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An Open Label Study of Oral Enzastaurin in Participants With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00309140
Recruitment Status : Completed
First Posted : March 31, 2006
Results First Posted : June 26, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.


Condition or disease Intervention/treatment Phase
Neoplasms Cancer Drug: enzastaurin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Oral Enzastaurin HCl in Patients With Advanced or Metastatic Malignancies
Study Start Date : March 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: Enzastaurin 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
Other Name: LY317615


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs [ Time Frame: Baseline through study completion (up to 26 months and 30-day safety follow-up) ]
    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.


Secondary Outcome Measures :
  1. Time to Disease Progression (Time to Documented Tumor Activity) [ Time Frame: Baseline through study completion (up to 26 months and 30-day safety follow-up) ]
    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.

  2. Percentage of Participants With Best Overall Response (Documented Antitumor Activity) [ Time Frame: Baseline through study completion (up to 26 months and 30-day safety follow-up) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309140


Locations
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United States, Arizona
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00309140    
Other Study ID Numbers: 10287
H6Q-MC-S001 ( Other Identifier: Eli Lilly and Company )
First Posted: March 31, 2006    Key Record Dates
Results First Posted: June 26, 2020
Last Update Posted: June 26, 2020
Last Verified: June 2020