Clinical Trials for Mesothelioma Patients: NGR-hTNF as Single Agent Outcomes Measures

Read about the outcomes measures in a current clinical trial being conducted to study NGR-hTNF as a single agent in patients who have been diagnosed with mesothelioma. At this time, the study is only being conducted in Italy. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

Primary Outcome Measures:
Antitumor activity defined as progression free survival (PFS) [ Time Frame: during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Tumor Growth Control Rate (TGCR) according to RECIST criteria

Overall survival (OS) [ Time Frame: during the study ] [ Designated as safety issue: No ]

Recruitment Information:
Recruitment Status: Recruiting
Enrollment: 39
Study Start Date: May 2007
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Intervention Details:
Drug: NGR-hTNF; iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

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.

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