EUCTR2009-011878-15-FR进行中（未招募）1 期
A phase 1/2, open-label study of bosutinib administered in combination with capecitabine in subjects with solid tumor and ErbB2 negative locally advanced or metastatic breast cancer.
Wyeth Research Division of Wyeth Pharmaceuticals Inc0 个研究点目标入组 152 人开始时间: 2009年8月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Part 1 only: Subjects with confirmed pathologic diagnosis of advanced breast cancer or pancreatic cancer or colorectal cancer or cholangiocarcinoma or glioblastoma that is not curable with available therapies, for whom bosutinib plus capecitabine is a reasonable treatment option.
- •Part 2 only: Subjects with confirmed pathologic diagnosis of locally advanced or metastatic breast cancer, or loco-regional recurrent breast cancer that is not amenable to curative treatment with surgery or radiotherapy.
- •Part 2 only: Documented ER+ and/or PgR+/erbB2- (Arm A only) or ER-/PgR-/erbB2- (Arm B only) tumor based on most recently analyzed biopsy, as documented by a local laboratory.
- •Part 2 only: Subjects must have received at least one but no more than 2 prior cytotoxic chemotherapy regimens for metastatic breast cancer.
- •Parts 1 & 2: At least 1 radiologically measurable lesion as defined by RECIST v1.0.
- •Part 2 only: Availability of formalin-fixed paraffin embedded (FFPE) tumor tissue block preferably or alternatively unstained slides for exploratory biomarker analysis.
- •Parts 1 & 2: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Parts 1 & 2: Prior bosutinib, or any other prior Src inhibitor.
- •Part 1 only: Prior chemotherapy with capecitabine or 5-fluorouracil (5-FU) for the treatment of metastatic disease is allowed unless patient stopped therapy for toxicity (including but not limited to hand and foot syndrome, grade 3/4 diarrhea, etc).
- •Part 2 only: Prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease.
- •Part 2 only: Prior chemotherapy with capecitabine or 5-FU for adjuvant chemotherapy within the past 12 months
- •Part 2 only: erbB2+ breast cancer
- •Parts 1 & 2: Cytotoxic chemotherapy, investigational therapy, major surgery or radiation therapy within 14 days of treatment day 1.
- •Parts 1 & 2: Bone or skin as the only site of disease.
- •Parts 1 & 2: Clinically unstable primary or metastatic central nervous system (CNS) tumors. Subjects with progression of CNS tumors are eligible as long as they have been clinically stable for at least 4 weeks prior to first dose of bosutinib and capecitabine (ie, no significant change in anticonvulsant or corticosteroid doses, mental status, or clinical symptoms).
- •Part 2 only: Any other cancer within 5 years before screening with the exception of adequately treated cervical cancer in situ, or adequately treated basal or squamous cell cancer of the skin.
- •Parts 1 & 2: Inadequate hepatic/renal/bone marrow function.
- •Parts 1 & 2: History of clinically significant or uncontrolled cardiac disease.
- •Parts 1 & 2: Serious concurrent illness.
研究者
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