Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients With Metastases Amenable to Biopsy
Overview
- Phase
- Phase 1
- Intervention
- LY2090314
- Conditions
- Pancreatic Cancer
- Sponsor
- Eli Lilly and Company
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: LY2090314
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.
Intervention: Gemcitabine
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.
Intervention: LY2090314
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.
Intervention: FOLFOX
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.
Intervention: LY2090314
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.
Intervention: Gemcitabine
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.
Intervention: Nab-paclitaxel
Outcomes
Primary Outcomes
Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation
Time Frame: 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.
Secondary Outcomes
- 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)