NCT00490451

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-06-22
• Last updated: 2019-09-18
• Results posted: 2018-05-02

Locations

13 sites across 3 countries: United States, Argentina, Spain