s) targeting the androgen receptor for metastatic prostate cancer * Treatment of primary tumor within 4 weeks of Day 1 Week 1 with surgery, radiation, chemotherapy or immunotherapy * Use of investigational drug within 4 weeks of Day 1 Week 1 or current enrollment in an investigational drug or device study * Prior ketoconazole for prostate cancer * Recent history of ischemic heart disease, electrocardiogram (ECG) abnormalities, or atrial fibrillation.
References
Publications (1)
- DERIVEDHuang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35. PMID 22747660