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Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Patients With Advanced or Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00267020
First received: December 16, 2005
Last updated: October 5, 2009
Last verified: October 2009
History of Changes

December 16, 2005
October 5, 2009
December 2005
May 2008   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: baseline to the date of death from any cause. ] [ Designated as safety issue: Yes ]
  • Overall survival will be measured from the date of randomization to the date of death from any cause.
  • Progression free survival will be measured from the date of randomization to the first date of documented progressive disease or death due to any cause.
Complete list of historical versions of study NCT00267020 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: baseline, each cycle, end of study ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Response will be measured by tumor measurement and lab sampling.
  • Quality of Life will be measured by questionnaire.
  • Toxicity will be measured by standard grading scales.
Not Provided
Not Provided
 
Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Patients With Advanced or Metastatic Pancreatic Cancer
A Randomized, Open-Label Phase 2 Study of 2 Regimens, Gemcitabine Plus Enzastaurin and Single-Agent Gemcitabine, in Patients With Locally Advanced or Metastatic Pancreatic Cancer

The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in patients with pancreatic cancer.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Neoplasm
  • Drug: enzastaurin
    1200 mg loading dose then 500 mg, oral, daily, six 28 day cycles
    Other Name: LY317615
  • Drug: gemcitabine
    1000 mg/m2, IV, days 1, 8 and 15 per cycle, six 28 day cycles
    Other Names:
    • LY188011
    • Gemzar
  • Experimental: A
    Interventions:
    • Drug: enzastaurin
    • Drug: gemcitabine
  • Active Comparator: B
    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
130
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of adenocarcinoma of the pancreas.
  • Pretreatment tumor specimen must be available.
  • No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for pancreatic cancer, including 5FU with radiation therapy.
  • Prior radiation allowed.
  • Ability to stop some types of anti-seizure medicines within 14 days of enrollment.

Exclusion Criteria:

  • Endocrine pancreatic tumor or ampullary cancer.
  • Central Nervous System metastases.
  • Inability to swallow tablets.
  • 10% or greater weight loss over the 6 weeks before study entry.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00267020
10463, H6Q-US-S002
Yes
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
October 2009

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