A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Incidence of adverse events
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 either paclitaxel and carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with locally advanced or metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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, incurable, locally advanced, or metastatic solid malignancy
- •Adequate hematologic and end organ function
- •For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study
- •Measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors), with the exception of prostate cancer (two rising PSA Levels that meet the criteria of progression per PSA Working Group) and ovarian cancer (two rising CA-125 levels greater than the ULN)
排除标准
- •Current dyspnea at rest due to complications of advanced malignancy, or other conditions requiring continuous supplemental oxygen
- •Uncontrolled hypomagnesemia or hypokalemia
- •History of Grade >= 3 fasting hyperglycemia
- •Any condition requiring full-dose anticoagulants
- •Known HIV infection
- •Known untreated or active central nervous system (CNS) metastases
- •Pregnancy, lactation, or breastfeeding
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
- •For Arm B: Conditions that preclude the use of bevacizumab
- •For Arm C: Conditions that preclude the use of pemetrexed or cisplatin
研究组 & 干预措施
C
干预措施: cisplatin (Drug)
A
干预措施: GDC-0980 (Drug)
A
干预措施: carboplatin (Drug)
A
干预措施: paclitaxel (Drug)
B
干预措施: GDC-0980 (Drug)
B
干预措施: bevacizumab (Drug)
B
干预措施: carboplatin (Drug)
B
干预措施: paclitaxel (Drug)
C
干预措施: GDC-0980 (Drug)
C
干预措施: pemetrexed (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
Severity of adverse events
时间窗: Up to 30 days after last dose of study treatment
Incidence of dose limiting toxicities (DLTs)
时间窗: Up to 21 days from Last Patient In (LPI) in Stage 1 of study
Nature of adverse events
时间窗: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
Nature of dose limiting toxicities (DLTs)
时间窗: Up to 21 days from Last Patient In (LPI) in Stage 1 of study
次要结局
- Total exposure(Up to 32 months or early study discontinuation)
- Maximum plasma concentration(Up to 32 months or early study discontinuation)
- Time to maximum observed plasma concentration(Up to 32 months or early study discontinuation)
- Plasma half-life(Up to 32 months or early study discontinuation)