Enzastaurin for Patients With Metastatic Colorectal Cancer

NCT00192114 | Completed Phase 2 Results

• 2 other identifiers: 9098H6Q-MC-JCAR
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Progression Free Survival (PFS) at 6 Months

  PFS defined as time from date of first dose of enzastaurin to first date of documented progressive disease (PD) or date of death (any cause), whichever occurred first. Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) PD defined as ≥20% increase in sum of the longest diameter (LD) of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of ≥1 new lesions. Participants not known to have died as of data-inclusion cut-off date and who did not have PD, PFS was censored at date of last progression-free disease assessment prior to date of any post discontinuation anticancer therapy. Participants who took any subsequent systemic anticancer therapy prior to PD or death, PFS was censored at date of last progression-free disease assessment prior to the date of any post discontinuation anticancer therapy. PFS at 6 months = participants who were progression free and alive at 6 months divided by the number of treated participants x 100.

  Baseline to 6 months

Secondary Outcomes (10)

• Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

  Baseline to measured progressive disease (PD) up to 24 months

• Overall Survival (OS)

  Baseline to date of death from any cause up to 24 months

• Progression Free Survival (PFS)

  Baseline to measured PD up to 9 months

• Duration of Stable Disease (SD)

  Time from SD to measured PD up to 9 months

• Time to Treatment Response

  Baseline to date of confirmed response up to 24 months

Other Outcomes (1)

• Change From Baseline in Vascular Endothelial Growth Factor (VEGF) to Cycle 2 and Cycle 3

  Baseline, Cycle 2 and Cycle 3 (28-day cycles)

Study Arms (1)

Enzastaurin HCl

EXPERIMENTAL

Drug: Enzastaurin HCl

Interventions

Enzastaurin HCl DRUG

1200 milligrams (mg) loading dose orally, then 500 mg, orally, daily, up to six 28-day cycles.

Also known as: LY317615

Enzastaurin HCl

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• women cannot be pregnant or breastfeeding; no history of significant heart disease or any other significant medical problems as determined by the participant's physician

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

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, 5000, Denmark

Location

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, 7100, Denmark

Location

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, 75185, Sweden

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

enzastaurin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: August 6, 2020
• Results First Posted: August 6, 2020

Record last verified: 2020-07

Locations

SE (1); DK (2)