Drug Monitoring of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (DOSE-HEP)
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ClinicalTrials.gov Identifier: NCT01078311 |
Recruitment Status
: Unknown
Verified February 2010 by South West Sydney Local Health District.
Recruitment status was: Recruiting
First Posted
: March 2, 2010
Last Update Posted
: March 2, 2010
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Condition or disease |
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Hepatocellular Cancer |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Phase 2 Study of Measurement of Trough Levels of Sorafenib in Patients With Advanced Hepatocellular Carcinoma |
Study Start Date : | February 2010 |
Estimated Primary Completion Date : | February 2012 |
Estimated Study Completion Date : | February 2014 |

Group/Cohort |
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HCC patients on Sorafenib |
- To demonstrate the correlation of trough sorafenib level with overall survival in advanced hepatocellular carcinoma [ Time Frame: 4 years ]
- To correlate trough sorafenib level with progression free survival [ Time Frame: 4 years ]
- To correlate trough sorafenib level with response (disease-control vs progressive disease) by RECIST criteria [ Time Frame: 4 years ]
- To correlate trough sorafenib level with alpha fetoprotein (AFP) response [ Time Frame: 4 years ]
- To correlate trough sorafenib level with side effects (rash and hypertension) [ Time Frame: 4 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078311
Contact: Mark Wong, MBBS, FRACP | 61298455200 ext 55200 | Mark.Wong@swahs.health.nsw.gov.au |
Australia, New South Wales | |
Westmead Hospital | Recruiting |
Westmead, New South Wales, Australia, 2145 |
Responsible Party: | Mark Wong, Westmead Medical Oncology |
ClinicalTrials.gov Identifier: | NCT01078311 History of Changes |
Other Study ID Numbers: |
MWWH009 |
First Posted: | March 2, 2010 Key Record Dates |
Last Update Posted: | March 2, 2010 |
Last Verified: | February 2010 |
Keywords provided by South West Sydney Local Health District:
Patients with advanced hepatocellular cancer |
Additional relevant MeSH terms:
Carcinoma, Hepatocellular Liver Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Sorafenib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |