A Study of LY353381 (Arzoxifene) for Patients Who Benefitted From This Drug in Other Oncology Trials and Wished to Continue Treatment
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.
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.
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, Learn About Clinical Studies.
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
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 ClinicalTrials.gov identifier (NCT number): NCT00190697
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United States, Texas
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, United States, 77030
Sponsors and Collaborators
Eli Lilly and Company
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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)