Hepatocellular Carcinoma Clinical Trial
Official title:
A Multicentre, Open Label, Phase I Trial in Japan of the MEK Inhibitor Pimasertib Given Orally to Subjects With Solid Tumors as Monotherapy
This is a two-part trial. "Solid tumor" in this protocol means solid tumor excluding
hepatocellular carcinoma (HCC).
Part 1: Dose Escalation Phase in subjects with solid tumor (Cohort A) and HCC (Cohort B).
The dose will be increased from 45 mg twice a day (BID) with 3+3 cohort method up to the
recommended phase 2 dose (RP2D) of pimasertib established as single agent in the global
studies for each arm independently.
Part 2: The Maximum Tolerated Dose (MTD) defined in Part 1 will be confirmed in more
subjects in Cohort A (N=18) and Cohort B (N=6) separately.
Following the recommendation by the Safety Monitoring Committee, Cohort B was discontinued
due to hepatocellular carcinoma (HCC) and there will be no further enrollment of subjects to
this cohort. This decision is based upon review of safety and efficacy information.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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