A Study of LY573636-sodium in Patients With Metastatic Breast Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: LY573636-sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992225

12265

H8K-MC-JZAL (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636-sodium for metastatic breast cancer.

Full description

Patient will receive a 2-hour intravenous infusion of study drug (LY573636-sodium) once every 28 days. Radiologic imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer.
• Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. Patients who have received whole-brain radiation must wait 90 days.

Exclusion criteria

• Serious pre-existing medical condition.
• Have active central nervous system or leptomeningeal metastasis.
• Current hematologic malignancies, acute or chronic leukemia.
• Receiving Warfarin (Coumadin).
• Have a history of radiation therapy involving more than 25% of the bone marrow.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

LY573636-sodium

Experimental group

Treatment:

Drug: LY573636-sodium