NCT00490451

A Phase 2 Study of LY573636-Sodium Administered as Second-line or Third-line Treatment in Patients With Unresectable or Metastatic Soft Tissue Sarcoma

Completed Phase 2 Results posted Last updated 6 September 2019

What this trial tests

Phase 2 trial testing LY573636-sodium in Sarcoma, Soft Tissue in 101 participants. Completed in 1 February 2010.

Timeline

1 August 2007

Primary endpoint
1 February 2010

1 February 2010

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	101
Start date	1 August 2007
Primary completion	1 February 2010
Estimated completion	1 February 2010
Sites	13 locations across United States, Argentina, Spain

Drugs / interventions tested

• LY573636-sodium — full drug profile →

Conditions studied

• Sarcoma, Soft Tissue — all drugs for Sarcoma, Soft Tissue →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Sarcoma, Soft Tissue. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. RNA-binding protein 39: a promising therapeutic target for cancer.
   Xu C, Chen X, Zhang X, Zhao D, et al · · 2021 · cited 57× · PMID 34389703 · DOI 10.1038/s41420-021-00598-7
2. Targeting RNA splicing modulation: new perspectives for anticancer strategy?
   Lv X, Sun X, Gao Y, Song X, et al · · 2025 · cited 18× · PMID 39885614 · DOI 10.1186/s13046-025-03279-w