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.

Alaunos Therapeutics78 sites in 3 countries447 target enrollmentJuly 2010

ConditionsSoft Tissue Sarcoma

Interventionsdoxorubicin in combination with palifosfamide-tris doxorubicin in combination with placebo

Drugsdoxorubicin in combination with palifosfamide-tris doxorubicin in combination with placebo

Overview

Phase: Phase 3
Intervention: doxorubicin in combination with palifosfamide-tris
Conditions: Soft Tissue Sarcoma
Sponsor: Alaunos Therapeutics
Enrollment: 447
Locations: 78
Primary Endpoint: Progression Free Survival followed by Overall Survival
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

March 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alaunos Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

doxorubicin plus palifosfamide-tris

Intervention: doxorubicin in combination with palifosfamide-tris

doxorubicin plus placebo

Intervention: doxorubicin in combination with placebo

Outcomes

Primary Outcomes

Progression Free Survival followed by Overall Survival

Time Frame: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death

Secondary Outcomes

Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires(assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death)
Safety and Tolerability as evaluated using CTCAE v 4.0(22 weeks)