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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Phase 2 Study of Measurement of Trough Levels of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Secondary ID [1] 0 0
MWWH009
Universal Trial Number (UTN)
Trial acronym
DOSE-HEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
HCC patients on Sorafenib -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To demonstrate the correlation of trough sorafenib level with overall survival in advanced hepatocellular carcinoma
Timepoint [1] 0 0
4 years
Secondary outcome [1] 0 0
To correlate trough sorafenib level with progression free survival
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
To correlate trough sorafenib level with response (disease-control vs progressive disease) by RECIST criteria
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
To correlate trough sorafenib level with alpha fetoprotein (AFP) response
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
To correlate trough sorafenib level with side effects (rash and hypertension)
Timepoint [4] 0 0
4 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2014
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01078311
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mark Wong, MBBS, FRACP
Address 0 0
Country 0 0
Phone 0 0
61298455200
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01078311