Clinical trial NCT00485303: An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Official title: A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Prostate Cancer
Keywords: Prostatic Neoplasms
Prostate cancer
Abiraterone acetate
CB7630
Prednisone
Lead sponsor: Cougar Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2007-06-12
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: This is an open-label (all people know the identity of the intervention), single-arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy. Abiraterone acetate oral tablet will be administered as a total dose of 1000 milligram (mg) orally (by mouth) once daily after an overnight fast and prednisone/prednisolone will be administered as 5 mg oral tablet twice daily. Participants will be enrolled and treated up to 12 cycles (or longer, if they have not progressed and continue to benefit from treatment). The study will consist of 3 parts: Screening (14 days), Open-label Treatment; and follow-up (up to 60 months). Participants will be evaluated primarily for prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Prostate Specific Antigen (PSA) Response
timeFrame: Day 1 of each cycle (of 28 days each) up to Cycle 12
Secondary outcomes:
measure: Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)
timeFrame: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months
measure: Radiographic Progression Free Survival (PFS)
timeFrame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
measure: Overall Survival (OS)
timeFrame: Every 3 months until death or up to 60 months
measure: Percentage of Participants With Objective Radiographic Response
timeFrame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
measure: Time to PSA Progression
timeFrame: Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)
measure: Time to Radiographic Progression
timeFrame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
measure: Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
timeFrame: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months
measure: Percentage of Participants With Clinical Benefit
timeFrame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
state: California
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
facility: Masachussetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Hospital
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
state: New York
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
city: Sutton
country: United Kingdom
Study officials:
affiliation: Cougar Biotechnology, Inc.
name: Cougar Biotechnology, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.