Enzastaurin For Breast Cancer Patients Who Previously Received an Anthracycline and a Taxane Chemotherapy

Breast Neoplasms Clinical Trial

Official title:

A Phase II Study of Oral Enzastaurin in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane-Containing Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386087
• Other study ID #: 10517
• Secondary ID: H6Q-MC-S015
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2006
• Last updated: June 5, 2008
• Start date: November 2006
• Est. completion date: September 2007

Study information

• Verified date: April 2008
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of metastatic breast cancer or recurrent breast cancer where surgery can not be done for curative intent

• Have received prior therapy with an anthracycline (class of drugs) and a taxane (class of drugs).

• Tumors must not be positive for HER2, but if positive, the treatment plan should not include further treatment with the drug Herceptin.

• Disease that can be definitely measured on Cat Scans or other radiological tests.

• May have received high dose chemotherapy for autologous stem cell support greater than or equal to 6 months of starting this study.

Exclusion Criteria:

• More than 2 chemotherapy regimens for metastatic or locally recurrent disease.

• Have brain cancer from breast cancer

• Pregnant or breastfeeding

• Have an inability to swallow tablets

• Within 6 months have had a serious heart condition

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Enzastaurin Hydrochloride

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.	Boston	Massachusetts
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.	Indianapolis	Indiana
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.	Newark	Delaware
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.	South Bend	Indiana

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	To determine the effects of enzastaurin in the treatment of patients with breast cancer by measuring its ability to reduce the size of the tumor or prevent further increases in tumor size.
Secondary	To evaluate the length of time that enzastaurin is able to effect control of the disease.
Secondary	To evaluate the side effects of enzastaurin in patients with breast cancer
Secondary	To determine whether changes in laboratory tests of patients treated with enzastaurin is associated with the response of their tumors to the drug.

External Links

•   Hoosier Oncology Group
•   Lilly Clinical Trial Registry