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Trial registered on ANZCTR


Registration number
ACTRN12605000644662
Ethics application status
Approved
Date submitted
14/10/2005
Date registered
14/10/2005
Date last updated
13/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase III randomized, placebo-controlled study of sorafenib in patients with advanced hepatocellular carcinoma
Scientific title
A Phase III randomized, placebo-controlled study of sorafenib in patients with advanced hepatocellular carcinoma to assess overall survival and time to progression.
Secondary ID [1] 194 0
Bayer Australia Ltd: Raf Kinase HCC 100554
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced hepatocellular carcinoma. 775 0
Condition category
Condition code
Cancer 850 850 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized, double blinded trial to evaluate the clinical benefit of sorafenib 400 mg bid versus placebo in patients with advanced HCC (Child-Pugh A only).
The overall treatment period will be divided into 6-week cycles.
Patient visits for safety and drug accountability will be conducted every 3 weeks. The Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) Questionnaire will also be completed every three weeks.
The FHSI-8 and FACT-Hep questionnaires are being completed as part of an assessment of efficacy endpoints. Tumor measurements will be conducted on the first day of each cycle.
After study drug treatment ends, patients will be contacted every 3 months to determine survival status and to request that they complete the FHSI-8.

Recruitment is expected to be achieved by April 2006.
Intervention code [1] 717 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1091 0
Overall survival (OS)
Timepoint [1] 1091 0
Will be measured from the date of randomization until the date of death due to any cause.
Primary outcome [2] 1092 0
Time to symptomatic progression
Timepoint [2] 1092 0
Will be measured from the date of first objective response to the date that progressive disease is first objectively documented or death (if death occurs earlier than progression).
Secondary outcome [1] 2026 0
Time to progression (TTP).
Timepoint [1] 2026 0
The time from randomization to disease progression (radiological only).
Secondary outcome [2] 2027 0
Overall disease control rate.
Timepoint [2] 2027 0
Disease control rate is defined as the proportion of patients who have a best response rating of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST that is maintained for at least 28 days from the first demonstration of that rating.
Secondary outcome [3] 2028 0
Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Total Score.
Timepoint [3] 2028 0
FACT-Hep response rate will be based on the proportion of subjects who achieve the 8-point minimally important difference for this instrument.

Eligibility
Key inclusion criteria
Patients who have a life expectancy of at least 12 weeks.Patients with advanced HCC. Patients with histologically or cytologically documented HCC. Patients must have at least one tumor lesion that can be accurately measured in at least one dimension and has not been previously treated with local therapy.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted.Renal failure requiring hemo- or peritoneal dialysis.History of cardiac disease.Active clinically serious infections.Known history of human immunodeficiency virus (HIV) infection. Known Central Nervous System tumors including metastatic brain disease. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.History of organ allograft.Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results.Known or suspected allergy to the investigational agent or any agent given in association with this trial.Patients unable to swallow oral medications.Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the studyPregnant or breast-feeding patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sorafenib and placebo tablets will be identical in appearance in order to preserve blinding. In order to maintain this blind, study medication (sorafenib or placebo) will be labeled with a unique Bottle/Medication number, which will be assigned to a patient by using the telephone Interactive Voice Response System (IVRS).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomization list will be prepared by Bayer, using a unicentric randomization scheme.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 242 0
Argentina
State/province [1] 242 0

Funding & Sponsors
Funding source category [1] 937 0
Commercial sector/Industry
Name [1] 937 0
Bayer Australia Ltd
Address [1] 937 0
875 Pacific Highway Pymble NSW 2073
Country [1] 937 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bayer Australia Ltd
Address
875 Pacific Highway Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 795 0
None
Name [1] 795 0
None
Address [1] 795 0
Country [1] 795 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36071 0
Address 36071 0
Country 36071 0
Phone 36071 0
Fax 36071 0
Email 36071 0
Contact person for public queries
Name 9906 0
Clinical Research Manager
Address 9906 0
Bayer Australia Limited
PO Box 903
Pymble NSW 2073
Country 9906 0
Australia
Phone 9906 0
+61 2 93916140
Fax 9906 0
Email 9906 0
@bayerhealthcare.com
Contact person for scientific queries
Name 834 0
Medical Services Manager
Address 834 0
Bayer Australia Limited
PO Box 903
Pymble NSW 2073
Country 834 0
Australia
Phone 834 0
+61 2 93916147
Fax 834 0
Email 834 0
@bayerhealthcare.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary