Status:
COMPLETED
An Open Label Study of Oral Enzastaurin in Participants With Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Neoplasms
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00309140
Start Date
March 1 2006
End Date
July 1 2009
Last Update
June 26 2020
Active Locations (1)
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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, United States, 85351