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Study of Sorafenib With Combination of Thalidomide in Hepatocellular Carcinoma (HCC)

NCT00971126 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2016-05-04

No results posted yet for this study

Summary

The purpose of this phase I study is to determine the maximal tolerable dose (MTD) of thalidomide (THADO®) in combination with fixed dose of sorafenib (NEXAVAR®) for the treatment of advanced or metastatic HCC.

The Phase II purpose of this study is to determine the disease control rate (complete response + partial response + stable disease) for at least 4 months of sorafenib (NEXAVAR®) plus phase I determined MTD of thalidomide (THADO®) in patients with advanced or metastatic HCC.

Conditions

Interventions

DRUG

sorafenib (Nexavar®), thalidomide (Thado®)

Phase I Fixed dose of Sorafenib 800mg/day (400mg, p.o., bid); and Escalation dose of Thalidomide at dose Level I: 50 mg/day (50mg, p.o., qd); Level II: 100 mg/day (50mg, p.o., bid); Level III: 150 mg/day (100mg/50mg, p.o., bid); Level IV: 200 mg/day (100mg, p.o., bid). Phase II Fixed dose of Sorafenib 800mg/day (400mg, p.o., bid); and MTD of Thalidomide at phase I study.

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Chung Hu Chan, MD, PHD · National Health Research Institutes, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-01-31
Completion
2010-03-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT00971126 on ClinicalTrials.gov