At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Nintedanib high dose +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating Nintedanib high dose, Nintedanib low dose, and 1 other intervention for Carcinoma, Hepatocellular. Completed, enrolled 30 participants across 5 sites.
Detailed Summary
The aim of the study is to investigate the safety, tolerability, efficacy and pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to curative surgery or loco regional therapy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2012
First PostedMay 2012
Primary CompletionNov 2014
Study CompletionJan 2015
TodayJul 2026
First PostedMay 8, 2012
Enrollment StartMay 1, 2012
Primary CompletionNov 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.2 years ago
Interventions
Nintedanib high dosedrug
twice daily oral dosing
Nintedanib low dosedrug
twice daily oral dosing
Nintedanib medium dosedrug
twice daily oral dosing
Nintedanib medium dosedrug
twice daily oral dosing
Nintedanib high dosedrug
twice daily oral dosing