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

Study Overview
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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.

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).

Official Title
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Phase 2 Evaluation of a Once Every 28 Days Dosing Regimen for LY573636-sodium in Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: LY573636-sodium


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY573636-sodium<br> | Drug: LY573636-sodium<br>* 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<br>* Other names: tasisulam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an Objective Overall Response | Objective overall response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. It is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | Baseline to measured progressive disease or death from any cause up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | Baseline to measured progressive disease or death from any cause up to 12 months | 
| Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)] | Clinical Benefit Rate = [(CR) + (PR) + Stable Disease (SD)] of at least 4 cycles/N as classified by the investigator according to the RECIST guidelines, where N = total number of participants with at least one dose of study drug. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. | Baseline to measured progressive disease or death from any cause up to 12 months | 
| Duration of Overall Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to RECIST guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. | Time of response to progressive disease or death up to 12 months | 
| Duration of Stable Disease | Duration of stable disease (SD) is defined from date of documented SD to first date of progressive disease (PD) or death from any cause (assessed every other cycle during study therapy, or every 2 months during post-therapy). SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | Time from documented Stable Disease (SD) to first date of progressive disease or death from any cause up to 12 months | 
| The Percentage of Participants With Exposures in the Target Range | Exposure is the amount of drug the body sees in a period of time. Target range is an exposure thought to offer the optimal balance of safety and efficacy based on prior research. | After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle) | 
| Maximum Concentration (Cmax) |  | After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic