An Open Label, Dose Escalation Phase I Study to Evaluate the Safety and Tolerability of Continuous Twice-daily Oral Treatment of Nintedanib in Japanese Patients With Hepatocellular Carcinoma.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of maximum tolerated dose (MTD) of nintedanib
up to 1 month
Yes
Boehringer Ingelheim
Study Chair
Boehringer Ingelheim Pharmaceuticals
Japan: Ministry of Health, Labor and Welfare
1199.120
NCT01594125
May 2012
August 2014
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