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
- Conditions
- HRPC (Hormone refractory prostate cancer) refractory to androgen deprivation and Docetaxel based chemotherapyMedDRA version: 9.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer
- Registration Number
- EUCTR2007-002725-74-GB
- Lead Sponsor
- Cougar Biotechnology, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Willing and able to provide written informed consent
2. Written Data Protection Consent has been obtained
3. Age = 18 years and male
4. Histologically or cytologically confirmed adenocarcinoma of the prostate, but
not with neuroendocrine differentiation or of small cell histology
5. Prior chemotherapy for prostate cancer with regimen(s) containing docetaxel.
Patients may have had up to two previous chemotherapy regimens
6. Documented PSA progression according to PSAWG eligibility criteria
(Attachment 1) with a PSA> 5 ng/mL
7. On-going androgen deprivation with serum testosterone < 50 ng/dL (<
2.0nM)
8. Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2
(Karnofsky Performance Status = 50%)
9. 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
10. Life expectancy > 12 weeks
11. Able to swallow the CB7630 whole as a tablet
12. Able to follow study instructions, accessible for treatment and follow-up, and
likely to complete all study requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Active or uncontrolled autoimmune disease that may require corticosteroid
therapy
2. Serious or uncontrolled co-existent non-malignant disease, including active and
uncontrolled infection
3. Uncontrolled hypertension
4. Hemoglobin = 9.0 g/dL without growth factor or transfusion support
5. Abnormal liver function tests consisting of any of the following:
Serum bilirubin > 1.5 x ULN
ALT > 2.5 x ULN
AST > 2.5 x ULN
6. Serum creatinine > 2.0 x UNL or a calculated creatinine clearance < 50 mL/min
7. Serum potassium < 3.5 mmol/L
8. Clinically significant heart disease as evidenced by a myocardial infarction in the
past twelve 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 two years prior to enrollment and
after consultation with a cardiologist to insure that the disease is stable
9. Abnormal electrocardiogram, including any finding which would interfere with
assessment of intervals (patients with long QT syndrome, bundle branch blocks
or hemiblocks are prohibited)
10. 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
11. History of adrenal insufficiency or hyperaldosteronism
12. History of gastrointestinal disorders (medical disorders or extensive surgery)
which may interfere with the absorption of the study medication
13. 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
dose/regimen
14. Surgery or local prostatic intervention within 30 days of the first dose In
addition, any clinically relevant sequelae from the surgery must have resolved
prior to Cycle 1 Day 1
15. Current enrollment in an investigational drug or device study or participation in
such a study within 30 days of Cycle 1 Day 1
16. Initiate bisphosphonate therapy or adjust bisphosphonate dose/regimen within 30 days of Cycle 1 Day 1
17. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method