EUCTR2005-003216-30-DE进行中（未招募）不适用
Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy, safety and tolerability of 4 regimes with 3 doses of ZK 219477 (16 and 12 mg/m² body surface area as 3-hour infusion or 22 mg/m² body surface area as 30-minute or 3-hour infusion) in patients with metastatic breast cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
- 入组人数
- 120
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
- Female
入选标准
- •1. Females aged >/= 18 years
- •2. Histologically proven (at diagnosis), metastatic breast cancer
- •3. At least 1 unidimensionally measurable lesion (suitable for modRECIST
- •evaluation)
- •4. Performance status: WHO 0-1
- •5. Progression of disease following a maximum of two previous steps of
- •chemotherapy, including treatments in an adjuvant or neoadjuvant setting
- •6. No previous taxane or vinca alkaloid treatment
- •7. No more than 1 non cytotoxic therapy (biologic agents)
- •8. No radiotherapy, chemotherapy, or immune/biologic therapy within 3 weeks prior
- •to first dose of ZK 219477
- •9. Adequate recovery from previous surgery, radiation, and chemotherapy
- •10. Adequate function of major organs and systems
- •Hematopoietic:
- •- Hemoglobin >/= 10 g/dL
- •- WBC >/= 3,000/mm3
- •- Absolute neutrophil count >/= 1,500/mm3
- •- Platelet count >/= 100,000/mm3
- •- Bilirubin within normal limits
- •- Creatinine
- •Cardiovascular:
- •- No New York Heart Association (NYHA) class III or IV heart failure (see Attachment
- •- No unstable angina pectoris
- •- No arrhythmia needing continuous treatment
- •No other uncontrolled concurrent illness
- •11. Negative pregnancy test at enrollment (females of childbearing potential only)
- •12. Agreement to use highly effective contraception methods (intra-uterine
- •contraceptive device [IUCD], condoms, oral contraceptives, or other adequate
- •barrier contraception) in females of child-bearing potential
- •13. In case the patients participate in the optional PET-Scan substudy: Able to
- •tolerate PET imaging
- •14. 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 chemotherapy regimens (including those given in an
- •adjuvant or neo-adjuvant setting)
- •2. Peripheral neuropathy
- •3. Any prior treatment with epothilones
- •4. Use of any investigational drug within 4 weeks before start of study treatment
- •or inadequate recovery from any toxic effects of such therapy
- •5. Candidacy for curative resection
- •6. Brain metastases requiring whole-brain irradiation
- •7. Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in
- •situ of the cervix
- •8. Active infection
- •9. Breast-feeding
- •10. Any conditions that in the opinion of the investigator could hamper the
- •compliance with the study protocol
- •11. In case the patients participate in the optional PET-Scan substudy: Poorly
- •controlled diabetes defined as fasting glucose levels of >200 mg/dL.
研究者
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