EUCTR2007-002083-98-HU进行中（未招募）不适用
A Phase II Study of Milataxel (TL139) Administered Orally or Intravenously in Taxane Naïve Patients with Metastatic Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
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
- All
入选标准
- •1.Patients with histologically or cytologically confirmed metastatic breast cancer. Patients must have had no prior taxane therapy.
- •2.Patients with Her 2+ (ICH 3+ or FISH +) breast cancer should preferably have been previously treated with trastuzumab.
- •There is no limit to the number or type of prior hormonal therapies.
- •3.Patients must have measurable disease by RECIST method criteria.
- •4.Patients must have an ECOG performance status of 0, 1 or 2 (Protocol Appendix, Attachment 1).
- •5.Patients must be at least 18 years of age. There is no upper age limit for inclusion in the study.
- •6.Patients must have adequate organ and system function. Renal: A serum creatinine of less than or equal to 1.5 times the institution’s upper normal limit, or a calculated creatinine clearance = 60 mL/min/1.73 m2. Hepatic: Total bilirubin less than or equal to 1.5 the institution’s upper normal limit. ALT or AST less than or equal to 2.5 times the institution’s upper normal limit. Bone marrow: An ANC of greater than or equal to 1,500/mm3, a platelet count of greater than or equal to 100,000/mm3, and hemoglobin greater or equal to 9 grams/dL.
- •7.Women of childbearing potential and sexually active males who agree to use an effective method of contraception prior to study entry, for the duration of the study and for 30 days after the last dose of milataxel.
- •8.A negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential.
- •9.Patients must be able to comply with the protocol treatments and procedures.
- •10.Patients must sign an informed consent form.
- •11.Patients who have recovered to grade 1 or better from all acute toxicities caused by prior cancer therapies. Residual toxicities, such as alopecia, which do not pose an ongoing medical risk, are acceptable.
- •12.Patients with known brain metastases, that are clinically stable; oral steroids for brain metastases are allowed, provided the dose has been stable for = 2 weeks. The maximum dexamethasone dose allowed is 4 mg every day.
- •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.Women who are pregnant or breastfeeding.
- •2.Prior cancer therapies not completed at least three weeks prior to the first cycle of milataxel; nitrosoureas or mitomycin C, completed less than six weeks prior to the first cycle; radiotherapy completed less than two weeks prior to study enrollment; patients not recovered from radiation-related toxicities; patients receiving any concurrent anticancer therapy, including trastuzumab, bevacizumab, or an investigational agent while on-study. Concurrent use of bisphosphonates is permitted. Patients who are on stable regimens of hormonal therapy e.g. tamoxifen, Aromatase Inhibitors, Megace may continue with this treatment.
- •3.Patients with grade 2 or greater peripheral neuropathy, of any etiology.
- •4.Patients with known sensitivity to alcohol (Oral and IV milataxel) and Cremophor (oral milataxel only).
- •5.Patients with significant intercurrent illnesses that could adversely affect the tolerance of milataxel, or the understanding of its effects. Examples include active cardiac disease not controlled by therapy, myocardial infarction within the previous six months, unstable diabetes, pancreatitis, pneumonia or any psychiatric disorder that prevents obtaining valid informed consent.
- •6.Oral Milataxel only: Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or major resection of the stomach or small bowel that could affect absorption of study drug.
- •7.Patients with symptomatic CNS metastases. However, patients with known brain metastases may be included in the study, providing they are clinically stable. Patients receiving high dose steroids (> 4mgs or equivalent) for brain metastases are not eligible.
- •8.Patients who have had major surgery within the past 14 days.
- •9.Oral Milataxel only: Patients who require or are likely to require any strong modifier of CYP450 activity to be taken prior to milataxel administration, including grapefruit juice and cranberry juice, during the study (see protocol Appendix, Attachment 2 for a list of agents). Note: omeprazole and low dose dexamethasone = 4 mg (or equivalent), every day are allowed.
研究者
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