An Open Label Study of Oral Enzastaurin in Participants With Cancer

Cancer Clinical Trial

Official title:

An Open-Label Study of Oral Enzastaurin HCl in Patients With Advanced or Metastatic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309140
• Other study ID #: 10287
• Secondary ID: H6Q-MC-S001
• Status: Completed
• Phase: Phase 2
• Start date: March 2006
• Est. completion date: July 2009

Study information

• Verified date: June 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Disease Progression (Time to Documented Tumor Activity)	Time to disease progression was defined as the time in months from study enrollment to the first date of progressive disease. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease was defined as having at least a 20% increase in sum of the longest diameter of target lesions. Time to disease progression was censored at the date of the last follow-up for participants who did not experience progressive disease, death, or their disease status was unknown.	Baseline through study completion (up to 26 months and 30-day safety follow-up)
Secondary	Percentage of Participants With Best Overall Response (Documented Antitumor Activity)	Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response was defined as the disappearance of all target lesions. Partial Response was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease was defined as having at least a 20% increase in sum of longest diameter of target lesions. Stable Disease was defined as small changes that did not meet the above criteria. Also, reported were unknown and missing responses. Percentage of participants was calculated as the total number of participants affected divided by the number of participants analyzed then multiplied by 100.	Baseline through study completion (up to 26 months and 30-day safety follow-up)

External Links

•   Lilly Clinical Trial Registry