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Trial registered on ANZCTR


Registration number
ACTRN12605000643673
Ethics application status
Approved
Date submitted
14/10/2005
Date registered
14/10/2005
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Date results information initially provided
5/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase III randomised study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer
Scientific title
A Phase III randomised study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer, to compare the overall survival of patients.
Secondary ID [1] 193 0
Bayer Australia Ltd: 11213 Raf Kinase RCC Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable and /or metastatic renal cell cancer. 774 0
Condition category
Condition code
Cancer 849 849 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be randomised to receive either BAY 43-9006 400 mg (2x200 mg tablets) or matching placebo (2 tablets) administered orally twice daily in combination with Best Supportive Care.
The Treatment Period for the study drug will include dosing twice daily in an uninterrupted schedule, the treatment period will be divided into 6 week cycles for the first 24 weeks of treatment. Cycles beyond 24 weeks of treatment will be 8 weeks in duration. Treatment will continue until unacceptable toxicity thought to be related to the study drug and which requires discontinuation of drug is found or consent is withdrawn.
Once a patient progresses, the patient may be unblinded and given the opportunity to continue on BAY 43-9006.
Intervention code [1] 716 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1090 0
The primary objective is to compare the overall survival between patients treated with BAY 43-9006 versus placebo.
Timepoint [1] 1090 0
6 months
Secondary outcome [1] 2023 0
To evaluate Progression-free Survival (PFS).
Timepoint [1] 2023 0
6 months
Secondary outcome [2] 2024 0
To evaluate the best overall response rate (proportion of patients with confirmed partial and complete responses).
Timepoint [2] 2024 0
6 months
Secondary outcome [3] 2025 0
To assess changes in the patients health-related quality of life (HRQOL) and symptom response.
Timepoint [3] 2025 0
6 months

Eligibility
Key inclusion criteria
Patients who have a life expectancy of at least 12 weeksPatients, who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented. Patients must have had only one prior systemic therapy for advanced disease on which the patient progressed. Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumours (RECIST) Patients with Intermediate or low risk per the Motzer score.Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1. Adequate hepatic function.Amylase and lipase <1.5 x the upper limit of normal.Serum creatinine <2.0 x the upper limit of normal. PT or INR and PTT <1.5 x upper limit of normal.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumours [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry). Patients who completed their prior systemic treatment regimen less than 30 days or greater than 8 months prior to randomisation.Cardiac arrhythmias, symptomatic coronary artery disease or ischaemia or congestive heart failure. Active clinically serious bacterial or fungal infections.Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or CKnown history or presence of metastatic brain or meningeal tumours.Patients with seizure disorder requiring medication.History of organ allograftSubstance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results.Patients with "high" risk per Motzer criteria.Known or suspected allergy to the investigational agent or any agent given in association with this trial.Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study.Pregnant 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)
The randomisation number will be assigned based on information obtained from the IVRS system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation list.
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)

Funding & Sponsors
Funding source category [1] 936 0
Commercial sector/Industry
Name [1] 936 0
Bayer Australia Ltd
Address [1] 936 0
875 Pacific Highway Pymble NSW 2073
Country [1] 936 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] 794 0
None
Name [1] 794 0
None
Address [1] 794 0
Country [1] 794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305283 0
Austin Health Research Ethics Unit
Ethics committee address [1] 305283 0
Henry Buck Building
Austin Health
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 305283 0
Australia
Date submitted for ethics approval [1] 305283 0
Approval date [1] 305283 0
24/10/2003
Ethics approval number [1] 305283 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Antoun S, Birdsell L, Sawyer MB, Venner P, Escudier B, Baracos VE. Association of skeletal muscle wasting with treatment with sorafenib in patients with advanced renal cell carcinoma: results from a placebo-controlled study. J Clin Oncol. 2010 Feb 20;28(6):1054-60. doi: 10.1200/JCO.2009.24.9730. Epub 2010 Jan 19.

Bellmunt J, Eisen T, Fishman M, Quinn D. Experience with sorafenib and adverse event management. Crit Rev Oncol Hematol. 2011 Apr;78(1):24-32. doi: 10.1016/j.critrevonc.2010.03.006. Epub 2010 Apr 18. Review.

Massard C, Zonierek J, Gross-Goupil M, Fizazi K, Szczylik C, Escudier B. Incidence of brain metastases in renal cell carcinoma treated with sorafenib. Ann Oncol. 2010 May;21(5):1027-31. doi: 10.1093/annonc/mdp411. Epub 2009 Oct 22.

Negrier S, Jäger E, Porta C, McDermott D, Moore M, Bellmunt J, Anderson S, Cihon F, Lewis J, Escudier B, Bukowski R. Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET. Med Oncol. 2010 Sep;27(3):899-906. doi: 10.1007/s12032-009-9303-z. Epub 2009 Sep 12.

Peña C, Lathia C, Shan M, Escudier B, Bukowski RM. Biomarkers predicting outcome in patients with advanced renal cell carcinoma: Results from sorafenib phase III Treatment Approaches in Renal Cancer Global Evaluation Trial. Clin Cancer Res. 2010 Oct 1;16(19):4853-63. doi: 10.1158/1078-0432.CCR-09-3343. Epub 2010 Jul 22.

Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM. Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009 Jul 10;27(20):3312-8. doi: 10.1200/JCO.2008.19.5511. Epub 2009 May 18.

Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R, Cihon F, Anderson S, Shah S, Bukowski R, Escudier B; TARGET Study Group. Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial. J Natl Cancer Inst. 2008 Oct 15;100(20):1454-63. doi: 10.1093/jnci/djn319. Epub 2008 Oct 7.

Bukowski R, Cella D, Gondek K, Escudier B; Sorafenib TARGETs Clinical Trial Group. Effects of sorafenib on symptoms and quality of life: results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol. 2007 Jun;30(3):220-7.

Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203.

Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, Liang C, Booth B, Chidambaram N, Morse D, Sridhara R, Garvey P, Justice R, Pazdur R. Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res. 2006 Dec 15;12(24):7271-8. Review.

Lamuraglia M, Escudier B, Chami L, Schwartz B, Leclère J, Roche A, Lassau N. To predict progression-free survival and overall survival in metastatic renal cancer treated with sorafenib: pilot study using dynamic contrast-enhanced Doppler ultrasound. Eur J Cancer. 2006 Oct;42(15):2472-9. Epub 2006 Sep 11. Erratum in: Eur J Cancer. 2007 May;43(8):1336.
Public notes

Contacts
Principal investigator
Name 35828 0
Address 35828 0
Country 35828 0
Phone 35828 0
Fax 35828 0
Email 35828 0
Contact person for public queries
Name 9905 0
Clinical Research Manager
Address 9905 0
Bayer Australia Limited
PO Box 903
Pymble NSW 2073
Country 9905 0
Australia
Phone 9905 0
+61 2 93916140
Fax 9905 0
Email 9905 0
@bayerhealthcare.com
Contact person for scientific queries
Name 833 0
Medical Services Manager
Address 833 0
Bayer Australia Limited
PO Box 903
Pymble NSW 2073
Country 833 0
Australia
Phone 833 0
+61 2 93916147
Fax 833 0
Email 833 0
@bayerhealthcare.com

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