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Brief Title: A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-tissue Sarcoma
Official Title: A Phase II Multicenter, Parallel Group, Randomized Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Subjects With Unresectable or Metastatic Soft-tissue Sarcoma
Study ID: NCT00718484
Brief Summary: This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Santa Monica, California, United States
, Washington, District of Columbia, United States
, Tampa, Florida, United States
, Coeur d'Alene, Idaho, United States
, Chicago, Illinois, United States
, Park Ridge, Illinois, United States
, Iowa city, Iowa, United States
, Lenaxa, Kansas, United States
, Albuquerque, New Mexico, United States
, New York, New York, United States
, Durham, North Carolina, United States
, Portland, Oregon, United States
, Philadelphia, Pennsylvania, United States
, Memphis, Tennessee, United States
, Nashville, Tennessee, United States
, San Antonio, Texas, United States
, Salt Lake City, Utah, United States
, Seattle, Washington, United States
, Milan, , Italy
, Padova, , Italy
, Torino, , Italy
, Cluj-Napoca, , Romania
, Lasi, , Romania
Name: Jonathan J Lewis, MD, PhD
Affiliation: ZIOPHARM Oncology, Inc
Role: STUDY_DIRECTOR