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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01632306
Recruitment Status : Terminated (Study has been terminated due to slow enrollment.)
First Posted : July 2, 2012
Results First Posted : November 19, 2018
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: LY2090314 Drug: FOLFOX Drug: Gemcitabine Drug: Nab-paclitaxel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients With Metastases Amenable to Biopsy
Study Start Date : March 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 enrollment per protocol addendum.
 Drug: LY2090314
LY2090314 administered IV

Drug: Gemcitabine
Gemcitabine administered IV
Other Names:
  • Gemzar
  • LY188011
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
Other Name: FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin)
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
LY2090314 administered IV

Drug: Gemcitabine
Gemcitabine administered IV
Other Names:
  • Gemzar
  • LY188011

Drug: Nab-paclitaxel
Nab-paclitaxel administered IV


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  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) [ Time Frame: 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.

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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632306


Locations
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United States, Florida
Mayo Clinic of Jacksonville
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Eli Lilly and Company
Mayo Clinic
Investigators
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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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01632306    
Obsolete Identifiers: NCT01671202
Other Study ID Numbers: 14453
I2H-MC-JWYD ( Other Identifier: Eli Lilly and Company )
First Posted: July 2, 2012    Key Record Dates
Results First Posted: November 19, 2018
Last Update Posted: January 15, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Gemcitabine
Paclitaxel
Fluorouracil
Oxaliplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex