An Open Label Study of Oral Enzastaurin in Patients 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. Identifier: NCT00309140
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : June 2, 2010
Information provided by:
Eli Lilly and Company

Brief Summary:

This study will collect further basic safety data on patients 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 patients 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
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
Primary Completion Date : July 2009
Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: A Drug: enzastaurin
500 mg, oral, daily, six 42 day cycles
Other Name: LY317615

Primary Outcome Measures :
  1. This study will collect basic safety data on patients cancer treated with enzastaurin. [ Time Frame: every cycle ]

Secondary Outcome Measures :
  1. This study will document antitumor activity that may be observed with enzastaurin. [ Time Frame: baseline to measured progressive disease ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • You must have previously participated in and finished study JCAV, 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 patients 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, patients 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. Patients 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.

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 identifier (NCT number): NCT00309140

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
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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00309140     History of Changes
Other Study ID Numbers: 10287
H6Q-MC-S001 ( Other Identifier: Eli Lilly and Company )
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: May 2010