NL-OMON53513尚未招募2 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 - Effect of Ixabepilone in Recurrent or Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 5
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients with histologically or cytological confirmed adenocarcinoma of the
- •breast and with confirmed locally recurrent or metastatic disease
- •2. Patients with hormone receptor positive and HER2 negative or triple negative
- •primary tumor.
- •3. Previous chemotherapies (neoadjuvant, adjuvant or in the metastatic setting)
- •must have included a taxane and an anthracycline unless anthracycline therapy
- •is not indicated.
- •4. Maximum of three (3) prior chemotherapies in the metastatic setting in
- •addition to any number of prior lines of endocrine therapy
- •5. Measurable disease by RECIST v 1.1 criteria
- •6. Performance status of ECOG <= 1
- •7. DRP-Ixempra-Breast - score of >33% in an archival biopsy or in a more
- •recent biopsy. If two biopsies are available and disagree the archival biopsy
- •takes precedence.
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 the following strong inhibitors
- •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 the following strong inducers of
- •CYP3A4: 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
研究者
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