Clinical Trials for Mesothelioma Patients: Vandetanib Outcome Measures
Read about the outcome measures for this current clinical trial being conducted to study the effects of Vandetanib on patients who have been diagnosed with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only. At this time, this study is only being conducted in Germany and Switzerland.
Primary Outcome Measures:
To evaluate the efficacy of vandetanib compared with vinorelbine by estimating the Overall Disease Control Rate (DCR=CR+PR+SD) [Time Frame: Assessed from baseline to week 12] [Designated as safety issue: No]
Secondary Outcome Measures:
To estimate the Overall Objective Response Rate (ORR=CR+PR), Progression-Free Survival (PSF) and Overall Survival (OS). [ Time Frame: time to progression and death ] [ Designated as safety issue: No ]
To further characterise the safety profile of vandetanib. Quality of life over time [ Time Frame: assessed from baseline to week 12 ] [ Designated as safety issue: No ]
Recruitment Information
Recruitment Status: Recruiting
Enrollment: 66
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms and Assigned Interventions:
1: Active Comparator: Vinorelbine; Drug: Vinorelbine
2: Experimental Vandetanib: Drug: Vandetanib once daily oral dose
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Patient inclusion criteria for Vandetanib drug study on mesothelioma