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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00490451
First received: June 20, 2007
Last updated: December 9, 2010
Last verified: December 2010

June 20, 2007
December 9, 2010
August 2007
February 2010   (final data collection date for primary outcome measure)
Progression-free survival. [ Time Frame: Baseline to measured progressive disease. ] [ Designated as safety issue: No ]
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
  • Objective response rate (complete response + partial response). [ Time Frame: Baseline to measured progressive disease. ] [ Designated as safety issue: No ]
  • Clinical benefit rate (complete response + partial response + stable disease). [ Time Frame: Baseline to measured progressive disease. ] [ Designated as safety issue: No ]
  • Pharmacokinetics. [ Time Frame: Before and after each dose (Cycles 1 through 6). ] [ Designated as safety issue: No ]
  • Overall survival time. [ Time Frame: Baseline to date of death from any cause. ] [ Designated as safety issue: Yes ]
  • Duration of overall objective response. [ Time Frame: From time of response to time of measured progressive disease. ] [ Designated as safety issue: No ]
  • Duration of stable disease. [ Time Frame: Time from stable disease to time of measured progressive disease. ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Every cycle. ] [ Designated as safety issue: Yes ]
  • 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 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma, Soft Tissue
Drug: LY573636
LY573636 dose is dependent on patient's height, weight, and gender to target a specific Cmax. LY573636 is administered every 21 or 28 days until disease progression or other criteria for patient discontinuation are met.
Other Name: tasisulam
Experimental: A
Intervention: Drug: LY573636
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
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:

  • Patients with primary bone sarcoma (e.g. 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 that 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain,   Argentina
 
NCT00490451
10408, H8K-MC-JZAD, H8K-MC-JZAD(a)
No
Chief Medical Officer, 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
December 2010

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