Clinical trial · Interventional
A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer
An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Castration-Resistant Prostate Cancer
NCT01424930CI-TRIAL-00015217completedPhase 2Results postedClinicalTrials.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 establish the safety profile of oral (by mouth) abiraterone acetate and oral prednisone following short-term administration after standardized low-fat or high-fat meals to patients with metastatic (spreading) 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone | Drug | Abiraterone | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abiraterone+prednisone (low-fat meal)
- description
- Participants will receive abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
- interventionNames
- Drug: Abiraterone
- Drug: Prednisone
- type
- EXPERIMENTAL
- label
- Abiraterone+prednisone (high-fat meal)
- description
- Participants will receive abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
- interventionNames
- Drug: Abiraterone
- Drug: Prednisone
Primary outcomes (1)
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 imaging (MRI) scan * Surgical or medical castration with testosterone less than 50 ng/dL (\< 2.0 nM) * Prostate-specific antigen (PSA) or radiographic progression documented by assessments specified in study protocol * Platelets \>100,000/µl * Hemoglobin \>=9.0 g/dL * Liver function tests (LFTs): Serum bilirubin \< 1.5 x ULN; AST or ALT \< 2.5 x ULN; Eastern Cooperative Oncology Group (ECOG) status score of \<=2 Exclusion Criteria: * Small cell carcinoma of the prostate * Known brain metastasis, chronic liver disease with elevated LFTs * Prior cytotoxic chemotherapy for metastatic prostate cancer * Treatment of prostate cancer within 30 days of Day 1 Cycle 1 with surgery, radiation, chemotherapy or immunotherapy * Use of investigational drug within 30 days of Day 1 Cycle 1 or current enrollment in an investigational drug or device study * Recent history of ischemic heart disease, Electrocardiogram (ECG) abnormalities or atrial fibrillation * Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated * Chronic medical condition requiring a higher dose of corticosteroid than prednisone 5 mg twice daily
References
Publications (0)
Data not yet available
No reference posted for this study.