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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/NCT00073307




Registration number
NCT00073307
Ethics application status
Date submitted
19/11/2003
Date registered
21/11/2003
Date last updated
6/02/2014

Titles & IDs
Public title
Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
Scientific title
A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
Secondary ID [1] 0 0
11213
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sorafenib (Nexavar, BAY43-9006)
Treatment: Drugs - Placebo

Experimental: Sorafenib (Nexavar, BAY43-9006) - Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.

Placebo Comparator: Placebo - Placebo tablets matching in appearance were to be orally administered twice a day.


Treatment: Drugs: Sorafenib (Nexavar, BAY43-9006)
Multi Kinase Inhibitor

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
Timepoint [1] 0 0
From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Primary outcome [2] 0 0
Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population
Timepoint [2] 0 0
From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Secondary outcome [1] 0 0
Final Progression-Free Survival (PFS) - Independent Radiological Review
Timepoint [1] 0 0
From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
Secondary outcome [2] 0 0
Best Overall Response - Independent Radiological Review
Timepoint [2] 0 0
From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
Secondary outcome [3] 0 0
Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment
Timepoint [3] 0 0
From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
Secondary outcome [4] 0 0
Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment
Timepoint [4] 0 0
From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.

Eligibility
Key inclusion criteria
- Patients with unresectable and/or metastatic, measurable renal cell carcinoma
histologically or cytologically documented

- Patients must have had one prior systemic therapy for advanced disease, which was
completed at least 30 days but no longer than 8 months prior to randomization

- Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI
according to Response Evaluation Criteria in Solid Tumors (RECIST)

- Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of
0 or 1

- Patients who have adequate coagulation, liver and kidney functions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell
tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma,
medullary carcinoma, or chromophobe oncocytic tumors

- Previous malignancy (except for cervical carcinoma in situ, adequately treated basal
cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated
> 2 years prior to entry

- Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or
ischemia or congestive heart failure

- Patients with a history of human immunodeficiency virus (HIV) infection or chronic
hepatitis B or C

- Patients with a history or presence of metastatic brain or meningeal tumors

- Patients with seizure disorder requiring medication (such as anti-epileptics)

- History of organ allograft or bone marrow transplant of stem cell rescue

- Patients who are pregnant or breast-feeding Women of childbearing potential must have
a negative pregnancy test prior to drug administration. Both men and women enrolled in
this trial must use adequate birth control

- Patients who have three or more of the following:

- ECOG performance status greater than or equal to 2,

- Abnormally high lactate dehydrogenase,

- Abnormally high serum hemoglobin,

- Abnormally high corrected serum calcium,

- Absence of prior nephrectomy

- Excluded therapies and medications, previous and concomitant:

- Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except
biphosphonates

- Significant surgery with 4 weeks of start of study

- Investigational drug therapy during or within 30 days

- Concomitant treatment with rifampin or St. John's Wort

- Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors

- Prior use of Bevacizumab, and all other drugs (investigational or licensed) that
target VEGF/VEGF receptors

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
903
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Liverpool
Recruitment hospital [4] 0 0
- Westmead
Recruitment hospital [5] 0 0
- Heidelberg
Recruitment hospital [6] 0 0
- Wodonga
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
0390 - Wodonga
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Wisconsin
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Argentina
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Santa Fe
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Mendoza
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Bruxelles - Brussel
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Parana
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Roma
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Lviv
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Stratchclyde
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Surrey
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Tyne and Wear
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West Midlands
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Amgen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate safety, efficacy (including quality of life), and
pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with
unresectable and/or metastatic renal cell cancer, who have received one prior systemic
regimen for advanced disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00073307
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries