A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Overall Confirmed Objective Disease Response
研究概览
简要总结
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.
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
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
- •HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
- •Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.
排除标准
- •Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
- •Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
- •Prior treatment on a SU11248 clinical trial.
- •Uncontrolled brain metastases.
研究组 & 干预措施
A
干预措施: SU011248/Trastuzumab (Drug)
结局指标
主要结局
Percentage of Participants With Overall Confirmed Objective Disease Response
时间窗: From start of treatment through 18 months
Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a \> = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.
次要结局
- Duration of Response (DR)(From start of treatment through 18 months)
- Percentage of Participants With Clinical Benefit(From start of treatment through 18 months)
- Progression Free Survival (PFS)(From start of treatment through 18 months)
- Time to Progression (TTP)(From start of treatment through 18 months)
- Overall Survival (OS)(From start of study treatment until death or 2 years from first study treatment)
- Probability of Survival at One Year(From start of study treatment until death or 2 years from first study treatment)
- EORTC QLQ-C30(From start of treatment through 18 months)
- EORTC QLQ (BR23)(From start of treatment through 18 months)
- Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib(Predose on Day 1 of Cycle 3 and 5)
- Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)(Predose on Day 1 of Cycle 3 and 5)
- Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)(Predose on Day 1 of Cycle 3 and 5)