Drug Monitoring of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

NCT01078311 | Unknown DMC

• 1 other identifier: MWWH009
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Patients with advanced hepatocellular cancer

Outcome Measures

Primary Outcomes (1)

• To demonstrate the correlation of trough sorafenib level with overall survival in advanced hepatocellular carcinoma

  4 years

Secondary Outcomes (4)

• To correlate trough sorafenib level with progression free survival

  4 years

• To correlate trough sorafenib level with response (disease-control vs progressive disease) by RECIST criteria

  4 years

• To correlate trough sorafenib level with alpha fetoprotein (AFP) response

  4 years

• To correlate trough sorafenib level with side effects (rash and hypertension)

  4 years

Study Arms (1)

HCC patients on Sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with advanced HCC who are to commence Sorafenib

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• South West Sydney Local Health District: lead

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Mark Wong, MBBS, FRACP

CONTACT

61298455200; Mark.Wong@swahs.health.nsw.gov.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2014
• Last Updated: March 2, 2010

Record last verified: 2010-02

Locations

AU (1)