NCT00736970已完成2 期
A Phase II Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Trastuzumab for Patients With HER2-positive Trastuzumab-Refractory Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Objective Response Rate (ORR) measured by modified RECIST guidelines
研究概览
简要总结
This clinical trial will study the use of ridaforolimus in metastatic breast cancer subjects whose tumors have shown a resistance to trastuzumab (herceptin). The goal of this study is to find out if subjects treated with ridaforolimus in combination with trastuzumab have a positive response to the treatment, and if treatment with ridaforolimus in combination with trastuzumab prolongs survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18 years of age or older
- •Histologically confirmed HER2-positive metastatic breast cancer
- •Trastuzumab-resistance
- •Measurable disease, according to RECIST guidelines
- •ECOG performance status less than or equal to 1
- •Life expectancy greater than 3 months
- •No prior treatment with temsirolimus, everolimus, rapamycin, or any other mTOR inhibitor
- •At least 4 weeks must have lapsed between prior investigational therapy, chemotherapy or radiotherapy, and the first dose of ridaforolimus
- •Left ventricular ejection greater than or equal to 50%
- •Adequate cardiovascular function
- •Adequate hematological, hepatic, and renal function
- •Serum cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL
- •Negative pregnancy test within 7 days prior to first dose of study drug and must use an approved contraceptive method from screening to 30 days after the last dose of study drug
- •Availability and patient consent to obtain archival tissue samples
- •Signed informed consent
排除标准
- •Inadequate recovery from any prior surgical procedure or having undergone any major surgery within 2 weeks before trial entry
- •Grade 1 or Grade 2 hypersensitivity reactions to prior trastuzumab therapy if these reactions prevented further trastuzumab administration
- •Grade 3 or Grade 4 hypersensitivity reaction to prior trastuzumab
- •Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
- •Known allergy to macrolide antibiotics
- •Pregnant or breast-feeding
- •Know history of HIV
- •Diagnosis of brain metastasis or leptomeningeal carcinomatosis within 3 months
- •Other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
- •Active infection requiring prescription intervention
- •Newly diagnosed or poorly controlled Type 1 or 2 diabetes
- •Other concurrent illness which, in the Investigator's judgment, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
- •Concurrent treatment with medications that strongly induce or inhibit cytochrome P
- •Any condition that renders patient unable to fully understand and provide informed consent and/or comply with the protocol
研究组 & 干预措施
1
Experimental
10 mg oral tablets administered at 40 mg once daily for 5 consecutive days each week, followed by 2 days without ridaforolimus
干预措施: ridaforolimus (Drug)
1
Experimental
10 mg oral tablets administered at 40 mg once daily for 5 consecutive days each week, followed by 2 days without ridaforolimus
干预措施: trastuzumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR) measured by modified RECIST guidelines
时间窗: Duration of the study
次要结局
- Characterize the overall safety and tolerability of oral deforolimus administered in combination with standard dose trastuzumab(Duration of the study)
- Evaluate the clinical-benefit response rate (CR or PR, or SD ≥ six 4-week cycles)(Throughout the trial)
- Evaluate additional efficacy endpoints, such as duration of response, time to tumor progression, progression-free survival, progression free survival rate, and overall survival(Duration of the trial)
- Perform exploratory molecular analyses(Duration of the trial)
研究者
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