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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY573636-sodium

Group Type EXPERIMENTAL

LY573636-sodium

Intervention Type DRUG

Dose is adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met

Interventions

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LY573636-sodium

Dose is adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met

Intervention Type DRUG

Other Intervention Names

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tasisulam

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No