drugset / Trial / NCT01168791

Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma

NCT01168791

Phase 3 Completed 447 enrolled Alaunos Therapeutics
RandomizedParallel-groupTriple-blindTreatment

Summary

This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).

Timeline

Start
2010-07
Primary completion
2013-03
Completion
2013-03

Drugs

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

Indications