A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Adverse events as a measure of safety and tolerability of TGR-1202 as a single agent and in combination in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
研究概览
简要总结
This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with select relapsed or refractory solid tumors.
详细描述
TGR-1202 will be evaluated alone or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with adenocarcinoma of the pancreas, adenocarcinoma of the colon, rectum, gastric and GE junction cancer, and GI Stromal Tumor (GIST) who have relapsed from or are refractory to prior treatment.
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
- •Histologically confirmed:
- •adenocarcinoma of the pancreas (pancreatic cancer)
- •adenocarcinoma of the colon or rectum (colorectal cancer)
- •adenocarcinoma of the gastric (gastric cancer)
- •esophageal cancer
- •gastrointestinal stromal tumor (GIST)
- •Relapsed or refractory disease
- •Measurable lesion by RECIST 1.1
排除标准
- •Known Hepatitis B, C or HIV infection
- •Previous therapy with any drug that inhibits the PI3K pathway
- •Anti-tumor therapy within 21 days of study Day 1
研究组 & 干预措施
TGR-1202
TGR-1202 daily dose
干预措施: TGR-1202 (Drug)
TGR-1202 + nab-paclitaxel + gemcitabine
TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion
干预措施: TGR-1202 (Drug)
TGR-1202 + nab-paclitaxel + gemcitabine
TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion
干预措施: nab-paclitaxel + gemcitabine (Drug)
TGR-1202 + FOLFOX
TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen)
干预措施: TGR-1202 (Drug)
TGR-1202 + FOLFOX
TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen)
干预措施: Oxaliplatin + Folinic acid + Fluorouracil (Drug)
TGR-1202 + FOLFOX + Bevacizumab
TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) + bevacizumab IV infusion
干预措施: TGR-1202 (Drug)
TGR-1202 + FOLFOX + Bevacizumab
TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) + bevacizumab IV infusion
干预措施: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab (Drug)
结局指标
主要结局
Adverse events as a measure of safety and tolerability of TGR-1202 as a single agent and in combination in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
时间窗: Up to 28 days after the last patient enrolled
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
次要结局
- Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC)(At selected timepoints up through 6 months)
- Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax).(At selected timepoints up through 6 months)
- Duration of Response(Up to 1 year)
- Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax).(At selected timepoints up through 6 months)
- Overall Response Rate(Up to 1 year)