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Brief Title: Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy
Official Title: Phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy
Study ID: NCT01222767
Brief Summary: This is a phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis® (PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy to determine the antitumor activity of Zalypsis.
Detailed Description:
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sarcoma Oncology Center, Santa Monica, California, United States
St. Jude Children 's Research Hospital, Memphis, Tennessee, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Centre Léon Bérard, Lyon, , France
Istituto Ortopedici Rizzoli, Bologna, , Italy
Istituto Nazionale dei Tumori, Milan, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Name: Fariba Navid, MD
Affiliation: St. Jude Children 's Research Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Sant P Chawla, MD
Affiliation: Sarcoma Oncology Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jean Yves Blay, MD
Affiliation: Centre Leon Berard
Role: PRINCIPAL_INVESTIGATOR
Name: Stefano Ferrari, MD
Affiliation: Istituto Ortopedici Rizzoli
Role: PRINCIPAL_INVESTIGATOR
Name: Armando Santoro, Prof.
Affiliation: Istituto Clinico Humanitas
Role: PRINCIPAL_INVESTIGATOR
Name: Paolo Casali, MD
Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Role: PRINCIPAL_INVESTIGATOR
Name: Robin L. Jones, MD
Affiliation: Seattle Cancer Care Alliance
Role: PRINCIPAL_INVESTIGATOR