NCT01168791

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

A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 447 (actual)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	doxorubicin in combination with palifosfamide-tris	palifosfamide-tris: 150 mg/m2 3 days every 21 days for a maximum of 6 cycles. doxorubicin: 75 mg/m2 1 day every 21 days for a maximum of 6 cycles.
DRUG	doxorubicin in combination with placebo	doxorubicin: 75 mg/m2 of doxorubicin 1 day every 21 days for a maximum of 6 cycles. placebo: 250 mL of normal saline 3 days every 21 days for a maximum of 6 cycles.

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-07-23
• Last updated: 2013-07-18

Locations

161 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, Germany, Guatemala, India, Israel, Italy, Panama, Poland, Romania, Russia, Singapore, Spain, United Kingdom