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A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

Phase 2
18 Years
Not Enrolling
Prostate Neoplasms

Thank you

Trial Information

A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

This is an open-label study (identity of study drug will be known) to investigate the safety
and efficacy of abiraterone acetate in patients with prostate cancer who have failed taxane
(Docetaxel)-based chemotherapy. Abiraterone acetate 1000 mg will be administered orally (by
mouth) once daily after an overnight fast until disease progression, lack of disease
response after six 28-day cycles of treatment, or unacceptable toxicity is encountered.
Patients will be treated for up to 12 cycles. As of Protocol Amendment 2, all patients will
receive a concurrent low-dose glucocorticoid (such as prednisone/prednisolone). Efficacy and
safety will be monitored throughout the study.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate, but not
with neuroendocrine differentiation or of small cell histology

- Prior chemotherapy for prostate cancer with regimen(s) containing paclitaxel or

- Documented prostate-specific antigen (PSA) progression according to PSA Working Group
eligibility criteria with a PSA >5 ng/mL

- On-going androgen deprivation with serum testosterone <50 ng/dL (< 2.0nM)

- Serum potassium >=3.5 mmol/L

- Eastern Cooperative Oncology Group (ECOG) Performance Status of <=2 (Karnofsky
Performance Status >=50%)

- No history of adrenal insufficiency or hyperaldosteronism

- Any acute toxicities of prior chemotherapy, radiotherapy have resolved to a NCI CTCAE
(version 3) grade of <=1 (chemotherapy induced alopecia and grade-2 neuropathy are
excluded from this consideration)

- No radiotherapy, chemotherapy, or immunotherapy within 30 days of administration of
the Cycle 1 Day 1 (supportive care with glucocorticoid is not considered as an
immunotherapy; however, PSA progression must be documented under current

- No surgery or local prostatic intervention within 28 days of the first dose and any
clinically relevant sequelae from the surgery must have resolved prior to Cycle 1 Day

- Agrees to protocol-defined use of effective contraception

- Life expectancy >12 weeks

Exclusion Criteria:

- Active or uncontrolled autoimmune disease that may require corticosteroid therapy

- Serious or uncontrolled co-existent non-malignant disease, including active and
uncontrolled infection

- Uncontrolled hypertension

- Laboratory values not within protocol-defined parameters

- Clinically significant heart disease as evidenced by a myocardial infarction in the
past 12 months, severe or unstable angina, or New York Heart Association (NYHA) Class
III or IV heart disease (patients with a history of atherosclerotic vascular disease
requiring coronary or peripheral artery bypass surgery may be enrolled provided the
surgery occurred at least 2 years prior to enrollment and after consultation with a
cardiologist to insure that the disease is stable)

- Other malignancy within the previous 5 years other than basal cell or squamous cell
carcinomas of skin with a >30% probability of recurrence within 12 months

- History of gastrointestinal disorders (medical disorders or extensive surgery) which
may interfere with the absorption of the study medication

- Current enrollment in an investigational drug or device study or participation in
such a study within 30 days of Cycle 1 Day 1

- Condition or situation which, in the investigator's opinion, may put the patient at
significant risk, may confound the study results, or may interfere significantly with
patient's participation in the study

Type of Study:


Study Design:

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

Outcome Measure:

Prostate specific antigen (PSA) response

Outcome Description:

PSA decline >=50% according to Prostate Specific Antigen Working Group criteria

Outcome Time Frame:

Day 1 each cycle, End-of-Study visit

Safety Issue:


Principal Investigator

Cougar Biotechnology Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Cougar Biotechnology, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

August 2011

Related Keywords:

  • Prostate Neoplasms
  • Prostate neoplasms
  • Prostate cancer
  • Hormone refractory prostate cancer
  • Advanced prostate cancer
  • Failed androgen deprivation
  • CB7630
  • Abiraterone acetate
  • Docetaxel-based chemotherapy
  • Taxane-based chemotherapy
  • Neoplasms
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
UCSF Comprehensive Cancer Center San Francisco, California  94115