EUCTR2005-000635-15-GB进行中（未招募）1 期
Randomized, multicentre, prospective, two-arm, open-label Phase II study to investigate the efficacy and safety of two ZK219477 i.v. infusions (3-hour infusion of 16mg/m2 versus 0.5-hour infusion of 16mg/m2) in patients with recurrent ovarian cancer progressing during, or within 6 months of the end of platinum-based chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
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. Females aged =18 years
- •2. Histologically proven cancer of any of the following types:
- •- Epithelial ovarian cancer
- •- Peritoneal cavity cancer
- •- Fallopian tube cancer
- •3. Suitability of response assessment by the following:
- •- Measurable disease according to modRECIST, or
- •- CA-125 levels = 2 times upper limit of normal (ULN) within 2 weeks prior to the
- •first infusion
- •4. WHO performance status 0-1
- •5. Up to 2 previous chemotherapies; the most recent chemotherapy must have been
- •a platinum-containing therapy
- •6. Progression of measurable disease or symptomatic relapse during or within 6 months of
- •previous therapy (elevated CA-125 levels alone are insufficient for inclusion)
- •7. Time period since prior therapy:
- •- Prior radiotherapy: = 4 weeks
- •- Prior chemotherapy: = 4 weeks
- •- Prior immunotherapy: = 3 weeks
- •8. Adequate recovery from previous surgery, radiation, and chemotherapy (excluding alopecia)
- •9. Adequate function of major organs and systems
- •- Nervous system:
- •- No peripheral neuropathy = Grade 2
- •- No altered mental status
- •- Hematopoietic:
- •- Hemoglobin = 9 g/dL
- •- Absolute neutrophil count = 1,500/mm3
- •- Platelet count = 100,000/mm3
- •- Hepatic:
- •- Bilrubin within normal range
- •- AST/ALT = 5 x ULN
- •- Creatinine = 1.5 x ULN
- •- Cardiovascular:
- •- No symtomatic congestive heart failure
- •- No unstable angina pectoris
- •- No arrhythmia needing continuous treatment
- •- No other uncontrolled concurrent illness
- •10. Survival expectation = 3 months
- •11. written informed consent
- •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. More than 2 previous chemotherapies
- •2. Prior treatment with epothilones
- •3. Use of any investigational drug within 4 weeks before start of study treatment or
- •inadequate recovery from any toxic effects of such therapy
- •4. Previous radiation to the whole pelvis
- •5. Symptomatic brain metastases requiring whole-brain irradiation
- •6. Active infection
- •7. Any concomitant malignancy; the following exceptions are allowed;
- •- Non-melanoma skin cancer
- •- Carcinoma in situ of the cervix
- •- Malignancy with definitive treatment = 5 years ago without relapse
- •8. Mixed mesodermal tumor (MMT)
- •9. Prior hormone therapy for any malignancy within 1 month
- •10. Childbearing potential
- •11. Any conditions that in the opinion of the investigator could affect the compliance
- •with the study protocol
研究者
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