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

NCT01424930 | Completed Phase 2 Results DMC

• 2 other identifiers: CR018715212082PCR2008
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Prostate Neoplasms; Prostate Cancer

Keywords

Metastatic castration-resistant prostate cancer; CRPC; Abiraterone Acetate; Prednisone; Food Safety

Outcome Measures

Primary Outcomes (1)

• 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

  AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.

  Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1

Secondary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of Abiraterone

  Day 7 and Day 14

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone

  Day 7 and Day 14

• Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)

  Day 7 and Day 14

Study Arms (2)

Abiraterone+prednisone (low-fat meal)

EXPERIMENTAL

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.

Drug: Abiraterone; Drug: Prednisone

Abiraterone+prednisone (high-fat meal)

EXPERIMENTAL

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.

Drug: Abiraterone; Drug: Prednisone

Interventions

Abiraterone DRUG

Participants will receive abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized low-fat meal and high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14.

Abiraterone+prednisone (high-fat meal); Abiraterone+prednisone (low-fat meal)

Prednisone DRUG

Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.

Abiraterone+prednisone (high-fat meal); Abiraterone+prednisone (low-fat meal)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

Study Sites (2)

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Senior Director
• Organization: Janssen R&D US

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen-Ortho, Canada Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 29, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 25, 2014
• Results First Posted: April 30, 2014

Record last verified: 2014-07

Locations

CA (2)