CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
Sorafenib Standard Dosing Regimen +1 moredrug
Likely dose
Sorafenib Standard Dosing Regimen 400 mgfrom 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.

Search/NCT01203787
NCT01203787Phase 4Completed
CompareCT.gov

Multicenter, Randomized Pilot Study of the Effect of Sorafenib Dosing Schedule on Tolerability and Drug Delivery

University of Florida·interventional·Posted Sep 16, 2010·Updated Mar 5, 2015

In Brief

A Phase 4 clinical trial evaluating Sorafenib Standard Dosing Regimen and Sorafenib Ramp-Up Regimen for Hepatocellular Carcinoma. Completed, enrolled 120 participants across 9 sites.

Detailed Summary

Open-label study to evaluate the safety and tolerability of Sorafenib dose ramp-up (starting at a lower dose and then gradually increasing the dose) versus standard Sorafenib dosing in subjects with unresectable and/or metastatic hepatocellular carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2010
Enrollment StartDec 1, 2010
Primary CompletionJan 1, 2014
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.8 years ago

Interventions

Sorafenib Standard Dosing Regimendrug

Sorafenib 400 mg twice daily until wk 24 or end of treatment

Sorafenib Ramp-Up Regimendrug

200 mg daily, Day 0-Day 13 200 mg twice daily, Day 14-Day 20 600 mg daily, Day 21-Day 27 400 mg twice daily, Day 28 until end of treatment400 mg twice daily