A Study of LY353381 (Arzoxifene) for Patients Who Benefitted From This Drug in Other Oncology Trials and Wished to Continue Treatment

Breast Cancer Clinical Trial

Official title:

Continuation of Treatment and Monitoring of Safety in Patients Treated With LY353381 for Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190697
• Other study ID #: 5234
• Secondary ID: H4Z-MC-JWXM
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: May 23, 2007
• Start date: January 2001
• Est. completion date: April 2007

Study information

• Verified date: May 2007
• 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

Patients who were previously enrolled on the LY353381 arm of any LY353381 oncology trial could enroll in this "roll-over" study if they had exhibited clinical benefit from treatment and wished to continue on treatment. Patients were monitored for safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participation in a clinical trial of LY353381 that has met its main safety and efficacy objectives, and could otherwise close.

• Evidence of continuing benefit with LY353381 (eg. complete response, partial response or stable disease with no symptomatic or clinical evidence of disease progression).

• Adequate bone marrow reserve, liver and renal function, consistent with the previous LY353381 protocol, with no recent significant deterioration or metabolic condition that could affect patient safety or compliance with the protocol (eg, hypercalcemia).

• Written informed consent from patient.

• Childbearing potential either terminated by surgery, radiation, menopause, or attenuated by use of an intra-uterine contraceptive device or barrier method during and for 3 months after the trial.

Exclusion Criteria:

• No concurrent systemic therapy (immunotherapy, hormone therapy or chemotherapy) for cancer. Palliative radiotherapy is allowed (eg, for pain) as long as there is no evidence of disease progression. Investigational agents, other than LY353381, within the 4 weeks prior to this study enrollment and other SERMs are also not permitted.

• No concurrent use of oral contraceptives, GnRH agonists, or coumarin (warfarin).

• No serious concomitant systemic disorders incompatible with the study (at the discretion of investigator), including predisposition to thromboembolic disorder.

• Must not be pregnant or breast-feeding.

• Must not have a gap in treatment of more than 4 weeks between previous LY353381 study and enrollment in current study.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Endometrial Cancer
• Ovarian Cancer

Intervention

Drug:
• arzoxifene

Locations

Country	Name	City	State
United States	For information regarding investigative sites for this clinical trial, call 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 contact your personal physician	Houston	Texas

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 allow continued treatment of patients who exhibited clinical benefit from arzoxifene
Secondary	To collect long-term safety data on arzoxifene use in advanced cancer patients

External Links

•   Lilly Clinical Trial Registry