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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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)
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
Sex
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
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
791
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Mississippi
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Oklahoma
Country [6] 0 0
United States of America
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Tennessee
Country [7] 0 0
United States of America
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Washington
Country [8] 0 0
Argentina
State/province [8] 0 0
Santa Fé
Country [9] 0 0
Argentina
State/province [9] 0 0
Tucuman
Country [10] 0 0
Argentina
State/province [10] 0 0
Santa Fe
Country [11] 0 0
Belgium
State/province [11] 0 0
Antwerpen
Country [12] 0 0
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
Country [15] 0 0
Brazil
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GO
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Brazil
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Rio Grande do Sul
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Brazil
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RJ
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Brazil
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RS
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Brazil
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Sao Paulo
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Brazil
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SP
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Region Metropolitana / Chile
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Chile
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Santiago
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Colombia
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Risaralda
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Czech Republic
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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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Czech Republic
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Usti nad Labem
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France
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Clermont-Ferrand
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France
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Hyères
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France
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Le Chesnay
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France
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Nimes
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France
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Poitiers Cedex
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France
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Rouen Cedex
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France
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Saint-Herblain-Nantes
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France
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Suresnes
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France
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Villejuif Cedex
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Germany
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Berlin
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Muenchen
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Hong Kong
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Chai Wan
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Gyor
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Hungary
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Nyiregyhaza
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Hungary
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Szeged
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Veszprem
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Gujarat
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Kerala
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Rajasthan
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India
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Tamil Nadu
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Trivandrum
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Italy
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Bari
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Chieti
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Modena
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Perugia
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Roma
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Terni
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Korea, Republic of
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Korea
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Korea, Republic of
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Netherlands
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Gdansk
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Lublin
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Poznan
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Warszawa
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Portugal
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Porto
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Russian Federation
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Kaluga region
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Russian Federation
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Leningradskaya oblast
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Nizhni Novgorod
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Russian Federation
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Pesochny, Saint-Petersburg
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Russian Federation
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Saint-Petersburg
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Serbia
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Belgrade
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Singapore
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Singapore
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Martin
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Skalica
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Zilina
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Cape Town
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Durban
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Pretoria
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Western Cape
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Parktown
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Port Elizabeth
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Barcelona
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Cantabria
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Madrid
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Spain
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Valencia
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Taiwan
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ROC
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Tapei
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Taiwan
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Taichung
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Taiwan
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Taipei TOC
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Taiwan
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Tao Yuan
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Ukraine
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Chenivtsi
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Chernovtsi
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Ukraine
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Donetsk
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Kiev
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Ukraine
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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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United Kingdom
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Manchester
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United Kingdom
State/province [114] 0 0
North Yorkshire
Country [115] 0 0
United Kingdom
State/province [115] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00631371