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A Study for Patients With Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00839332
First received: February 6, 2009
Last updated: April 14, 2014
Last verified: April 2014

February 6, 2009
April 14, 2014
March 2009
February 2013   (final data collection date for primary outcome measure)
  • Phase 1: Determine the maximum tolerated dose for LY2603618 when administered after gemcitabine. [ Time Frame: Time of first dose until 28 days post dose ] [ Designated as safety issue: Yes ]
  • Phase 2: overall survival [ Time Frame: Baseline to date of death ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00839332 on ClinicalTrials.gov Archive Site
  • Cmax of gemcitabine and LY2603618 [ Time Frame: Phase 1: During cycles 1 and 2 Phase 2: During cycle 1 ] [ Designated as safety issue: No ]
  • Overall tumor response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Electrocardiogram QTc prolongation [ Time Frame: Baseline and during Cycle 1 of both Phase 1 and Phase 2 for patients receiving LY2603618 ] [ Designated as safety issue: Yes ]
  • Time to disease progression [ Time Frame: Baseline to objective progression ] [ Designated as safety issue: No ]
  • Response rate in tumor size at 8 weeks and the relationship with overall survival [ Time Frame: Baseline to date of confirmed response and date of death from any cause ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: baseline to time of discontinuing gemcitabine and/or LY2603618 or baseline to time of starting of new therapy after discontinuing study treatment ] [ Designated as safety issue: No ]
  • AUC of gemcitabine and LY2603618 [ Time Frame: Phase 1: During cycles 1 and 2 Phase 2: During cycle 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study for Patients With Pancreatic Cancer
A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer

The purpose of the Phase 1 portion of this study is to determine the safe dose of LY2603618 when given 24 hours after gemcitabine. This dose will then be used for the Phase 2 portion of the study. The Phase 2 portion of the study will evaluate whether LY2603618 when administered 24 hours after gemcitabine therapy is an effective treatment for patients with pancreatic cancer.

Phase 1 will be a dose escalation of doses 70 mg/m2 to 300 mg/m2 divided into 6 cohorts. Each patient will be assigned to a single cohort with no intrapatient dose escalation. Patients will received gemcitabine on days 1, 8, and 15 followed by LY2603618 on days 2, 9, and 16 of each 28 day cycle. The phase 1 portion will enroll approximately 26 patients total to determine the maximum tolerated dose to be carried into the phase 2 portion of the study.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Neoplasms
  • Drug: LY2603618
    70-300 mg/m2 intravenous administered once per week for 3 weeks followed by 1 week of rest, repeating every 28 days for a minimum of 2 cycles and until disease progression
  • Drug: Gemcitabine
    1000 mg/m2 intravenous administered once per week for 3 weeks followed by 1 week of rest, repeating every 28 days for a minimum of 2 cycles continuing until disease progression
    Other Names:
    • Gemzar
    • LY188011
  • Experimental: LY2603618/gemcitabine
    Interventions:
    • Drug: LY2603618
    • Drug: Gemcitabine
  • Active Comparator: Gemcitabine
    Intervention: Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
December 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with cancer that is metastatic and/or advanced during Phase 1
  • Diagnosed with pancreatic cancer that is metastatic and not amenable to surgery
  • Must be 18 years of age
  • Adequate hematological, liver, and renal functions
  • ECOG status 0-2

Exclusion Criteria:

  • Known hypersensitivity to gemcitabine
  • Pregnant or lactating females or refusal to use medically approved contraceptive precautions
  • Had prior treatment with radiotherapy involving more than 25% of marrow producing area
  • Have received treatment in the last 30 days with a drug which has not received regulatory approval for any indication at the time of study entry
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Italy,   Netherlands,   Romania,   Spain
 
NCT00839332
12096, I2I-MC-JMMC
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
April 2014

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