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Randomized Phase I/II of RAD001 in Advanced Hepatocellular Carcinoma (HCC)

NCT00390195 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2009-07-02

No results posted yet for this study

Summary

The mTOR has been examined in hepatocellular carcinomas as well. This pathway is up-regulated in a proportion of hepatocellular carcinoma (HCC) and that rapamycin inhibits cell proliferation and blocks S6K phosphorylation. Inhibition of mTOR had been shown to suppress substantially the liver tumor growth. Nevertheless, inhibition of mTOR was demonstrated to have a clinical response in some cancer types. These reports imply that inhibition of mTOR could be a promising therapeutic strategy in the treatment of HCC. Therefore, we hypothesize that RAD001, a rapamycin analog, can inhibit the mTOR, and subsequently suppress the liver tumor in the treatment of HCC patients.

This study is aimed to investigate the safety, efficacy, pharmacokinetics, pharmacogenetics and feasibility of RAD001 in advanced HCC patients. This study will be a randomized phase I study with dose escalation and subsequently a phase II study of intent to treat, as well as pharmacokinetic, pharmacogenetic and surrogate marker study of RAD001.

Conditions

Interventions

DRUG

RAD001 (everolimus)

Arm 1: 2.5, 5, 7.5 or 10 mg of RAD001 daily

DRUG

RAD001 (everolimus)

Arm 2: 20, 30, 50 or 70 mg of RAD001 daily

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Li-Tzong Chen, M.D., Ph.D. · National Institute of Cancer Research, National Health Research Institutes, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-06-30
Completion
2011-06-30

Countries

  • Taiwan

Study Locations

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Entities

Diseases
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 NCT00390195 on ClinicalTrials.gov