NCT01254526已完成1 期
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Incidence and nature of dose-limiting toxicities (DLTs)
研究概览
简要总结
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with taxane-based chemotherapy regimens utilized in patients with locally recurrent or metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Locally recurrent or metastatic breast cancer, not amenable to resection with curative intent
- •For Arm C: Overexpression of HER2
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Adequate hematologic and organ function
- •Evaluable or measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors)
- •Female patients of childbearing potential must use an acceptable method of contraception to prevent pregnancy and to continue its use for the duration of the study
排除标准
- •Prior anti-cancer therapy of more than two regimens of systemic cytotoxic chemotherapy for advanced or metastatic breast cancer
- •Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
- •History of Type 1 or Type 2 diabetes requiring regular medication
- •History of clinically significant cardiac or pulmonary dysfunction
- •History of malabsorption syndrome or other condition that would interfere with enteral absorption
- •Any condition requiring full-dose anticoagulants
- •Leptomeningeal disease as a manifestation of cancer
- •Active infection requiring IV antibiotics
- •Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs, inhaled steroids, or the equivalent of <= 10 mg/day of prednisone
- •Known clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
- •Known HIV infection
- •Known untreated or active CNS metastases
- •Pregnancy, lactation, or breastfeeding
- •Major surgical procedure, open biopsy, or significant traumatic injury within a within a specified timeframe of the first dose of study treatment
- •Uncontrolled hypertension, complication from hypertension, myocardial infarctions, unstable angina, vascular disease or stroke within a specified timeframe of the first dose of study treatment
- •Evidence of bleeding diathesis or significant coagulopathy including hemoptysis within a specified timeframe of the first dose of study treatment
- •History of abdominal conditions (e.g., fistula, perforation, obstruction) that would preclude use of bevacizumab
- •Serious, non-healing wound, active ulcer, or untreated bone fracture
- •Proteinuria
研究组 & 干预措施
B
Experimental
干预措施: bevacizumab (Drug)
A
Experimental
干预措施: GDC-0980 (Drug)
A
Experimental
干预措施: paclitaxel (Drug)
B
Experimental
干预措施: GDC-0980 (Drug)
B
Experimental
干预措施: paclitaxel (Drug)
结局指标
主要结局
Incidence and nature of dose-limiting toxicities (DLTs)
时间窗: Through Day 22
Incidence, nature, and severity of adverse events
时间窗: Through study completion, up to 1 year, or early discontinuation
次要结局
- Pharmacokinetic parameters of GDC-0980, paclitaxel and bevacizumab (including total exposure, maximum and minimum plasma concentration, time to maximum observed plasma concentration, plasma half-life)(Through Day 22)
- Duration of response(Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation)
- Progression-free survival (PFS)(Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation)
- Objective tumor response(Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation)
研究者
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