EUCTR2010-022064-12-CZ进行中（未招募）1 期
Randomized, Open Label, Multi-Center Study comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in Combination with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer not Pretreated with Chemotherapy - FIRSTANA
sanofi-aventis R&D0 个研究点目标入组 1,170 人开始时间: 2011年1月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,170
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.Histologically- or cytologically-confirmed prostate adenocarcinoma. 2.Metastatic disease. 3.Progressive disease while receiving hormonal therapy or after surgical castration documented 4.Effective castration (serum testosterone levels = 0.50 ng/mL) by orchiectomy and/or LHRH agonists or antagonist with or without anti-androgens.
- •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.Prior chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed > 3 years ago. Prior treatment with sipuleucel-T immunotherapy is allowed at the condition patient did not received prior chemotherapy. 2.Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Patients may be on biphosphonates prior to study entry. 3.Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 30% of bone marrow. 4.Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization. 5.Less than 18 years. 6.Eastern Cooperative Oncology Group (ECOG) performance status > 2. 7.History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease. 8.Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed = 5 years ago and from which the patient has been disease-free for = 5 years. 9.Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. 10.Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack. 11.Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event. 12.Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment. 13.Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or interfere with interpretation of study results or patients unable to comply with the study procedures. 14.Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study. 15.Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period. The definition of effective method of contraception” will be based on the investigator’s judgment. For patients enrolled in the United Kingdom, their partner (unless surgically sterile, post menopausal or for another reason have no chance of becoming pregnant) should use an effective means of contraception described hereafter: oral contraceptives or intra uterine device. Related to chemotherapy 16.History of hypersensitivity to docetaxel, or polysorbate 80. 17.Inadequate organ and bone marrow function as evidenced by: a.Hemoglobin <10.0 g/dL b.Absolute neutrophil count <1.5 x 109/L c.Platelet count < 100 x 109/L d.AST/SGOT and/or ALT/SGPT > 1.5 x ULN; e.Total bilirubin > 1.0 x ULN f.Serum Creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated either according to Cockcroft-Gault formula for patients younger than 65 years or, according to aMDRD formula for pat
研究者
相似试验
进行中（未招募）
1 期
Cabazitaxel versus Docetaxel both with Prednisone in Patients with Metastatic Castration Resistant Prostate CancerEUCTR2010-022064-12-SEsanofi-aventis R&D1,170
进行中（未招募）
1 期
Cabazitaxel versus Docetaxel both with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancermetastatic Castration Resistant Prostate cancerMedDRA version: 14.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022064-12-DEsanofi-aventis R&D1,170
进行中（未招募）
1 期
Cabazitaxel versus Docetaxel both with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancermetastatic Castration Resistant Prostate cancerMedDRA version: 14.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022064-12-PLsanofi-aventis R&D1,170
进行中（未招募）
不适用
Randomized, Open Label, Multi-Center Study comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in Combination with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer not Pretreated with Chemotherapy - FIRSTANAmetastatic Castration Resistant Prostate cancerMedDRA version: 14.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022064-12-ITsanofi-aventis R&D1,170
进行中（未招募）
1 期
Cabazitaxel versus Docetaxel both with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancermetastatic Castration Resistant Prostate cancerMedDRA version: 16.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022064-12-FIsanofi-aventis R&D1,170