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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01078311
Registration number
NCT01078311
Ethics application status
Date submitted
1/03/2010
Date registered
2/03/2010
Date last updated
2/03/2010
Titles & IDs
Public title
Drug Monitoring of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
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Scientific title
Phase 2 Study of Measurement of Trough Levels of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
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Secondary ID [1]
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MWWH009
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Universal Trial Number (UTN)
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Trial acronym
DOSE-HEP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Cancer
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Condition category
Condition code
Cancer
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Liver
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
HCC patients on Sorafenib -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To demonstrate the correlation of trough sorafenib level with overall survival in advanced hepatocellular carcinoma
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Assessment method [1]
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Timepoint [1]
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4 years
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Secondary outcome [1]
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To correlate trough sorafenib level with progression free survival
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Assessment method [1]
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Timepoint [1]
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4 years
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Secondary outcome [2]
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To correlate trough sorafenib level with response (disease-control vs progressive disease) by RECIST criteria
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Assessment method [2]
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Timepoint [2]
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4 years
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Secondary outcome [3]
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To correlate trough sorafenib level with alpha fetoprotein (AFP) response
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Assessment method [3]
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Timepoint [3]
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4 years
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Secondary outcome [4]
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To correlate trough sorafenib level with side effects (rash and hypertension)
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Assessment method [4]
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Timepoint [4]
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4 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/02/2014
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Funding & Sponsors
Primary sponsor type
Other
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Name
South West Sydney Local Health District
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01078311
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Mark Wong, MBBS, FRACP
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Address
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Country
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Phone
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61298455200
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01078311
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