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

Phase 1

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: LY2090314; Drug: FOLFOX; Drug: Gemcitabine; Drug: Nab-paclitaxel

• Registration Number: NCT01632306
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-02
• Study Start: 2013-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Disposition First Submitted: 2016-03-28
• Disposition First Submitted QC: 2016-03-28
• Disposition First Posted: 2016-04-29
• Results First Submitted: 2018-10-17
• Results First Submitted QC: 2018-10-17
• Results First Posted: 2018-11-19
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY2090314 + Gemcitabine + Nab-paclitaxel	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.
LY2090314 + FOLFOX	LY2090314	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.
LY2090314 + FOLFOX	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.
LY2090314 + Gemcitabine + Nab-paclitaxel	LY2090314	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.
LY2090314 + Gemcitabine	LY2090314	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.
LY2090314 + Gemcitabine	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.
LY2090314 + Gemcitabine + Nab-paclitaxel	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation	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 Outcome Measures

Name	Time	Method
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	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.
Progression Free Survival (PFS)	Baseline to Disease Progression Up to 18 Months	PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first.

Trial Locations

Locations (2)

Mayo Clinic of Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States