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A Study Is Conducted to Assess the Potential Clinical Benefit

Question 25

Multiple Choice

A study is conducted to assess the potential clinical benefit and treatment-related toxicities of tandutinib in combination with bevacizumab for patients with recurrent glioblastoma.  Forty-one recurrent, bevacizumab-naïve glioblastoma patients were recruited for the study.  Treatment consisted of tandutinib 500 mg twice daily and bevacizumab 10 mg/kg every 2 weeks starting day 15.  Study results showed that all patients suffered treatment-related toxicities; common grade ≥3 toxicities were hypertension (17.1%) , muscle weakness (17.1%) , lymphopenia (14.6%) , and hypophosphatemia (9.8%) .  Researchers then compared the data with results from previous clinical trials assessing the clinical benefit of bevacizumab monotherapy.  They concluded that tandutinib with bevacizumab was as effective but more toxic than bevacizumab monotherapy.  Which of the following best describes this type of study?


A) Preclinical study
B) Phase I clinical trial
C) Phase II clinical trial
D) Phase III clinical trial
E) Phase IV clinical trial

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