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NCT01203787 · ClinicalTrials.gov registry record · Phase 4

Sorafenib Dose Ramp-Up in Hepatocellular Carcinoma (HCC)

A Phase 4 study of Hepatocellular Carcinoma, sponsored by University of Florida.

Completed
Registry status
Phase 4
Development phase
120
Enrollment target
9
Study locations

NCT01203787: Completed Phase 4 study of Hepatocellular Carcinoma, sponsored by University of Florida.

NCT01203787 is a Phase 4 study of Hepatocellular Carcinoma that has completed, run by University of Florida. The registered enrollment target is 120 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (53% lower). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01203787, a Phase 4 study of Hepatocellular Carcinoma, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 4
Development phase
120 participants
Enrollment target
9
Study locations

Study 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.

Primary Outcome

This outcome measure table shows the median cumulative dose delivered to the subjects randomized to the standard dosing regimen (N=63) and ramp-up regimen (N=57) at 4 months of treatment.

Conditions Studied

Interventions

  • DRUG Sorafenib Standard Dosing Regimen
  • DRUG Sorafenib Ramp-Up Regimen

Study Locations (9)

Florida

  • University of Florida Hepatology - Gainesville
  • Mayo Clinic - Jacksonville
  • Florida Hospital Transplant Center - Orlando
  • Tampa General Hospital - Tampa

Texas

  • University of Texas Health Science Center Houston - Houston
  • Brooke Army Medical Center - San Antonio

Illinois

  • Loyola University Medical Center - Maywood

Michigan

  • Henry Ford Health System - Detroit

Pennsylvania

  • Drexel University College of Medicine - Philadelphia

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2010-12
Est. Completion 2014-03
Phase Phase 4
University of Florida

1,106 total trials

What the finished NCT01203787 record still lists

NCT01203787 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (53% lower).

The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Sorafenib Standard Dosing Regimen is the first listed.

NCT01203787 lists 9 locations in 5 states (Florida, Texas, Illinois).

Frequently Asked Questions

What is clinical trial NCT01203787 about?

NCT01203787 is a clinical study titled "Sorafenib Dose Ramp-Up in Hepatocellular Carcinoma (HCC)". 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.

What is the current status of trial NCT01203787?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2010-12. Estimated completion is 2014-03.

What conditions does trial NCT01203787 study?

This clinical trial studies the following conditions: Hepatocellular Carcinoma.

What interventions are being tested in trial NCT01203787?

The interventions under investigation include: Sorafenib Standard Dosing Regimen (DRUG), Sorafenib Ramp-Up Regimen (DRUG).

Who is sponsoring clinical trial NCT01203787?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01203787 being conducted?

This trial has 9 study locations across Florida, Illinois, Michigan, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Hepatocellular Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01203787's enrollment target sits among peer trials

120 52nd of 145 higher than 93 of 145 other Hepatocellular Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01203787, the US trial registry maintained by the National Library of Medicine. NCT01203787 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.