NCT01332604已完成1 期
A Phase Ib, Open Label, Dose Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Nature of adverse events graded according to NCI CTCAE, v4.0
研究概览
简要总结
This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors.
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
- •Histologically or cytologically documented locally advanced or metastatic solid tumors for which established therapy is ineffective, not tolerable, or does not exist
- •Patients with histologically or cytologically documented locally advanced or metastatic breast cancer who have received at least one prior chemotherapy-based regimen for incurable disease (Arm A)
- •Patients with histologically or cytologically documented locally advanced or metastatic CRC who have not received prior oxaliplatin-based therapy within 1 year of initiation of study treatment. (Arm B)
排除标准
- •Prior anti-cancer therapy that fulfills the following criteria: a total of more than six courses of an alkylating agent, a total of more than four courses of carboplatin-containing chemotherapy regimens, and a total of more than two courses of nitrosoureas or mitomycin C, high-dose chemotherapy requiring stem-cell support, and irradiation to >= 25% of bone marrow-bearing areas
- •Current dyspnea at rest because of complications of advanced malignancy or other disease requiring continuous oxygen therapy
- •Known deficiency of dihydropyrimidine dehydrogenase (DPD)
- •Bisphosphonate therapy for symptomatic hypercalcemia
- •Known untreated or active central nervous system (CNS) metastases
- •Pregnancy, lactation, or breastfeeding
- •Inadequately controlled hypertension
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •History of myocardial infarction or unstable angina within 6 months prior to the first dose of study treatment
- •History of stroke or transient ischemic attacks within 6 months prior to the first dose of study treatment
- •Significant vascular disease within 6 months prior to the first dose of study treatment
- •History of hemoptysis within 1 month prior to the first dose of study treatment
- •Patients with one or more pulmonary tumor masses with evidence of cavitation
- •Evidence of bleeding diathesis or significant coagulopathy
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of study treatment
- •History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to the first dose of study treatment
- •Clinical signs or symptoms of GI obstruction or requirement for parenteral hydration, parenteral nutrition, or tube feeding
- •Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- •Serious, non-healing wound, active ulcer, or untreated bone fracture
- •The presence of an ulcerating breast cancer tumor will not render a patient ineligible
- •Proteinuria
研究组 & 干预措施
A
Experimental
干预措施: GDC-0980 (Drug)
A
Experimental
干预措施: capecitabine (Drug)
B
Experimental
干预措施: GDC-0980 (Drug)
B
Experimental
干预措施: bevacizumab (Drug)
B
Experimental
干预措施: mFOLFOX6 (Drug)
结局指标
主要结局
Nature of adverse events graded according to NCI CTCAE, v4.0
时间窗: Up to 30 days after last dose of study treatment
Severity of adverse events
时间窗: Up to 30 days after last dose of study treatment
Incidence of adverse events
时间窗: Up to 30 days after last dose of study treatment
Nature of dose limiting toxicities (DLTs)graded according to NCI CTCAE, v4.0
时间窗: Up to 28 days
Incidence of dose limiting toxicities (DLTs)
时间窗: Up to Day 21 for Arm A and up to Day 28 for Arm B
次要结局
- Total exposure from Time 0 to the last measurable concentration(Up to Day 2 for Arm B and up to Day 9 for Arm A)
- Maximum observed plasma concentration(Up to Day 2 for Arm B and up to Day 9 for Arm A)
- Minimum observed plasma concentration(Up to Day 2 for Arm B and up to Day 9 for Arm A)
- Time to maximum observed plasma concentration(Up to Day 2 for Arm B and up to Day 9 for Arm A)
研究者
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