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

Phase 3

Completed

• Conditions: Soft Tissue Sarcoma
• Interventions: Drug: doxorubicin in combination with palifosfamide-tris; Drug: doxorubicin in combination with placebo

• Registration Number: NCT01168791
• Lead Sponsor: Alaunos Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-23
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
doxorubicin plus palifosfamide-tris	doxorubicin in combination with palifosfamide-tris	-
doxorubicin plus placebo	doxorubicin in combination with placebo	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival followed by Overall Survival	assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (78)

Arizona Oncology Associates; 🇺🇸 Phoenix, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California, Irvine; 🇺🇸 Orange, California, United States

Sarcoma Oncology Center; 🇺🇸 Santa Monica, California, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Rocky Mountain Cancer Centers; 🇺🇸 Denver, Colorado, United States

Medical Oncology Hematology Consultants; 🇺🇸 Newark, Delaware, United States

MedStar Research Institute; 🇺🇸 Washington, District of Columbia, United States

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