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

This study is currently recruiting participants.
Verified April 2013 by Eli Lilly and Company
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01632306
First received: June 28, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Cancer
 Drug: LY2090314
Drug: FOLFOX
Drug: Gemcitabine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death to any cause up to 2 Years ] [ Designated as safety issue: No ]
  • 6 Months Survival [ Time Frame: Baseline to Date of Death to any cause up to 6 Months ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: Baseline to Disease Progression up to 2 Years ] [ Designated as safety issue: No ]
  • Confirmed Tumor Response [ Time Frame: Up to 8 Months from Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2090314 + Gemcitabine
10-40 mg 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.
 Drug: LY2090314
LY2090314 administered IV
Drug: Gemcitabine
Gemcitabine administered IV
Other Names:
  • Gemzar
  • LY188011
Experimental: LY2090314 + FOLFOX
10-40 mg 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632306

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559 1-317-615-4559

Locations
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Jacksonville, Florida, United States, 32224
Contact: Eli Lilly            
United States, Minnesota
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Rochester, Minnesota, United States, 55905
Contact: Eli Lilly            
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01632306     History of Changes
Obsolete Identifiers: NCT01671202
Other Study ID Numbers: 14453, I2H-MC-JWYD
Study First Received: June 28, 2012
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Gemcitabine
Oxaliplatin
Leucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on June 17, 2013