Enzastaurin for Patients With Metastatic Colorectal Cancer

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. Identifier: NCT00192114
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : October 7, 2009
Information provided by:
Eli Lilly and Company

September 14, 2005
September 19, 2005
October 7, 2009
August 2005
March 2008   (Final data collection date for primary outcome measure)
Progression free survival [ Time Frame: baseline to 6 months ]
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Complete list of historical versions of study NCT00192114 on Archive Site
  • Objective response rate [ Time Frame: baseline to measured progressive disease ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ]
  • Progression free survival [ Time Frame: baseline to measured progressive disease ]
  • Duration of stable disease [ Time Frame: time from stable disease to measured progressive disease ]
  • Time to response [ Time Frame: baseline to date of confirmed response ]
  • Duration of response [ Time Frame: time from response to progressive disease ]
  • Safety [ Time Frame: each cycle ]
  • QTc interval [ Time Frame: baseline, cycle 1, cycle 2 ]
  • Pharmacokinetics [ Time Frame: cycle 1, 2 and 3 ]
  • Evaluate carcinoembryonic antigen (CEA) response in patients receiving enzastaurin [ Time Frame: baseline, each cycle ]
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Enzastaurin for Patients With Metastatic Colorectal Cancer
A Phase 2 Study of Oral Enzastaurin HCl in Patients With Metastatic Colorectal Cancer
Enzastaurin given daily to patients with colorectal cancer who have Stage 4 disease and have not received prior chemotherapy for advanced colorectal cancer
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colonic Neoplasms
Drug: Enzastaurin HCl
1200 mg loading dose then 500 mg, oral, daily, up to six 28 day cycles
Other Name: LY317615
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosed with colorectal cancer that is advanced or metastatic (has spread to other parts of the body); able to visit the doctor's office every 28 days for at least 6 months; able to swallow tablets

Exclusion Criteria:

  • women cannot be pregnant or breastfeeding; no history of significant heart disease or any other significant medical problems as determined by the patient's physician
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Denmark,   Sweden
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Chief Medical Officer, Eli Lilly
Eli Lilly and Company
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 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