EUCTR2006-002205-31-FR进行中（未招募）1 期
Phase II Study of Dasatinib (BMS-354825) for Androgen-Deprived Progressive Prostate Cancer+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 2.0 dated 15-Aug-06)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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) Signed written informed consent according to institutional guidelines
- •2) Target population
- •a) Men = 18 years of age
- •b) Histologically or cytologically proven advanced prostate carcinoma
- •c) Metastatic disease documented by transaxial imaging or radionuclide bone scan.
- •d) Progressive disease based on PSA with a minimum of 3 consecutive rising levels, with an interval of > 1 week between each determination. The last determination must have a minimal value of 5 ng/mL and be determined within two weeks prior to registration.
- •3) Castrate levels of serum testosterone (< 30 ng/dL) determined within two weeks prior to starting treatment.
- •4) Subjects who have received an antiandrogen as part of their prior hormonal therapy must have shown progression of disease off of the antiandrogen prior to enrollment. The first of the three consecutive PSA measurements confirming progression should be dated at least 6 weeks after bicalutamide withdrawal and 4 weeks for other antiandrogens. Subjects who have never received antiandrogens should not begin antiandrogens during the study period.
- •5) At least 6 weeks must have elapsed for isotope therapy (12 weeks for Strontium-89 or immunotherapy), prior to beginning protocol therapy.
- •6) At least 4 weeks must have elapsed from major surgery.
- •7) Toxicities related to prior therapy must either have returned to CTC Grade 1, baseline or deemed irreversible.
- •8) Adequate organ function as defined by the following laboratory tests:
- •a) Hepatic enzymes (AST, ALT), Total bilirubin all CTC Grade 0-1
- •b) Serum Calcium = the lower limit of normal
- •c) Serum Potassium, Magnesium, and Phosphate all CTC Grade 0-1
- •d) Creatinine CTC Grade 0-2
- •e) Hemoglobin, Neutrophil count, Platelets, PT, PTT all CTC Grade 0-1
- •9) ECOG performance status 0-2 (see Protocol Appendix 1).
- •10) Life expectancy at least 3 months.
- •11) Subject must be available for follow-up.
- •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
- •Sex and Reproductive Status
- •2) Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period and for at least 12 weeks after completion of study medication
- •Target Disease Exceptions
- •3) Symptomatic CNS metastases
- •Medical History and Concurrent Diseases
- •4) Medical condition which could significantly increase the risk of toxicity, including:
- •a) Clinically-significant coagulation or platelet function disorder
- •b) Infection requiring intravenous antibiotics
- •c) Ongoing or recent gastrointestinal bleeding
- •d) Clinically-significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia within 6 months, prolonged QTc>450 msec., Ejection Fraction (EF) < 40% or major conduction abnormality (unless a cardiac pacemaker is present)
- •e) Requirement for prohibited concomitant therapy (for details, see Protocol section 6.4.1).
- •f) Pleural or pericardial effusion of any grade.
- •5) Any prior or ongoing anti-neoplastic medical therapy or immunotherapy for prostate cancer other than primary androgen deprivation agents
- •6) Any other concurrent malignancy other than in situ non-melanomatous carcinoma of skin. History of malignancy other than prostate cancer that has been in complete
- •remission >5 years is acceptable.
- •7) Inability to take or absorb oral medication for any reason
- •8) Inability to understand the potential risks and provide informed consent
- •Prohibited Therapies and/or Medications
- •9) Bisphosphonate use may not commence within 3 weeks of study entry. Subjects with current bisphosphonate use fulfilling study entry criteria may continue bisphosphates during study.
- •10) See Protocol section 6.4.1 for specific details:
- •a) potent CYP3A4 inhibitors
- •b) QTc prolonging agents strongly associated with Torsades de Pointes arrhythmia
- •Other Exclusion Criteria
- •11) Prisoners or subjects who are compulsorily detained
研究者
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