NCT01113970Unknown1 期
Phase I/II Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Phase I- Maximum Tolerated Dose
研究概览
简要总结
This study is a Phase I/II trial of a novel Indibulin dosing schedule for the treatment of metastatic breast cancer. Eligible patients will have measurable or non-measurable, metastatic or unresectable, locally advanced breast cancer and may have received any number of prior therapies for their disease.
It is expected that the Phase I portion will enroll up to 20 patients and the Phase II portion will enroll up to 45 patients.
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
- •Histologic or cytologic confirmation of invasive carcinoma of the breast.
- •Clinical evidence of metastatic disease or locally advanced disease not amenable to curative therapy.
- •Measurable or non-measurable lesions according to the RECIST Version 1.1
- •Any number of prior endocrine, biologic or chemotherapy regimens is permitted. All previous chemotherapy and biologic therapy must have been discontinued at least 3 weeks prior to beginning study drug. Endocrine therapy may not be used concurrently with protocol treatment. All acute toxic effects (excluding alopecia or neuropathy) of any prior therapy must have resolved to NCI CTC (version 4.0) Grade ≤ 1 or to baseline
- •Prior radiation therapy is permitted.
- •ECOG performance status of 0, 1 or
- •Age ≥ 18 years
- •Life expectancy ≥ 12 weeks
- •Patients with HER2-positive (IHC 3+ or FISH-amplified) breast cancer must have received trastuzumab or have a contradiction to receiving HER2- targeted therapy (such as abnormal left ventricular ejection fraction)as determined by the treating physician.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
- •Creatinine ≤ 1.5x upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5x ULN
- •ALT or AST ≤ 2.5x ULN
- •ANC ≥ 1.5 x10(9)/L
- •Platelets ≥ 100 x10(9)/L
- •Hemoglobin ≥ 9g/dL
- •Subjects of childbearing potential must agree to use a barrier method of contraception throughout the study and for 3 months after study drug administration.
排除标准
- •Pregnant or nursing women may not participate.
- •Serious, uncontrolled, concurrent infection.
- •Patients with symptomatic CNS metastases that remain untreated by radiation therapy are excluded from this trial. The presence of asymptomatic, previously irradiated, stable brain metastases for at least 3 months are not grounds for trial exclusion.
- •Presence of uncontrolled gastrointestinal malabsorption syndrome.
- •Any chemotherapy, radiotherapy or breast cancer directed biologic therapy during the study or within 3 weeks of study start. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry. No washout period is required for hormonal therapies.
- •Concurrent radiation therapy is not permitted during treatment on protocol.
- •History of an invasive second primary malignancy diagnosed within the previous 3 years, except for Stage I endometrial or cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.
- •Any medical, psychological or social condition that may interfere with the subject's ability to safely participate in the study.
- •Unwillingness to give written informed consent or unwillingness to participate or inability to comply with the protocol for the duration of the study. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures are necessary for participation in this clinical trial.
研究组 & 干预措施
Single Arm
Experimental
open label, single arm, unblinded
干预措施: Indibulin (Drug)
结局指标
主要结局
Phase I- Maximum Tolerated Dose
时间窗: Throughout Cycle 1 (28 days)
The primary objective of the Phase I portion of the trial is to determine the maximum tolerated dose (MTD) of Indibulin when given for 5 days followed by a 9 day rest (5-9) using a standard 3+3 dose escalation scheme for the treatment of metastatic breast cancer
Phase II- Progression Free Survival
时间窗: 4 months
The primary objective of the Phase II portion of this trial is to examine the efficacy of indibulin for the treatment of metastatic breast cancer at the MTD established in Phase I. The primary endpoint is the proportion of patients who are progression free at 4 months when treated with Indibulin (5-9)at the MTD determined by the phase I portion of the trial.
次要结局
- Phase I- Number of participants with Adverse Events as a measure of safety and tolerability(Duration of study, approximately one year)
- Phase I- Toxicity(Cycle 1 (28 days), and duration of study (approximately one year))
- Phase I- Pharmacokinetics of indibulin in study subject plasma assessed in Cycle 1 Day 1 and Cycle 1 Day 5 per schedule below in Description section.(During Cycle 1 (28 days))
- Phase II- Overall Response Rate(At the end of Cycles 4 and 6 (approximately 4 months and 6 months respectively))
- Phase II- Rate of Stable Disease(Phase II- greater than 6 months)
- Phase II- Number of patients with Adverse Events as a measure of safety and tolerability(Throughout study, approximately one year)
研究者
研究点 (4)
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