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Brief Title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma
Official Title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy
Study ID: NCT01011439
Brief Summary: The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.
Detailed Description: The Simon's optimal 2 stage design is adopted for this single-arm, open-label, multicenter phase II clinical trial of PHA-848125AC administered to patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy (only one prior systemic therapy allowed). The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of patients with thymic carcinoma who have already exploited one chemotherapy option. The primary end point for this study is a progression free survival rate of 3 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
TGen Clinical Research Services at Scottsdale Healthcare, Scottsdale, Arizona, United States
NIH, Center for Cancer Research, Medical Oncology, Bethesda, Maryland, United States
Hopital Larrey, Toulouse Cedex, , France
Institut de cancerologie Gustave Roussy, Villejuif Cedex, , France
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, (mi), Italy
Azienda Ospedaliera San Luigi Gonzaga, Orbassano, , Italy
Name: Glen Weiss, MD
Affiliation: Scottsdale Clinical Research Institute, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Benjamin Besse, MD
Affiliation: Institut Gustave Roussy, Villejuif, France
Role: PRINCIPAL_INVESTIGATOR
Name: Julien Mazières, MD
Affiliation: Hopital Larrey CHU, Toulouse, France
Role: PRINCIPAL_INVESTIGATOR
Name: Silvia Novello, MD
Affiliation: Ospedale San Luigi Gonzaga, Orbassano, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Arun Rajan, MD.
Affiliation: National Cancer Institute (NCI)
Role: PRINCIPAL_INVESTIGATOR
Name: Marina C Garassino, MD
Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Role: PRINCIPAL_INVESTIGATOR