An Open Label Study of Oral Enzastaurin in Patients With Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00309140
First received: March 29, 2006
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Neoplasms
Cancer
Drug: enzastaurin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of Oral Enzastaurin HCl in Patients With Advanced or Metastatic Malignancies

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Secondary Outcome Measures:
  • This study will document antitumor activity that may be observed with enzastaurin. [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: March 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: enzastaurin
500 mg, oral, daily, six 42 day cycles
Other Name: LY317615

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309140

Locations
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
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

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00309140     History of Changes
Other Study ID Numbers: 10287, H6Q-MC-S001
Study First Received: March 29, 2006
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014