Phase 2
Completed N=25
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
Source: ClinicalTrials.gov NCT01424930 ↗Enrolled (actual)
25
Serious AEs
32.0%
Results posted
Apr 2014
Primary outcomePrimary: Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication — 0; 0 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication |
0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Abiraterone |
218; 196; 265; 342 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone |
2; 2; 2.5; 4.0 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) |
1271; 973; 1264; 1992 | — |
Eligibility Criteria
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 ( 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
Data sourced from ClinicalTrials.gov (NCT01424930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.