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

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY2090314
FOLFOX
Gemcitabine
Nab-paclitaxel
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic of Jacksonville
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

LY2090314 + Gemcitabine

LY2090314 + FOLFOX

LY2090314 + Gemcitabine + Nab-paclitaxel

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
Percentage of Participants Who Survived at 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.
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.

Full Information

First Posted
June 28, 2012
Last Updated
January 11, 2019
Sponsor
Eli Lilly and Company
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01632306
Brief Title
A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer
Official Title
Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients With Metastases Amenable to Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Study has been terminated due to slow enrollment.
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY2090314 + Gemcitabine
Arm Type
Experimental
Arm Description
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.
Arm Title
LY2090314 + FOLFOX
Arm Type
Experimental
Arm Description
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.
Arm Title
LY2090314 + Gemcitabine + Nab-paclitaxel
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
LY2090314
Intervention Description
LY2090314 administered IV
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Other Intervention Name(s)
FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin)
Intervention Description
FOLFOX administered IV
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar, LY188011
Intervention Description
Gemcitabine administered IV
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Nab-paclitaxel administered IV
Primary Outcome Measure Information:
Title
Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation
Description
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 Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Baseline to Date of Death Due to any Cause Up to 21 Months
Title
Percentage of Participants Who Survived at 6 Months
Time Frame
Baseline to Date of Death to any cause Up to 6 Months
Title
Progression Free Survival (PFS)
Description
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
Title
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic of Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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