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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: LY573636-sodium

• Registration Number: NCT00992225
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

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).

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Disposition First Submitted: 2011-08-09
• Disposition First Submitted QC: 2011-08-09
• Disposition First Posted: 2011-08-15
• Results First Submitted: 2018-03-17
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-18
• Last Update Submitted: 2018-06-18
• Results First Posted: 2018-07-17
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY573636-sodium	LY573636-sodium	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an Objective Overall Response	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)]	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.
Duration of Stable Disease	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.
The Percentage of Participants With Exposures in the Target Range	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.
Duration of Overall Response	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.
Progression-free Survival	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.
Maximum Concentration (Cmax)	After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)]

Trial Locations

Locations (1)

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.; 🇺🇸 Temple, Texas, United States