Drug Monitoring of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

NCT ID: NCT01078311

Last Updated: 2010-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-02-28

Brief Summary

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.

Conditions

Hepatocellular Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HCC patients on Sorafenib

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South West Sydney Local Health District

OTHER

Sponsor Role: lead

Responsible Party

Westmead Medical Oncology

Locations

Westmead Hospital

Westmead, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Mark Wong, MBBS, FRACP

Role: CONTACT

Mark.Wong@swahs.health.nsw.gov.au

61298455200 ext. 55200

Other Identifiers

MWWH009

Identifier Type: -

Identifier Source: org_study_id