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:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01632306
First received: June 28, 2012
Last updated: March 28, 2016
Last verified: March 2016

June 28, 2012
March 28, 2016
March 2013
June 2015   (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
  • Drug: Nab-paclitaxel
    Nab-paclitaxel administered IV
  • 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.
    Interventions:
    • Drug: LY2090314
    • Drug: Gemcitabine
  • 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.
    Interventions:
    • Drug: LY2090314
    • Drug: FOLFOX
  • 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.
    Interventions:
    • Drug: LY2090314
    • Drug: Gemcitabine
    • Drug: Nab-paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
June 2015
June 2015   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01632306
14453, I2H-MC-JWYD
No
Not Provided
Not Provided
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
March 2016

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