Enzastaurin for Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00192114
First received: September 14, 2005
Last updated: October 5, 2009
Last verified: October 2009

September 14, 2005
October 5, 2009
August 2005
March 2008   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00192114 on ClinicalTrials.gov Archive Site
  • Objective response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of stable disease [ Time Frame: time from stable disease to measured progressive disease ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: baseline to date of confirmed response ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: time from response to progressive disease ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
  • QTc interval [ Time Frame: baseline, cycle 1, cycle 2 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: cycle 1, 2 and 3 ] [ Designated as safety issue: No ]
  • Evaluate carcinoembryonic antigen (CEA) response in patients receiving enzastaurin [ Time Frame: baseline, each cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Sweden
 
NCT00192114
9098, H6Q-MC-JCAR
No
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 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