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
  Purpose

Enzastaurin given daily to patients with colorectal cancer who have Stage 4 disease and have not received prior chemotherapy for advanced colorectal cancer


Condition Intervention Phase
Colonic Neoplasms
Drug: Enzastaurin HCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Oral Enzastaurin HCl in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: August 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Enzastaurin HCl
    1200 mg loading dose then 500 mg, oral, daily, up to six 28 day cycles
    Other Name: LY317615
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192114

Locations
Denmark
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Odense, Denmark, 5000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vejle, Denmark, 7100
Sweden
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Uppsala, Sweden, 75185
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00192114     History of Changes
Other Study ID Numbers: 9098, H6Q-MC-JCAR
Study First Received: September 14, 2005
Last Updated: October 5, 2009
Health Authority: Sweden: Medical Products Agency
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 29, 2014