An Open Label Study of Oral Enzastaurin in Participants With Cancer

NCT ID: NCT00309140

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enzastaurin

Group Type: EXPERIMENTAL

enzastaurin

Intervention Type: 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

Interventions

enzastaurin

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

Intervention Type: DRUG

Other Intervention Names

LY317615

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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, United States

Countries

United States

Other Identifiers

H6Q-MC-S001

Identifier Type: OTHER

Identifier Source: secondary_id

10287

Identifier Type: -

Identifier Source: org_study_id