A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma
- Conditions
- Sarcoma, Soft Tissue
- Interventions
- Drug: LY573636-sodium
- Registration Number
- NCT00490451
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The primary purpose of the study is to estimate the time from the first dose of LY573636-sodium (hereafter referred to as LY573636) to the date your physician determines that your disease has progressed or worsened.
- Detailed Description
Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 21 days or 28 days depending on their target dose. Radiological 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 42 days or 56 days (every other cycle).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Diagnosis of soft tissue sarcoma that is unresectable or metastatic
- Have received one or two (but no more than two) prior treatment regimens for metastatic soft tissue sarcoma, one of which must have included doxorubicin (adriamycin).
- Must have stopped all previous treatments for cancer, including chemotherapy, radiation therapy or other investigational treatments for cancer for at least 30 days
- Participants with primary bone sarcoma (for example osteosarcoma, Ewing's sarcoma, chondrosarcoma), gastrointestinal stromal tumor (GIST) and Kaposi's sarcoma
- Serious pre-existing medical problems (as determined by your doctor)
- Have received more than two previous systemic treatment regimens for unresectable or metastatic soft tissue sarcoma
- Have a second primary cancer (unless cancer-free for more than 2 years)
- Active treatment with Warfarin (Coumadin)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LY573636 LY573636-sodium -
- Primary Outcome Measures
Name Time Method Progression-Free Survival First treatment dose to measured progressive disease or death from any cause up to 15.57 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 the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Complete Response or Partial Response (Objective Response Rate) First treatment dose to measured progressive disease or death due to any cause up to 15.57 months Objective response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate) First treatment dose to measured progressive disease or death due to any cause up to 15.57 months Clinical Benefit Rate = (CR + PR + SD)/N as classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0), 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.
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 Predose up to 2 hours postdose in Cycles 1 and 2 (21- or 28-day cycle) Duration of Stable Disease (SD) Time from documented SD or better to first date of progressive disease up to 15.57 months Duration of SD is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every other cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (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.
Number of Participants With Adverse Events (Safety) First treatment dose up to 26.51 months Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.
Overall Survival Time First treatment dose to death due to any cause up to 26.51 months Defined as the time from date of first dose to the date of death due to any cause.
Duration of Overall Objective Response Time of response to progressive disease or death up to 15.57 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 of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.
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.
🇪🇸Madrid, Spain