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Brief Title: Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma
Official Title: NGR010: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Previously Treated With no More Than One Systemic Therapeutic Regimen
Study ID: NCT00484276
Brief Summary: The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic malignant pleural mesothelioma patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.
Detailed Description: This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen , that will be conducted using Simon's two-stage design method.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Istituto Clinico Humanitas, Rozzano, Milan, Italy
Fondazione San Raffaele del Monte Tabor, Milan, , Italy
Istituto Europeo Oncologico, Milan, , Italy
Istituto Nazionale dei Tumori, Milan, , Italy
Name: Antonio Lambiase, MD
Affiliation: AGC Biologics S.p.A.
Role: STUDY_DIRECTOR