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

Phase 4
Not Enrolling
Breast Cancer, Endometrial Cancer, Ovarian Cancer

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Trial Information

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

To allow continued treatment of patients who exhibited clinical benefit from arzoxifene

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


United States: Food and Drug Administration

Study ID:




Start Date:

January 2001

Completion Date:

April 2007

Related Keywords:

  • Breast Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Adenoma



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  77030