A Study Of LY2090314 And Chemotherapy In Participants With Metastatic Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: LY2090314
DRUG: FOLFOX
DRUG: Gemcitabine
DRUG: Nab-paclitaxel

14453
I2H-MC-JWYD (OTHER Identifier) (OTHER: Eli Lilly and Company)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-06-28	Results First Submitted 2018-10-17	Last Update Submitted that met QC Criteria 2019-01-11
First Submitted that Met QC Criteria 2012-06-28	Results First Submitted that Met QC Criteria 2018-10-17	Last Update Posted (ACTUAL) 2019-01-15
First Posted (ACTUAL) 2012-07-02	Results First Posted 2018-11-19	Last Verified 2019-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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 enrollmen	DRUG: LY2090314 LY2090314 administered IV DRUG: Gemcitabine Gemcitabine administered IV DRUG: Nab-paclitaxel Nab-paclitaxel administered IV
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 LY2090314 administered IV DRUG: FOLFOX FOLFOX administered IV
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 proto	DRUG: LY2090314 LY2090314 administered IV DRUG: Gemcitabine Gemcitabine administered IV DRUG: Nab-paclitaxel Nab-paclitaxel administered IV

Participant Group/Arm

Intervention/Treatment

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 enrollmen

DRUG: LY2090314

LY2090314 administered IV

DRUG: Gemcitabine

Gemcitabine administered IV

DRUG: Nab-paclitaxel

Nab-paclitaxel administered IV

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

LY2090314 administered IV

DRUG: FOLFOX

FOLFOX administered IV

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 proto

DRUG: LY2090314

LY2090314 administered IV

DRUG: Gemcitabine

Gemcitabine administered IV

DRUG: Nab-paclitaxel

Nab-paclitaxel administered IV

Primary Outcome Measures	Measure Description	Time Frame
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.	Baseline, 4 Hours Post-Treatment on Day 0

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival (OS)		Baseline to Date of Death Due to any Cause Up to 21 Months
Percentage of Participants Who Survived at 6 Months		Baseline to Date of Death to any cause Up to 6 Months
Progression Free Survival (PFS)	PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first.	Baseline to Disease Progression Up to 18 Months
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.	Baseline Up to 6 Months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Mayo Clinic

Investigators

STUDY_DIRECTOR: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record