EUCTR2007-002725-74-GB进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •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 (<
- •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
排除标准
- •1. Active or uncontrolled autoimmune disease that may require corticosteroid
- •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
研究者
相似试验
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 ChemotherapyHormone refractory prostate cancerMedDRA version: 8.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerEUCTR2006-004571-36-GBCougar Biotechnology, Inc33
已完成
2 期
An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based ChemotherapyProstate CancerProstatic NeoplasmsNCT00485303Cougar Biotechnology, Inc.58
已完成
2 期
An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based ChemotherapyProstate NeoplasmsNCT00474383Cougar Biotechnology, Inc.47
进行中（未招募）
1 期
An Extended Study of CB7630 (Abiraterone Acetate) in Patients with Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy and Completed Clinical Study COU-AA-003EUCTR2008-002210-22-GBJanssen Oncology, Inc.
进行中（未招募）
1 期
An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients with Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001Hormone refractory prostate cancerMedDRA version: 14.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2006-006755-12-GBJanssen Oncology, Inc.