An Open Label Study of Oral Enzastaurin in Participants With Cancer

NCT00309140 | Completed Phase 2 Results

• 2 other identifiers: 10287H6Q-MC-S001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public. The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli Lilly and Company and who may benefit from continued enzastaurin therapy.

Conditions

Neoplasms; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs

  Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report.

  Baseline through study completion (up to 26 months and 30-day safety follow-up)

Secondary Outcomes (2)

• Time to Disease Progression (Time to Documented Tumor Activity)

  Baseline through study completion (up to 26 months and 30-day safety follow-up)

• Percentage of Participants With Best Overall Response (Documented Antitumor Activity)

  Baseline through study completion (up to 26 months and 30-day safety follow-up)

Study Arms (1)

Enzastaurin

EXPERIMENTAL

Drug: enzastaurin

Interventions

enzastaurin DRUG

500 milligrams (mg), oral, daily, six 42-day cycle and subsequent cycles or until participants met study discontinuation criteria of progressive disease or unacceptable toxicity

Also known as: LY317615

Enzastaurin

Eligibility Criteria

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

You may qualify if:

• You must have previously participated in and finished Study H6Q-LC-JCAV (JCAV), Study H6Q-LC-JCAY (JCAY), or other enzastaurin clinical pharmacology and biopharmaceutics studies. If you have had any other cancer treatment (chemotherapy, radiation, anti-cancer hormone therapy), you must have completed it at least 4 weeks ago before you can enroll in this study.
• You must have a cancer for which no other therapy exists that can prolong your life. This may include participants with treated, stable brain cancer.
• You must have lesions (areas of cancer in your body) that your doctor can either measure or detect.
• You either must not be able to become pregnant, (because you've had surgery \["tubes tied" or hysterectomy\], you've gone through menopause, or you've had previous radiation for cancer that made you sterile) or your potential to become pregnant must be reduced by the use of an approved birth control method (including intrauterine or barrier devices) during and for 3 to 6 months following the study.
• You can be either male or female, and must be at least 18 years old.

You may not qualify if:

• You must not have received treatment within the last 30 days with a drug other than enzastaurin that is still experimental (this means it has not received approval to be prescribed, except in a clinical trial).
• You must not be pregnant or breastfeeding.
• You must not have central nervous system (CNS) tumors (tumors in your brain and spinal cord). (However, participants who have stable CNS tumors and are taking steroid medication may be included.)
• You must not have another serious disorder, including active infections that will interfere with your participation in the study.
• You must not have a second cancer in addition to your primary cancer. Participants with adequately treated skin cancer or who have had another cancer in the past, but have been cancer free for more than 2 years, are eligible.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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.

Sun City, Arizona, 85351, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Neoplasms

Interventions

enzastaurin

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 - 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: March 29, 2006
• First Posted: March 31, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 26, 2020
• Results First Posted: June 26, 2020

Record last verified: 2020-06

Locations

US (1)