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A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00490451
Recruitment Status : Completed
First Posted : June 22, 2007
Results First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

June 20, 2007
June 22, 2007
March 17, 2018
May 2, 2018
May 2, 2018
August 2007
February 2010   (Final data collection date for primary outcome measure)
Progression-Free Survival [ Time Frame: 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.
Progression-free survival for patients who have received LY573636 after one or two prior systemic treatment regimens. CT-scans will be performed before the first dose and then after every other cycle of treatment. [ Time Frame: Patients will be evaluated for response every other cycle (approximately every 42 days). ]
Complete list of historical versions of study NCT00490451 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Complete Response or Partial Response (Objective Response Rate) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Predose up to 2 hours postdose in Cycles 1 and 2 (21- or 28-day cycle) ]
  • Overall Survival Time [ Time Frame: 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 Frame: 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.
  • Duration of Stable Disease (SD) [ Time Frame: 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) [ Time Frame: 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.
  • Objective response rate (complete response + partial response). [ Time Frame: Patients will be assessed for clinical progression at every visit and for response by CT-scans every other visit (~every 42 days). ]
  • Clinical benefit rate (complete response + partial response + stable disease). [ Time Frame: Patients will be assessed for clinical progression at every visit and for response by CT-scans every other visit (~every 42 days). ]
  • Pharmacokinetics. [ Time Frame: Samples will be collected before and after each dose (up to 6 cycles of treatment). Data will be reviewed every 3 months to determine if changes to the dosing regimen are needed to ensure patient safety. ]
  • Overall survival time. [ Time Frame: A post-treatment follow-up evaluation will be completed approximately 30 days following the last dose of study drug received. Patient disposition will then be assessed approximately every 2 months (60 days) until death or until the end of the study. ]
  • Duration of overall objective response and stable disease. [ Time Frame: Patients will be assessed for clinical progression at every visit and for response by CT-scans every other visit (~every 42 days). ]
  • Safety. [ Time Frame: Safety data will be monitored closely and reviewed every 3 months to determine if changes to the dosing regimen are needed to ensure patient safety. ]
Not Provided
Not Provided
 
A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma
A Phase 2 Study of LY573636-Sodium Administered as Second-line or Third-line Treatment in Patients With Unresectable or Metastatic Soft Tissue Sarcoma
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.
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).
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sarcoma, Soft Tissue
Drug: LY573636-sodium
LY573636 dose is dependent on patient's height, weight, and gender to target a specific maximum concentration (Cmax). LY573636 is administered intravenously every 21 or 28 days until disease progression or other criteria for patient discontinuation are met.
Other Name: Tasisulam
Experimental: LY573636
Intervention: Drug: LY573636-sodium
Ryan CW, Matias C, Agulnik M, Lopez-Pousa A, Williams C, de Alwis DP, Kaiser C, Miller MA, Ermisch S, Ilaria R Jr, Keohan ML. A phase II study of tasisulam sodium (LY573636 sodium) as second-line or third-line treatment for patients with unresectable or metastatic soft tissue sarcoma. Invest New Drugs. 2013 Feb;31(1):145-51. doi: 10.1007/s10637-012-9819-5. Epub 2012 Apr 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
50
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Spain,   United States
 
 
NCT00490451
10408
H8K-MC-JZAD ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP