A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients With Advanced/Metastatic Hepatocellular Carcinoma
A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability,
Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients with
Advanced/Metastatic Hepatocellular Carcinoma.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Investigation of the safety and tolerability of AZD9150 when given intravenously to patients with hepatocellular carcinoma and determine a recommended phase II dose and schedule (RP2D) by evaluating dose limiting toxicities occurred during cycle 1.
For routine safety monitoring, visit scheduled on Screening, Cycle1Day1, 3, 5, 8, 15 and 22, Day1, 8, 15 and 22 of every Cycle until study discontinuation and 28-day follow up,assessed up to 12 months.
Assessed up to12 months
Becker Hewes, MD
South Korea: Korea Food and Drug Administration (KFDA)