A sponsor has successfully completed a Phase I trial for a new oncology drug, establishing its initial safety profile and identifying a maximum tolerated dose in healthy volunteers. What is the primary objective of the subsequent Phase II clinical trial?
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A
To confirm the drug's efficacy and safety in a large, diverse patient population to support a New Drug Application (NDA).
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B
To gather post-marketing data on the drug's long-term risks, benefits, and optimal use in the general patient population.
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C
To evaluate the drug's effectiveness for a specific cancer type in a well-defined patient group and to further assess its short-term safety and side effects.
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D
To determine the drug's metabolism, pharmacokinetic properties, and major toxicities for the first time in human subjects.