Spots Global Cancer Trial Database for Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC)

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Trial Identification

Brief Title: Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC)

Official Title: NGR006: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Colorectal Cancer (CRC), Previously Treated With Fluoropyrimidine, Oxaliplatin and Irinotecan Based Regimens

Study ID: NCT00483080

Conditions

Colorectal Cancer (CRC)

Interventions

NGR-hTNF

Study Description

Brief Summary: The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic colorectal cancer 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 colorectal cancer (CRC), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, that will be conducted using Simon's two-stage design method.