Brief Title
A Study of LY353381 (Arzoxifene) for Patients Who Benefitted From This Drug in Other Oncology Trials and Wished to Continue Treatment
Official Title
Continuation of Treatment and Monitoring of Safety in Patients Treated With LY353381 for Advanced Cancer
Brief 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
To allow continued treatment of patients who exhibited clinical benefit from arzoxifene
Secondary Outcome
To collect long-term safety data on arzoxifene use in advanced cancer patients
Condition
Breast Cancer
Intervention
arzoxifene
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
70
Start Date
January 2001
Completion Date
April 2007
Eligibility Criteria
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.
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Call 1-877-285-4559 (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00190697
Organization ID
5234
Secondary IDs
H4Z-MC-JWXM
Study Sponsor
Eli Lilly and Company
Study Sponsor
Call 1-877-285-4559 (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Eli Lilly and Company
Verification Date
May 2007