An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

NCT00485303 | Completed Phase 2 Results

• 3 other identifiers: CR016921COU-AA-0042007-002725-74
• Study Type: interventional
• Target: 58
• Locations: 2 countries
• Sites: 14

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).

Conditions

Prostatic Neoplasms; Prostate Cancer

Keywords

Prostatic Neoplasms; Prostate cancer; Abiraterone acetate; CB7630; Prednisone

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Prostate Specific Antigen (PSA) Response

  The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.

  Day 1 of each cycle (of 28 days each) up to Cycle 12

Secondary Outcomes (8)

• Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)

  Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months

• Radiographic Progression Free Survival (PFS)

  Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

• Overall Survival (OS)

  Every 3 months until death or up to 60 months

• Percentage of Participants With Objective Radiographic Response

  Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

• Time to PSA Progression

  Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)

Study Arms (1)

Abiraterone

EXPERIMENTAL

Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-days dosing cycle and will be continued until disease progression or unacceptable toxicity.

Drug: Abiraterone acetate; Drug: Prednisone

Interventions

Abiraterone acetate DRUG

Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.

Abiraterone

Prednisone DRUG

Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.

Also known as: CB7630

Abiraterone

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology
• Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel
• Documented prostate specific antigen (PSA) progression according to Prostate Specific Antigen Working Group (PSAWG) eligibility criteria with a PSA more than (\>) 5 nanogram per milliliter (ng/mL) or objective progression by Response Evaluation Criteria in Solid Tumors (RESIST) criteria
• Ongoing androgen deprivation with serum testosterone less than (\<) 50 nanogram per deciliter (ng/dL)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of less than equal to (\<=) 2 (Karnofsky Performance Status \>= 50 percent)

You may not qualify if:

• Active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy
• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
• Uncontrolled hypertension (high blood pressure)
• Hemoglobin \<=9.0 gram per deciliter (g/dL) without growth factor or transfusion support
• Abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function

Sponsors & Collaborators

• Cougar Biotechnology, Inc.: lead

Study Sites (14)

UCLA

Los Angeles, California, 90024, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Unknown Facility

San Francisco, California, United States

Location

John Hopkins

Baltimore, Maryland, 21205, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Masachussetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Hospital

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Unknown Facility

New York, New York, United States

Location

Royal Marsden Hospital

Sutton, United Kingdom

Location

Unknown Facility

Sutton, United Kingdom

Location

Related Publications (1)

• Danila DC, Anand A, Sung CC, Heller G, Leversha MA, Cao L, Lilja H, Molina A, Sawyers CL, Fleisher M, Scher HI. TMPRSS2-ERG status in circulating tumor cells as a predictive biomarker of sensitivity in castration-resistant prostate cancer patients treated with abiraterone acetate. Eur Urol. 2011 Nov;60(5):897-904. doi: 10.1016/j.eururo.2011.07.011. Epub 2011 Jul 14.

  PMID: 21802835 DERIVED

Related Links

• NATIONAL CANCER INSTITUTE
• PROSTATE CANCER

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; 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)

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

Results Point of Contact

• Title: Senior Director, Clinical Research
• Organization: Janssen Research & Development, 10990 Wilshire Blvd, Suite 1200, Los Angeles, California 90024

(310) 943-8040

Study Officials

• Cougar Biotechnology, Inc. Clinical Trial

  Cougar Biotechnology, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 12, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 2, 2013
• Results First Posted: June 17, 2013

Record last verified: 2013-06

Locations

US (12); GB (2)