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

This study has been terminated.
(Study has been terminated due to slow enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632306
First Posted: July 2, 2012
Last Update Posted: April 29, 2016
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.
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Eli Lilly and Company
  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 Drug: Nab-paclitaxel Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death to any cause up to 2 Years ]
  • 6 Months Survival [ Time Frame: Baseline to Date of Death to any cause up to 6 Months ]
  • Progression Free Survival [ Time Frame: Baseline to Disease Progression up to 2 Years ]
  • Confirmed Tumor Response [ Time Frame: Up to 8 Months from Baseline ]

Enrollment: 13
Study Start Date: March 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01632306     History of Changes
Obsolete Identifiers: NCT01671202
Other Study ID Numbers: 14453
I2H-MC-JWYD ( Other Identifier: Eli Lilly and Company )
First Submitted: June 28, 2012
First Posted: July 2, 2012
Last Update Posted: April 29, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Oxaliplatin
Albumin-Bound Paclitaxel
Fluorouracil
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