EUCTR2020-004610-35-NL招募中1 期
Phase II, open label, single arm study to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the ixabepilone Drug Response Prediction (DRP) after failure of an anthracycline and a taxane
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Signed informed consent form
- •2.Age 18 years or older
- •3.Patients with histologically or cytological confirmed adenocarcinoma of the breast and with confirmed locally recurrent or metastatic disease
- •4.Patients with hormone receptor positive and HER2 negative or triple negative primary tumor.
- •5.Previous chemotherapies (neoadjuvant, adjuvant or in the metastatic setting) must have included a taxane and an anthracycline unless anthracycline therapy is not indicated or not in use.
- •6.Maximum of three (3) prior chemotherapies in the metastatic setting in addition to any number of prior lines of endocrine therapy
- •7.Measurable disease by RECIST v 1.1 criteria
- •8.Performance status of ECOG = 1
- •9. Ixabepilone DRP - score of >33%
- •10.Adequate conditions as evidenced by the following clinical laboratory values:
- •a.Absolute neutrophils count (ANC) = 1.5 x 109/L
- •b.Hemoglobin > 10 g/dL (6.2 mmol/L)
- •c.Platelets = 100 x 109 /L
- •d.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN
- •e.Serum bilirubin = 1.0 ULN
- •f.Creatinine = 1.5 ULN
- •g.Alkaline phosphatase = 2.5 x ULN or =5x ULN if documented liver/bone metastases.
- •h.Blood urea within normal limits
- •11.Negative pregnancy test at baseline
- •12.Women of childbearing age and potential must be willing to use effective contraception during the study and at least until 7 months after last dose of study drug. Male patients or male patients who have female partners of childbearing age and potential must be willing to use effective contraception during the study and at least until 4 months after last dose of study drug. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.HER2 positive tumor
- •2.Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
- •3.Patients with intracranial disease
- •4.Other malignancies with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
- •5.Any active infection requiring parenteral or oral antibiotic treatment.
- •6.Patients with grade 2, in case of diabetes grade 1 or greater neuropathy
- •7.Clinically significant (i.e. active) cardiovascular disease:
- •a.Stroke within = 6 months prior to day 1
- •b.Transient ischemic attach (TIA) within = 6 months prior to day 1
- •c.Myocardial infarction within = 6 months prior to day 1
- •d.Unstable angina
- •e.New York Hart Association (NYHA) Class II or greater congestive heart failure (CHF)
- •f.Serious cardiac arrhythmia requiring medication
- •8.Other medications or conditions, including surgery, that in the Investigator’s opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results
- •9.Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy
- •10.Female patients who are pregnant or breast-feeding (pregnancy test with a positive result before study entry)
- •11.Known prior severe hypersensitivity reactions to agents containing polyoxyethylated castor oil (Cremophor EL)
- •12.Patients must not continue treatment with strong inhibitors of CYP3A4 e.g.:
- •Clarithromycin, ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, saquinavir and voriconazole. These therapies should be discontinued 72 hours prior to initiation of study drug therapy. Similarly, patients must not continue treatment with strong inducers of CYP3A4 e.g.: phenytoin, carbamazepine, rifampin, rifabutin, dexamethasone, and phenobarbital. (20 mg dexamethasone can be used for pre-treatment if required). These therapies should be discontinued 72 hours prior to initiation of study drug therapy
- •13.Positive HIV and hepatitis B and C status, assessed from medical records only
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