Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients With Metastases Amenable to Biopsy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation
研究概览
简要总结
Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Metastatic pancreatic cancer with metastases amenable to biopsy
- •Willingness to provide tissue and blood samples for research purposes
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
排除标准
- •History of islet cell, acinar cell, or cystadenocarcinomas
- •Prior cytotoxic chemotherapy for metastatic disease, except prior gemcitabine or FOLFIRINOX (5FU + leucovorin + irinotecan + oxaliplatin)
- •Radiation therapy, immunotherapy or biologic therapy <28 days prior to study entry
研究组 & 干预措施
LY2090314 + Gemcitabine
LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m^2) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum.
干预措施: LY2090314 (Drug)
LY2090314 + Gemcitabine
LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m^2) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum.
干预措施: Gemcitabine (Drug)
LY2090314 + FOLFOX
LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle.
干预措施: LY2090314 (Drug)
LY2090314 + FOLFOX
LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle.
干预措施: FOLFOX (Drug)
LY2090314 + Gemcitabine + Nab-paclitaxel
LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 mg/m^2 gemcitabine + 125 mg/m^2 nab-paclitaxel given IV on days 1, 8 and 15 in 28-day cycle. New cohort opened per protocol amendment.
干预措施: LY2090314 (Drug)
LY2090314 + Gemcitabine + Nab-paclitaxel
LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 mg/m^2 gemcitabine + 125 mg/m^2 nab-paclitaxel given IV on days 1, 8 and 15 in 28-day cycle. New cohort opened per protocol amendment.
干预措施: Gemcitabine (Drug)
LY2090314 + Gemcitabine + Nab-paclitaxel
LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 mg/m^2 gemcitabine + 125 mg/m^2 nab-paclitaxel given IV on days 1, 8 and 15 in 28-day cycle. New cohort opened per protocol amendment.
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation
时间窗: Baseline, 4 Hours Post-Treatment on Day 0
Change in the phosphorylation level of glycogen synthase, a glycogen synthase kinase-3 beta (GSK-3beta) inhibitor, from baseline to 4 hours post-treatment on day 0 using tumor tissue and blood specimens.
次要结局
- Percentage of Participants Who Survived at 6 Months(Baseline to Date of Death to any cause Up to 6 Months)
- Overall Survival (OS)(Baseline to Date of Death Due to any Cause Up to 21 Months)
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)](Baseline Up to 6 Months)
- Progression Free Survival (PFS)(Baseline to Disease Progression Up to 18 Months)