A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer

Browse trials for

• Pancreatic Neoplasms 3,235

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 13 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• Experimental
  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.

  Drug: LY2090314 · Drug: Gemcitabine

• Experimental
  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.

  Drug: LY2090314 · Drug: FOLFOX

• Experimental
  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.

  Drug: LY2090314 · Drug: Gemcitabine · Drug: Nab-paclitaxel

Interventions

• DrugLY2090314

  LY2090314 administered IV

• DrugFOLFOX

  FOLFOX administered IV

  Also known as: FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin)

• DrugGemcitabine

  Gemcitabine administered IV

  Also known as: Gemzar, LY188011

• DrugNab-paclitaxel

  Nab-paclitaxel administered IV

Primary outcomes

1. Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation

   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.

   Time frame: Baseline, 4 Hours Post-Treatment on Day 0

Secondary outcomes

1. Overall Survival (OS)

   Time frame: Baseline to Date of Death Due to any Cause Up to 21 Months

2. Percentage of Participants Who Survived at 6 Months

   Time frame: Baseline to Date of Death to any cause Up to 6 Months

3. Progression Free Survival (PFS)

   PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first.

   Time frame: Baseline to Disease Progression Up to 18 Months

4. Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

   Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size \[\<10 millimeter (mm) short axis\]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100. A CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.

   Time frame: Baseline Up to 6 Months

Baseline characteristics