EUCTR2006-004571-36-GB进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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
研究者
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