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 1

• Conditions: Hormone refractory prostate cancer; MedDRA version: 8.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancer

• Registration Number: EUCTR2006-004571-36-GB
• Lead Sponsor: Cougar Biotechnology, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-16
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 33

Inclusion Criteria

1. Willing and able to provide written informed consent
2. Written Authorization for Use and Release of Health and Research Study Information (USA sites only) or Data Protection Consent (European sites only) 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 paclitaxel or docetaxel.
6. Documented PSA progression according to PSAWG eligibility criteria with a PSA> 5 ng/mL.
7. On-going androgen deprivation with serum testosterone < 50 ng/dL (< 2.0nM)
8. Serum potassium = 3.5 mmol/L
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2 (Karnofsky Performance Status = 50%)
10. No history of adrenal insufficiency or hyperaldosteronism
11. 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.
12. 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 dose/regimen
13. No surgery or local prostatic intervention within 28 days of the first dose. In addition, any clinically relevant sequelae from the surgery must have resolve
prior to Cycle 1 Day 1.
14. Life expectancy > 12 weeks
15. Able to swallow the CB7630 whole as a capsule
16. 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

Exclusion Criteria

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
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. 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.
8. 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.
9. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication.
10. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day 1
11. 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.
12. Patients who have partners of childbearing potential who are not willing to use a
method of birth control with adequate barrier protection as determined to be
acceptable by the principal investigator and sponsor during the study and for 13
weeks after last study drug administration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified