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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms, Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Prostate Specific Antigen (PSA) Response

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Cougar Biotechnology, Inc. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Cougar Biotechnology, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

CR016921

NCT ID:

NCT00485303

Start Date:

June 2007

Completion Date:

October 2011

Related Keywords:

  • Prostatic Neoplasms
  • Prostate Cancer
  • Prostatic Neoplasms
  • Prostate cancer
  • Abiraterone acetate
  • CB7630
  • Prednisone
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Fountain Valley, California  92708
Albany, New York  12208
Baltimore, Maryland  21287
Boston, Massachusetts  
UCLALos Angeles, California  90095
Beth Israel HospitalBoston, Massachusetts  02215
John HopkinsBaltimore, Maryland  21205
Masachussetts General Hospital Cancer CenterBoston, Massachusetts  02114