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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by South West Sydney Local Health District.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
South West Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT01078311
First received: March 1, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

March 1, 2010
March 1, 2010
February 2010
February 2012   (final data collection date for primary outcome measure)
To demonstrate the correlation of trough sorafenib level with overall survival in advanced hepatocellular carcinoma [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • To correlate trough sorafenib level with progression free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To correlate trough sorafenib level with response (disease-control vs progressive disease) by RECIST criteria [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To correlate trough sorafenib level with alpha fetoprotein (AFP) response [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To correlate trough sorafenib level with side effects (rash and hypertension) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Drug Monitoring of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients with advanced HCC who are to commence Sorafenib

Hepatocellular Cancer
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HCC patients on Sorafenib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
February 2014
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mark Wong, MBBS, FRACP 61298455200 ext 55200 Mark.Wong@swahs.health.nsw.gov.au
Australia
 
NCT01078311
MWWH009
Yes
Mark Wong, Westmead Medical Oncology
South West Sydney Local Health District
Not Provided
Not Provided
South West Sydney Local Health District
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP