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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
447
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.
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.
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
Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires
Time frame: 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
Time frame: 22 weeks
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Unnamed facility
Birmingham, Alabama, United States
Arizona Oncology Associates
Phoenix, Arizona, United States
Unnamed facility
Scottsdale, 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
Unnamed facility
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
Unnamed facility
Pomona, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
...and 151 more locations