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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 11, 2014
Last verified: July 2014

June 28, 2012
July 11, 2014
March 2013
May 2017   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01632306 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer
Phase I/II Study of LY2090314 and Chemotherapy in Metastatic Pancreatic Cancer Patients With Metastases Amenable to Biopsy

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: LY2090314
    LY2090314 administered IV
  • Drug: FOLFOX
    FOLFOX administered IV
    Other Name: FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin)
  • Drug: Gemcitabine
    Gemcitabine administered IV
    Other Names:
    • Gemzar
    • LY188011
  • 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.
    Interventions:
    • Drug: LY2090314
    • Drug: Gemcitabine
  • 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.
    Interventions:
    • Drug: LY2090314
    • Drug: FOLFOX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2017
May 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559 1-317-615-4559
United States
 
NCT01632306
14453, I2H-MC-JWYD
No
Eli Lilly and Company
Eli Lilly and Company
Mayo Clinic
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
Eli Lilly and Company
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP