NCT Number: NCT00992225
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
For additional information regarding investigative sites for this trial, contact 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 speak with your personal physician., Tampa, Florida, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: tasisulam
Time frame: Baseline to measured progressive disease or death from any cause up to 12 months
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.
Time frame: Baseline to measured progressive disease or death from any cause up to 12 months
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.
Time frame: Baseline to measured progressive disease or death from any cause up to 12 months
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.
Time frame: Time of response to progressive disease or death up to 12 months
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 frame: Time from documented Stable Disease (SD) to first date of progressive disease or death from any cause up to 12 months
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 frame: After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)
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.
Time frame: After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)]
Eli Lilly and Company
Industry
Phase 2 Evaluation of a Once Every 28 Days Dosing Regimen for LY573636-sodium in Patients With Metastatic Breast Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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