NCT04796324终止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 DRP After Failure of an Anthracycline and Taxanes.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 19
- 主要终点
- Clinical Benefit Rate (CBR)
研究概览
简要总结
The purpose is to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the Ixabepilone DRP after failure of an anthracycline and taxanes.
详细描述
Patients will be screened with the Ixabepilone DRP. If the tumor tissue has a DRP( Drug Response Prediction) score of >67% (Belgium >33%) the patient can be included in the clinical study. Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Age 18 years or older
- •Patients with histologically or cytological confirmed carcinoma of the breast. Patients with locally recurrent or metastatic disease
- •Patients with HR-positive, HER negative tumors or triple negative tumors
- •Previous chemotherapies (neo, adjuvant or in the metastatic setting) must have included a taxane and an anthracycline unless anthracycline therapy is not indicated.
- •Maximum of three (3) prior chemotherapies in the metastatic setting in addition to any number of prior lines of endocrine therapy
- •Measurable disease
- •Performance status of ECOG ≤ 1
- •With an Ixabepilone DRP - score of >33% (Germany >67%)
- •Adequate conditions as evidenced by the following clinical laboratory values:
- •Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
- •Hemoglobin > 6.2 mmol/L
- •Platelets ≥ 100 x 109 /L
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
- •Serum bilirubin ≤ 1.0 ULN
- •Alkaline phosphatase ≤ 2.5 x ULN or ≤5x ULN if documented liver/bone metastases. Creatinine ≤ 1.5 ULN
- •Blood urea within normal limits
- •Because of possible interference of cytochrome P450 3A4 activity by ixabepilone, patients were excluded from receiving the following medications at enrollment and while enrolled onto the study: amiodarone, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, indinavir, nelfinavir, ritonavir, and saquinavir
- •Women of childbearing age and potential must be willing to use effective contraception during the study and at least until 90 days 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 90 days 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 such as intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections)
排除标准
- •HER2 positive tumor
- •Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
- •Patients with intracranial disease
- •Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
- •Any active infection requiring parenteral or oral antibiotic treatment.
- •Patients with grade 2, in case of diabetes grade 1 or greater neuropathy
- •Clinically significant (i.e. active) cardiovascular disease:
- •Stroke within ≤ 6 months prior to day 1
- •Transient ischemic attach (TIA) within ≤ 6 months prior to day 1
- •Myocardial infarction within ≤ 6 months prior to day 1
- •Unstable angina
- •New York Hart Association (NYHA) Class II or greater congestive heart failure (CHF)
- •Serious cardiac arrhythmia requiring medication
- •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.
- •Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy
- •Female patients who are pregnant or breast-feeding (pregnancy test with a positive result before study entry)
- •Known prior severe hypersensitivity reactions to agents containing polyoxyethylated castor oil (Cremophor EL)
- •Known hypersensitivity to fluoropyrimidines;
- •Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency;
- •Patients must not continue treatment with the following strong inhibitors of CYP3A4:
- •ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and voriconazole. These therapies should be discontinued 72 hours prior to initiation of study drug therapy.
研究组 & 干预措施
Ixabepilone
Experimental
Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
干预措施: Ixabepilone Injection (Drug)
结局指标
主要结局
Clinical Benefit Rate (CBR)
时间窗: Baseline to 24 weeks
To evaluate the clinical benefit rate of ixabepilone using tumor measurements (e.g. CT or MRI etc.). One-sided comparisons of CBR between treatment and historic control will be performed, and will be repeated for subgroups defined by ER status.
次要结局
- Progression Free Survival (PFS)(1 year)
- Overall Survival (OS)(1 year)
- Overall Response Rate (ORR) Defined as CR + PR(1 year)
- Incidence of Treatment-Emergent Adverse Events Measured by NCI-CTCAE v.5.0(1 year)
- Clinical Benefit Rate (CBR) - Fresh Biopsy Versus Archival(1 year)
研究者
研究点 (19)
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