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Pilot Study Sorafenib as Bridge to Orthotopic Liver Transplantation (OLT)

NCT01337492 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2012-03-21

No results posted yet for this study

Summary

Patients with either histological confirmation or clinical diagnosis who are candidate for orthotopic liver transplant(OLT) will receive Sorafenib 400mg 2 x day (BID) as a neoadjuvant (bridging) treatment until transplant. If patient progresses or falls outside of the Milan criteria on sorafenib patient can be treated per physician's discretion using local therapy. Patient will be followed until 30 days after the orthotopic liver transplant (OLT).

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Nexavar

400 mg of Sorafenib

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Onyx Therapeutics, Inc.

    collaborator INDUSTRY

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Robert Pelley, MD · CCF Taussig Cancer Solid Tumor Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-05-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT01337492 on ClinicalTrials.gov