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Trial registered on ANZCTR


Registration number
ACTRN12606000140550
Ethics application status
Approved
Date submitted
11/04/2006
Date registered
24/04/2006
Date last updated
12/02/2020
Date data sharing statement initially provided
12/02/2020
Date results information initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open-Label, Non-Comparative Expanded Access Study of the Raf-Kinase Inhibitor Sorafenib as a Subsequent to First-Line Therapy in Patients with Advanced Renal Cell Carcinoma
Scientific title
An Open-Label, Non-Comparative Expanded Access Study of the Raf-Kinase Inhibitor Sorafenib (Bay 43-9006) as a Subsequent to First-Line Therapy in Patients with Advanced Renal Cell Carcinoma, Assessing Safety and Efficacy.
Secondary ID [1] 300528 0
BAY 43-9006 / 12575
Universal Trial Number (UTN)
Trial acronym
AUS1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced renal cell carcinoma 1109 0
Condition category
Condition code
Cancer 1189 1189 0 0
Renal Cell Carcinoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of this study is to make BAY 43-9006 (sorafenib) available for patients with advanced renal cell carcinoma (RCC), who failed prior systemic therapy for advanced disease (i. e., require second-line treatment), and who do not have access to or are not eligible for other clinical trials with BAY 43-9006. In addition, safety data and limited efficacy data will be collected.

Patients will be treated with 400 mg oral BAY 43-9006 twice a day. Patients in this protocol may continue to be treated with BAY 43-9006 as a single agent until any of the following criteria for drug or protocol discontinuation is reached:

a. Progression of disease.
b. The patient is unlikely to benefit from further treatment with BAY 43-9006 as judged by the Investigator.
c. Intolerable toxicity of the drug.
d. Withdrawal of consent for any reason.

It is the intention to continue to recruit patients into the protocol until BAY 43-9006 is registered within Australia by the TGA. Patients, who are enrolled in this study at the time point, when BAY 43-9006 is approved by the Therapeutic Goods Administration (TGA), will continue to be treated in this study.
Intervention code [1] 979 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1603 0
The primary outcome will be progression of disease
Timepoint [1] 1603 0
Assessed at monthly visits by appropriate radiological and other procedures according to the local standard of care.
Secondary outcome [1] 2902 0
nil
Timepoint [1] 2902 0
nil

Eligibility
Key inclusion criteria
The patient must provide written informed consent prior to receiving BAY 43-9006.The patient must have advanced Renal Cell Carcinoma.The patient must have failed at least one prior systemic established therapy for advanced RCC, or must have been unable to tolerate systemic therapy for advanced RCC, or is deemed by the Investigator to be unsuited for systemic therapy for advanced RCC.A patient, who has received prior systemic and local therapies, must have completely recovered from acute toxicity, if any, prior to study entry.The patient must be, in the Investigator’s opinion, reasonably likely to benefit from treatment with BAY 43-9006 as a single agent.The patient must have an Eastern Cooperative Oncology Group performance status of 0-2.The patient will not require other systemic anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies) or hormonal therapy while taking BAY 43-9006. Treatment with bisphosphonates is permitted.Both male and female patients must use adequate barrier birth control methods (oral contraceptives, injectable contraceptives, intrauterine devices, condoms, sterilization) during their participation in the protocol.For patients, who have had major surgery, the wound must be completely healed prior to receiving BAY 43-9006 treatment (4 weeks).
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are currently enrolled in or have previously participated in any other BAY 43-9006 trial and who received BAY 43-9006.Patients, who are eligible for or do have access to any other BAY 43-9006 clinical trial as to the knowledge of the Investigator.Patients who have a life expectancy of less than 2 months.Patients with uncontrolled metastatic brain or meningeal tumours. Patientswith prior brain or meningeal metastases that have been adequately treatedand who show no evidence of progression are eligible.Patients are excluded who require any of the following:a. Investigational drug therapy during the treatment with BAY 43-9006 or within 30 days prior to their first dose of BAY 43-9006.b. Concomitant Rifampicin.c. Concomitant St. John’s Wort (Hypericum perforatum).Warfarin is allowed; however, for patients receiving concomitant warfarin therapy close monitoring of Prothrombin Time should be performed.Women who are pregnant or breast-feeding. Patients with congestive heart failure greater than New York Heart Association (NYHA) functional class II (symptomatic during ordinary activity).Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE.Patients with active coronary artery disease or ischemia.Patients with Child-Pugh class C hepatic impairment.Patients with severe renal impairment or who require dialysis.Patients with active uncontrolled hypertension.Patients with recent or active bleeding diathesis.Patients with any medical condition which could jeopardize their safety while taking an investigational drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
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)
NSW,VIC
Recruitment outside Australia
Country [1] 300 0
New Zealand
State/province [1] 300 0

Funding & Sponsors
Funding source category [1] 1300 0
Commercial sector/Industry
Name [1] 1300 0
Bayer Australia Limited
Address [1] 1300 0
Pacific Highway
Pymble NSW 2073
Country [1] 1300 0
Australia
Primary sponsor type
Government body
Name
Austin Health
Address
Heidelberg
Studley Road
Victoria 3084
Country
Australia
Secondary sponsor category [1] 1148 0
Government body
Name [1] 1148 0
Auckland District Health Board
Address [1] 1148 0
Epsom
Auckland
Country [1] 1148 0
New Zealand
Secondary sponsor category [2] 2649 0
Government body
Name [2] 2649 0
Sydney South West Area Health
Address [2] 2649 0
Camperdown
NSW 2050
Country [2] 2649 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4879 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 4879 0
Heidelberg
Ethics committee country [1] 4879 0
Australia
Date submitted for ethics approval [1] 4879 0
08/02/2006
Approval date [1] 4879 0
04/05/2006
Ethics approval number [1] 4879 0
New ethics HREC. Please modify.
Ethics committee name [2] 4880 0
Northern X Regional Ethics Committee
Ethics committee address [2] 4880 0
Wellesley Street
Auckland
Ethics committee country [2] 4880 0
New Zealand
Date submitted for ethics approval [2] 4880 0
Approval date [2] 4880 0
25/01/2007
Ethics approval number [2] 4880 0
New ethics HREC. Please modify.

Summary
Brief summary
This is a non-randomised, open-label treatment protocol for patients with advanced renal cell carcinoma, who received previous systemic therapy for advanced disease, and who do not have access to or are not eligible for other clinical trials with sorafenib (BAY 43-9006). Safety data and limited efficacy data will be collected.
Trial website
Trial related presentations / publications
DOI: 10.1200/jco.2013.31.6_suppl.465 Journal of Clinical Oncology 31, no. 6_suppl (February 20, 2013) 465-465.
Public notes

Contacts
Principal investigator
Name 35407 0
Address 35407 0
Country 35407 0
Phone 35407 0
Fax 35407 0
Email 35407 0
Contact person for public queries
Name 10168 0
Associate Professor Ian Davis
Address 10168 0
Ludwig Oncology Unit
Austin Health
Level 6
Harold Strokes Building (HSB)
Studley Road
Heidelberg VIC 3084
Country 10168 0
Australia
Phone 10168 0
+61 3 94965763
Fax 10168 0
Email 10168 0
Ian.Davis@ludwig.edu.au
Contact person for scientific queries
Name 1096 0
Associate Professor Ian Davis
Address 1096 0
Ludwig Oncology Unit
Austin Health
Level 6
Harold Strokes Building (HSB)
Studley Road
Heidelberg VIC 3084
Country 1096 0
Australia
Phone 1096 0
+61 3 94965763
Fax 1096 0
Email 1096 0
Ian.Davis@ludwig.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
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