Know Cancer

forgot password

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

18 Years
Open (Enrolling)
Hepatocellular Cancer

Thank you

Trial Information

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

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

- 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

- 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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

4 years

Safety Issue:



Australia:SWAHS Human Research Ethics Committee

Study ID:




Start Date:

February 2010

Completion Date:

February 2014

Related Keywords:

  • Hepatocellular Cancer
  • Patients with advanced hepatocellular cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular