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Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects (INTORACT)

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bevacizumab
Temsirolimus
Bevacizumab
Interferon-Alfa 9MU
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring temsirolimus, renal cell carcinoma, kidney cancer, urogenital cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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

Sites / Locations

  • Hematology Oncology Services of Arkansas
  • South County Hematology/Oncology
  • Cancer Center Oncology Medical Group
  • UCLA Medical Center
  • UCLA
  • UCLA
  • North County Oncology Medical Clinic
  • Medical Oncology Associates - SD
  • Sharp Memorial Hospital Investigational Pharmacy
  • Sharp Rees-Stealy
  • California Pacific Medical Center
  • Pacific Hematology/Oncology Associates
  • San Francisco Oncology Associates
  • Cohen & Hufford MD's INC
  • The Jones Clinic, PC
  • The Cleveland Clinic
  • Edmond Oncology Center
  • OU Medical Center
  • OU Physician's Building
  • University of Oklahoma
  • The Jones Clinic, PC
  • The Vanderbilt Clinic
  • University of Washington Medical Center
  • Virginia Mason Medical Center
  • Seattle Cancer Care Alliance
  • Centro Oncológico Rosario
  • Centro Medico San Roque
  • ISIS Clinica Especializado
  • Mater Adult Hospital
  • Royal Adelaide Hospital
  • Ashford Cancer Center Research
  • Cancer Care SA
  • Mater Private Hospital
  • ZNA Middelheim
  • Universitair Ziekenhuis Gent
  • Jessa Ziekenhuis - campus Virga Jessa
  • Cliniques Universitaires de Mont-Godinne UCL
  • Centro Goiano de Oncologia
  • Centro Goiano de Oncologia - CGO
  • ProCura - Centro Goiano de Pesquisa Clínica Ltda
  • Clínica de Oncologia de Porto Alegre Sociedade Simples Ltda
  • Instituto Nacional de Cancer - INCA
  • Associaçao Hospital de Caridade Ijui
  • Hospital de Clinicas de Porto Alegre
  • Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.
  • Fundação Pio XII - Hospital de Câncer de Barretos
  • Instituto de Oncologia de Piracicaba S/S Ltda
  • Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira - ICESP
  • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Instituto Nacional do Cancer - INCA
  • Odette Cancer Centre, Sunnybrook Health Sciences Centre
  • Centre de Sante et de Services Sociaux de Rimouski - Neigette
  • Instituto Nacional del Cancer
  • Fundacion Arturo Lopez Perez
  • Instituto Clinico Oncologico del Sur
  • Oncologos del Occidente S.A
  • Oblastni nemocnice Jicin a s
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc
  • Krajska zdravotni, a.s.
  • Centre Jean Perrin
  • Clinique Sainte Marguerite
  • Hopital Andre Mignot
  • Centre médical Oncogard
  • CHU de Poitiers
  • CHU de Rouen
  • Centre rené Gauducheau
  • Hopital Foch
  • Institut Gustave Roussy
  • Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH
  • Universitaetsklinikum Hamburg Eppendorf
  • Klinikum Region Hannover, Krankenhaus Siloah
  • TU Muenchen, rechts der Isar
  • Pamela Youde Nethersole Eastern Hospital
  • Prince of Wales Hospital
  • Queen Mary Hospital
  • Orszagos Onkologiai Intezet
  • Uzsoki Utcai Korhaz
  • Petz Aladar Megyei Oktato Korhaz
  • Josa Andras Oktato Korhaz Nonprofit Kft.
  • Szegedi Tudomanyegyetem, Urologiai Klinika
  • Veszprem Megyei Csolnoky Ferenc
  • Vedanta Institute of Medical Sciences
  • Healthcare Global Enterprises Limited
  • Lakeshore Hospital & Research Center Limited
  • Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology
  • Tata Memorial Center
  • Tata Memorial Centre
  • Jehangir Hospital
  • Searoc Cancer Centre
  • Apollo Hospital
  • Regional Cancer Centre
  • Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari
  • Sezione di Oncologia Medica Centro di Ricerca Clinica
  • Unità Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena
  • Farmacia del Comitato Etico Provinciale di Modena
  • Struttura Complessa di Oncologia Medica Ospedale Santa Maria della Misericordia
  • IFO- Istituti Fisioterapici Ospitalieri
  • Azienda Ospedaliera S. Maria
  • Samsung Medical Center
  • Yonsei University Health System-Severance Hospital
  • University Malaya Medical Centre
  • Hospital Aranda de la Parra
  • Spaarne Ziekenhuis
  • Uniwersyteckie Centrum Kliniczne
  • Szpital Specjalistyczny im. L. Rydygiera Sp. z o.o.
  • Centrum Onkologii Ziemi Lubelskiej im. sw Jana z Dukli
  • Szpital Kliniczny Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu
  • Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie
  • Centrum Medyczne Ostrobramska NZOZ "Magodent"
  • Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr
  • Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON
  • Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON
  • Hospital de San Joao
  • Hospital de São João
  • Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
  • Leningrad Regional Oncology Dispensary
  • Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic
  • Chair of Radiology and Radiotherapy
  • N.N. Blokhin Russian Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy
  • N.N. Blokhin Russian Cancer Research Center, Department of Urology
  • Moscow Scientific Research Oncology Institute P.A. Herzen
  • Privolzhskiy District Medical Center of Federal Biomedical Agency
  • Scientific research Institute of Oncology N.N. Petrov
  • City Hospital No.26
  • City Pokrovskaya Hospital
  • Clinical Center of Serbia
  • Institute for Oncology and Radiology of Serbia
  • Military Medical Academy
  • National Cancer Centre Singapore
  • Fakultna Nemocnica s poliklinikou F D Roosevelta
  • Oddelenie funkcnej diagnostiky
  • Klinika pneumologie a ftiziologie FNsP LFUK
  • Fakultna Nemocnica s poliklinikou akad L Derera
  • Klinica nuklcarncj mediciny
  • Klinika nuklearnej mediciny JLF UK a Martinskej fakultnej nemocnice
  • Klinika tuberkulozy a plucnych chorob UK JLF a Martinskej fakultnej nemocince
  • Nemocnica s poliklinikou Skalica
  • KK MED, s.r.o.
  • MEDIVASA s.r.o.
  • Nemocnica s poliklinikou Zilina
  • GVI Oncology Trial Unit
  • Westridge Medical Centre
  • Pretoria Urology Hospital
  • Panorama Medical Centre
  • University of the Witwatersrand Oncology
  • Langenhoven Drive Oncology Centre
  • Dr. Fourie & Voges
  • Institut Catala Doncologia
  • Hospital Universitario Marques de Valdecilla
  • Hospital Sant Creu I Sant Pau
  • Hospital del mar de Barcelona
  • Hospital de Madrid Norte-Sanchinarro
  • Instituto Valenciano de Oncología
  • Veterans General Hospital-Taipei
  • Tri-Service General Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Division of Oncology
  • Universitet, kafedra onkologyy
  • A.P Romodanov Itstitut nejrohirurhii
  • Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo
  • Donetskyy Oblasyy protypukhlynnyy Tsenter
  • Donetske Obl. clinico-teritorial'ne medichne ob'yednannya
  • "State Institution ""Institute for Occupational Health of the
  • R.E.Kavetsky Institute of experimental pathology, oncology and radiobiology NAS of Ukraine,Laborator
  • A.P Romodanov Itstitut nejrohirurhii
  • Oblasnyy onkologychnyy dispanser, onkourologichne viddilennya, Ivano-Frankivskiy Derzhavniy Medichni
  • Southampton General Hospital
  • Christie Hospital
  • University of Leeds
  • Guy's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
February 28, 2008
Last Updated
March 25, 2016
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00631371
Brief Title
Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
Acronym
INTORACT
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
temsirolimus, renal cell carcinoma, kidney cancer, urogenital cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
791 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
Arm Title
2
Arm Type
Active Comparator
Arm Description
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Torisel
Intervention Description
Bevacizumab 10 mg/kg intravenous (IV) q8wks
Intervention Type
Drug
Intervention Name(s)
Temsirolimus
Intervention Description
Temsirolimus 25 mg IV weekly
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 10 mg/kg intravenous (IV) q8wks
Intervention Type
Drug
Intervention Name(s)
Interferon-Alfa 9MU
Intervention Description
Interferon-Alfa 9MU SC TIW
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS): Independent-Assessment
Description
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.
Time Frame
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 Measure Information:
Title
Progression-Free Survival (PFS): Investigator-Assessment
Description
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.
Time Frame
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Title
Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment
Description
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.
Time Frame
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Title
Overall Survival (OS)
Description
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).
Time Frame
Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Hematology Oncology Services of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
South County Hematology/Oncology
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Cancer Center Oncology Medical Group
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1694
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6984
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
North County Oncology Medical Clinic
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Medical Oncology Associates - SD
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Memorial Hospital Investigational Pharmacy
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Rees-Stealy
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Pacific Hematology/Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Francisco Oncology Associates
City
San francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Cohen & Hufford MD's INC
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
The Jones Clinic, PC
City
New Albany
State/Province
Mississippi
ZIP/Postal Code
38652
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Edmond Oncology Center
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
OU Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
OU Physician's Building
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
The Jones Clinic, PC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The Vanderbilt Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
96195
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Centro Oncológico Rosario
City
Rosario
State/Province
Santa Fé
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Centro Medico San Roque
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Facility Name
ISIS Clinica Especializado
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
Mater Adult Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Ashford Cancer Center Research
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Cancer Care SA
City
Kurralta Park
ZIP/Postal Code
5037
Country
Australia
Facility Name
Mater Private Hospital
City
South Brisbane
ZIP/Postal Code
QLD 4101
Country
Australia
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Jessa Ziekenhuis - campus Virga Jessa
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Cliniques Universitaires de Mont-Godinne UCL
City
Mont-Godinne
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Centro Goiano de Oncologia
City
Goiania
State/Province
GO
ZIP/Postal Code
74075-040
Country
Brazil
Facility Name
Centro Goiano de Oncologia - CGO
City
Goiania
State/Province
GO
ZIP/Postal Code
74130-015
Country
Brazil
Facility Name
ProCura - Centro Goiano de Pesquisa Clínica Ltda
City
Goiania
State/Province
GO
ZIP/Postal Code
74140-050
Country
Brazil
Facility Name
Clínica de Oncologia de Porto Alegre Sociedade Simples Ltda
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90430-090
Country
Brazil
Facility Name
Instituto Nacional de Cancer - INCA
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Associaçao Hospital de Caridade Ijui
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-090
Country
Brazil
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto de Oncologia de Piracicaba S/S Ltda
City
Piracicaba
State/Province
SP
ZIP/Postal Code
13419-155
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Instituto Nacional do Cancer - INCA
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Odette Cancer Centre, Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Centre de Sante et de Services Sociaux de Rimouski - Neigette
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Instituto Nacional del Cancer
City
Santiago
State/Province
Region Metropolitana / Chile
ZIP/Postal Code
8380455
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez
City
Santiago
Country
Chile
Facility Name
Instituto Clinico Oncologico del Sur
City
Santiago
Country
Chile
Facility Name
Oncologos del Occidente S.A
City
Pereira
State/Province
Risaralda
Country
Colombia
Facility Name
Oblastni nemocnice Jicin a s
City
Jicin
State/Province
Ceska republika
ZIP/Postal Code
506 43
Country
Czech Republic
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czech Republic
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Krajska zdravotni, a.s.
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Clinique Sainte Marguerite
City
Hyères
ZIP/Postal Code
83400
Country
France
Facility Name
Hopital Andre Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Centre médical Oncogard
City
Nimes
ZIP/Postal Code
30907
Country
France
Facility Name
CHU de Poitiers
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
CHU de Rouen
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Centre rené Gauducheau
City
Saint-Herblain-Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Universitaetsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Klinikum Region Hannover, Krankenhaus Siloah
City
Hannover
ZIP/Postal Code
30449
Country
Germany
Facility Name
TU Muenchen, rechts der Isar
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Chai Wan
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Josa Andras Oktato Korhaz Nonprofit Kft.
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem, Urologiai Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Veszprem Megyei Csolnoky Ferenc
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Vedanta Institute of Medical Sciences
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380009
Country
India
Facility Name
Healthcare Global Enterprises Limited
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Facility Name
Lakeshore Hospital & Research Center Limited
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682304
Country
India
Facility Name
Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology
City
Bhopal
State/Province
Madhya Pradesh
ZIP/Postal Code
462001
Country
India
Facility Name
Tata Memorial Center
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Tata Memorial Centre
City
Navi Mumbai
State/Province
Maharashtra
ZIP/Postal Code
410210
Country
India
Facility Name
Jehangir Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Searoc Cancer Centre
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302013
Country
India
Facility Name
Apollo Hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600035
Country
India
Facility Name
Regional Cancer Centre
City
Kerela
State/Province
Trivandrum
ZIP/Postal Code
695011
Country
India
Facility Name
Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Sezione di Oncologia Medica Centro di Ricerca Clinica
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
Unità Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Farmacia del Comitato Etico Provinciale di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Struttura Complessa di Oncologia Medica Ospedale Santa Maria della Misericordia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
IFO- Istituti Fisioterapici Ospitalieri
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Yonsei University Health System-Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Aranda de la Parra
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Spaarne Ziekenhuis
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80952
Country
Poland
Facility Name
Szpital Specjalistyczny im. L. Rydygiera Sp. z o.o.
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. sw Jana z Dukli
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Centrum Medyczne Ostrobramska NZOZ "Magodent"
City
Warszawa
ZIP/Postal Code
04-125
Country
Poland
Facility Name
Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Hospital de San Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Hospital de São João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
City
Obninsk
State/Province
Kaluga region
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Dispensary
City
Saint-Petersburg
State/Province
Leningradskaya oblast
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Chair of Radiology and Radiotherapy
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
N.N. Blokhin Russian Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
N.N. Blokhin Russian Cancer Research Center, Department of Urology
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Moscow Scientific Research Oncology Institute P.A. Herzen
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Privolzhskiy District Medical Center of Federal Biomedical Agency
City
Nizhni Novgorod
ZIP/Postal Code
603109
Country
Russian Federation
Facility Name
Scientific research Institute of Oncology N.N. Petrov
City
Pesochny, Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
City Hospital No.26
City
Saint-Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
City Pokrovskaya Hospital
City
Saint-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Oncology and Radiology of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Fakultna Nemocnica s poliklinikou F D Roosevelta
City
Banska Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
Oddelenie funkcnej diagnostiky
City
Banska Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
Klinika pneumologie a ftiziologie FNsP LFUK
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Fakultna Nemocnica s poliklinikou akad L Derera
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Klinica nuklcarncj mediciny
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Klinika nuklearnej mediciny JLF UK a Martinskej fakultnej nemocnice
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Klinika tuberkulozy a plucnych chorob UK JLF a Martinskej fakultnej nemocince
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Nemocnica s poliklinikou Skalica
City
Skalica
ZIP/Postal Code
909 82
Country
Slovakia
Facility Name
KK MED, s.r.o.
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
MEDIVASA s.r.o.
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Nemocnica s poliklinikou Zilina
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
GVI Oncology Trial Unit
City
Kraaifontein
State/Province
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Westridge Medical Centre
City
Mayville
State/Province
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Pretoria Urology Hospital
City
Hatfield
State/Province
Pretoria
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Panorama Medical Centre
City
Panorama, Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
University of the Witwatersrand Oncology
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Langenhoven Drive Oncology Centre
City
Port Elizabeth
ZIP/Postal Code
6006
Country
South Africa
Facility Name
Dr. Fourie & Voges
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Institut Catala Doncologia
City
L'hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Sant Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital del mar de Barcelona
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hospital de Madrid Norte-Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Veterans General Hospital-Taipei
City
Taipei
State/Province
ROC
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Neihu
State/Province
Tapei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei TOC
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Division of Oncology
City
Tao Yuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Universitet, kafedra onkologyy
City
Chenivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
A.P Romodanov Itstitut nejrohirurhii
City
Chernovtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo
City
Donetsk
ZIP/Postal Code
83003
Country
Ukraine
Facility Name
Donetskyy Oblasyy protypukhlynnyy Tsenter
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Donetske Obl. clinico-teritorial'ne medichne ob'yednannya
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
"State Institution ""Institute for Occupational Health of the
City
Kiev
ZIP/Postal Code
01033
Country
Ukraine
Facility Name
R.E.Kavetsky Institute of experimental pathology, oncology and radiobiology NAS of Ukraine,Laborator
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
A.P Romodanov Itstitut nejrohirurhii
City
Kiyv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Oblasnyy onkologychnyy dispanser, onkourologichne viddilennya, Ivano-Frankivskiy Derzhavniy Medichni
City
Medychna vul., Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Christie Hospital
City
Withington
State/Province
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
University of Leeds
City
Leeds
State/Province
North Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28410911
Citation
de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
Results Reference
derived
PubMed Identifier
27238653
Citation
Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
Results Reference
derived
PubMed Identifier
24297945
Citation
Rini BI, Bellmunt J, Clancy J, Wang K, Niethammer AG, Hariharan S, Escudier B. Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol. 2014 Mar 10;32(8):752-9. doi: 10.1200/JCO.2013.50.5305. Epub 2013 Dec 2.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3066K1-3311&StudyName=Study%20Comparing%20Bevacizumab%20+%20Temsirolimus%20vs.%20Bevacizumab%20+%20Interferon-Alfa%20In%20Advanced%20Renal%20Cell%20Carcinoma%20Subjects
Description
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Learn more about this trial

Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects

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