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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190697
First received: September 12, 2005
Last updated: May 23, 2007
Last verified: May 2007

September 12, 2005
May 23, 2007
January 2001
Not Provided
To allow continued treatment of patients who exhibited clinical benefit from arzoxifene
Same as current
Complete list of historical versions of study NCT00190697 on ClinicalTrials.gov Archive Site
To collect long-term safety data on arzoxifene use in advanced cancer patients
Same as current
Not Provided
Not Provided
 
A Study of LY353381 (Arzoxifene) for Patients Who Benefitted From This Drug in Other Oncology Trials and Wished to Continue Treatment
Continuation of Treatment and Monitoring of Safety in Patients Treated With LY353381 for Advanced Cancer

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Endometrial Cancer
  • Ovarian Cancer
Drug: arzoxifene
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2007
Not Provided

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.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00190697
5234, H4Z-MC-JWXM
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP