Drug Monitoring of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (DOSE-HEP)

March 1, 2010 updated by: South West Sydney Local Health District

Phase 2 Study of Measurement of Trough Levels of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Sorafenib improves overall survival and progression free survival in advanced hepatocellular carcinoma. Wide interindividual pharmacokinetic variability was observed. Data from early phase trials in solid tumours showed trough sorafenib levels were associated with incidence of skin rash and hypertension. Rash, hypertension and higher trough levels were moderately predictive of progression free survival.The trough level of sorafenib may be predictive of survival and response in patients treated with sorafenib for advanced hepatocellular carcinoma.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with advanced HCC who are to commence Sorafenib

Description

Inclusion Criteria:

  • ECOG ≤ 2
  • Histologically or cytologically diagnosed hepatocellular carcinoma, or diagnosis on at least one cross-sectional imaging with the characteristic appearance of HCC (i.e. liver lesion with arterial enhancement and portal venous washout)
  • Decision to treat with single agent sorafenib at 400mg bid (dose reductions or interruptions are permitted if side effects occur during treatment)
  • No prior systemic chemotherapy or targeted therapy
  • Child-Pugh liver function class A or B
  • At least one untreated target lesion that can be measured in one dimension according to RECIST
  • Adequate organ functions

Exclusion Criteria:

  • Prior systemic chemotherapy or molecularly targeted therapy
  • Concurrent active malignancy
  • Concomitant strong CYP3A4 induced or inhibitor at a therapeutic dose (see section 6.4.1)
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  • Hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical therapy)
  • History of, or known brain metastases (skull metastases allowed), carcinomatous meningitis, or leptomenigeal disease
  • Major surgery (e.g. open abdominal therapy, pelvic, thoracic, orthopaedic or neurosurgery) within 4 weeks of the date of first dose
  • Local-regional treatment (i.e. percutaneous and trans-arterial procedures) within 4 weeks. Restaging CT or MRI scan must be repeated at least 4 weeks after local-regional treatment and within 3 weeks before the date of first dose
  • For patients treated with Yttrium (90Y) radiotherapy, a washout period of 2 months is required.
  • Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol
  • Pregnancy or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HCC patients on Sorafenib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate the correlation of trough sorafenib level with overall survival in advanced hepatocellular carcinoma
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To correlate trough sorafenib level with progression free survival
Time Frame: 4 years
4 years
To correlate trough sorafenib level with response (disease-control vs progressive disease) by RECIST criteria
Time Frame: 4 years
4 years
To correlate trough sorafenib level with alpha fetoprotein (AFP) response
Time Frame: 4 years
4 years
To correlate trough sorafenib level with side effects (rash and hypertension)
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South West Sydney Local Health District

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

March 1, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MWWH009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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