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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00631371




Registration number
NCT00631371
Ethics application status
Date submitted
28/02/2008
Date registered
7/03/2008
Date last updated
27/04/2016

Titles & IDs
Public title
Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
Scientific title
Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
Secondary ID [1] 0 0
B1771006
Secondary ID [2] 0 0
3066K1-3311
Universal Trial Number (UTN)
Trial acronym
INTORACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Temsirolimus
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Interferon-Alfa 9MU

Experimental: 1 - Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly

Active Comparator: 2 - Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW


Treatment: Drugs: Bevacizumab
Bevacizumab 10 mg/kg intravenous (IV) q8wks

Treatment: Drugs: Temsirolimus
Temsirolimus 25 mg IV weekly

Treatment: Drugs: Bevacizumab
Bevacizumab 10 mg/kg intravenous (IV) q8wks

Treatment: Drugs: Interferon-Alfa 9MU
Interferon-Alfa 9MU SC TIW

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

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS): Independent-Assessment - PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Timepoint [1] 0 0
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS): Investigator-Assessment - PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Timepoint [1] 0 0
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Secondary outcome [2] 0 0
Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment - Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Timepoint [2] 0 0
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Secondary outcome [3] 0 0
Overall Survival (OS) - OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Timepoint [3] 0 0
Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Eligibility
Key inclusion criteria
- Histologically and/or cytologically confirmed to have advanced renal cell carcinoma
(RCC)

- Majority component of conventional clear-cell type is mandatory

- At least 1 measurable lesion (per RECIST)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior systemic treatment for RCC

- Evidence of current or prior central nervous system (CNS) metastases

- Cardiovascular disease

- Pregnant or nursing women

- Additional criteria applies

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
Open (masking not used)
Who is / are masked / blinded?



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)
QLD,SA
Recruitment hospital [1] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [4] 0 0
Cancer Care SA - Kurralta Park
Recruitment hospital [5] 0 0
Mater Private Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
QLD 4101 - South Brisbane
Recruitment outside Australia
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United States of America
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Arkansas
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California
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Mississippi
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Oklahoma
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Tennessee
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Washington
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Argentina
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Santa Fé
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Argentina
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Tucuman
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Argentina
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Santa Fe
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Belgium
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Antwerpen
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Mont-Godinne
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GO
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Rio Grande do Sul
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Ontario
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Chile
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Santiago
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Colombia
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Risaralda
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Ceska republika
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Czech Republic
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Brno
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Czech Republic
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Olomouc
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Usti nad Labem
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Nimes
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Suresnes
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Hannover
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Chai Wan
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Budapest
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Gyor
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ROC
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Tao Yuan
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Ukraine
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Kiev
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Kiyv
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Ukraine
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Medychna vul., Ivano-Frankivsk
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United Kingdom
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Hampshire
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Manchester
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North Yorkshire
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary objective: Comparison of independently assessed progression free survival (PFS) in
subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab +
Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response
rate (independently assessed), and overall survival.
Trial website
https://clinicaltrials.gov/show/NCT00631371
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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