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Trial of Sorafenib in Hepatocellular Cancer (HCC) Transplant Patients

NCT00997022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-08-10

No results posted yet for this study

Summary

This Phase I study of sorafenib in high risk hepatocellular cancer patients after liver transplantation will study 24 subjects for about 5 years. Each subject will receive sorafenib for 6 months. Safety and effectiveness on the post transplant, high risk HCC patients will be studied.

Conditions

  • Hepatocellular Cancer

Interventions

DRUG

Sorafenib

Dose escalation: Dose level 1: 200mg of sorafenib daily Dose level 2: 200mg of sorafenib BID (twice daily) Dose level 3: 200mg QAM (taken every morning) and 400mg QPM (taken every evening) Dose level 4: 400mg BID (twice daily)

Sponsors & Collaborators

Principal Investigators

  • Abby Siegel, MD, MS · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00997022 on ClinicalTrials.gov