drugset / Trial / NCT00718484

A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-tissue Sarcoma

NCT00718484

Phase 2 Unknown 67 enrolled Alaunos Therapeutics
RandomizedCrossoverOpen-labelTreatment

Summary

This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.

Timeline

Start
2008-08
Primary completion
2012-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 75 mg/m2 Intravenous
Subject Palifosfamide Small molecule 150 mg/m2 Intravenous

Indications