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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
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 - Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
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 - PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.
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 - Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.
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 - Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL.
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 - Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.
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
Gender
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
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)
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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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Minnesota
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Missouri
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New York
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Ohio
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Oregon
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Wisconsin
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Argentina
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Santa Fe
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Argentina
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Capital Federal-Buenos Aires
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Argentina
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Mendoza
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Belgium
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Bruxelles - Brussel
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Brazil
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Parana
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Brazil
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Rio Grande do Sul
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Ontario
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Quebec
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Chile
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Bordeaux
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Marseille
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France
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Nantes
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France
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Paris Cedex 15
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France
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Strasbourg
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Toulouse
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Villejuif
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Germany
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Baden-Württemberg
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Bayern
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Germany
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Hessen
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Nordrhein-Westfalen
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Sachsen
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Pavia
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Roma
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Nijmegen
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Gauteng
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Spain
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Bilbao
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Barcelona
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Madrid
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Valencia
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Ukraine
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Donetsk
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Kharkiv
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Kiev
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Ukraine
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Lviv
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Ukraine
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Poltava
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United Kingdom
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Middlesex
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South Glamorgan
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United Kingdom
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Stratchclyde
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United Kingdom
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Surrey
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United Kingdom
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Tyne and Wear
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United Kingdom
State/province [94] 0 0
West Midlands
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United Kingdom
State/province [95] 0 0
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/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
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications