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Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma (ARCC)

Primary Purpose

Carcinoma, Renal Cell, Kidney Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Interferon Alfa
CCI-779
Interferon Alfa and CCI-779
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Advanced Renal Cell Carcinoma, Kidney Cancer

Eligibility Criteria

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

Inclusion Criteria: This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease, Exclusion Criteria: Subjects with central nervous system (CNS) metastases Prior anticancer therapy for RCC Prior investigational therapy/agents within 4 weeks of randomization

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

Secondary Outcome Measures

Progression-Free Survival (PFS)
PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.
Percentage of Participants With Objective Response
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Percentage of Participants With Clinical Benefit
Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Duration of Response (DR)
DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.
Time to Treatment Failure (TTF)
TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.
Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)
The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the "dispersion" of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.
European Quality of Life Health Questionnaire (EQ-5D) - Index Score
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.

Full Information

First Posted
July 24, 2003
Last Updated
September 24, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00065468
Brief Title
Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
Acronym
ARCC
Official Title
A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
March 2011 (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
The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus], administered intravenously [IV] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Kidney Neoplasms
Keywords
Advanced Renal Cell Carcinoma, Kidney Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Interferon Alfa
Intervention Description
Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter.
Intervention Type
Drug
Intervention Name(s)
CCI-779
Intervention Description
25 mg of CCI-779 given Intra Venously once per week
Intervention Type
Drug
Intervention Name(s)
Interferon Alfa and CCI-779
Intervention Description
15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
Time Frame
Baseline up to Month 80
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.
Time Frame
Baseline, monthly until tumor progression or death (up to Month 80)
Title
Percentage of Participants With Objective Response
Description
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame
Baseline, every 2 months until tumor progression or death (up to Month 80)
Title
Percentage of Participants With Clinical Benefit
Description
Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame
Baseline, every 2 months until tumor progression or death (up to Month 80)
Title
Duration of Response (DR)
Description
DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.
Time Frame
Baseline, every month until tumor progression or death (up to Month 80)
Title
Time to Treatment Failure (TTF)
Description
TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.
Time Frame
Baseline, every month until tumor progression or death (up to Month 80)
Title
Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)
Description
The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the "dispersion" of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.
Time Frame
Baseline to Month 80
Title
European Quality of Life Health Questionnaire (EQ-5D) - Index Score
Description
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease, Exclusion Criteria: Subjects with central nervous system (CNS) metastases Prior anticancer therapy for RCC Prior investigational therapy/agents within 4 weeks of randomization
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
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pfizer Investigational Site
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024-2828
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Pfizer Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Pfizer Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3824
Country
United States
Facility Name
Pfizer Investigational Site
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46303
Country
United States
Facility Name
Pfizer Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Pfizer Investigational Site
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7136
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-1000
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Pfizer Investigational Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Pfizer Investigational Site
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Pfizer Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Pfizer Investigational Site
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Pfizer Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Pfizer Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Pfizer Investigational Site
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pfizer Investigational Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2933
Country
United States
Facility Name
Pfizer Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Pfizer Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6310
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Pfizer Investigational Site
City
Buenos
State/Province
Aires
Country
Argentina
Facility Name
Pfizer Investigational Site
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Mendoza
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Quilmes
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Pfizer Investigational Site
City
Newcastle
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3012
Country
Australia
Facility Name
Pfizer Investigational Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Pfizer Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3J5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0C9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton, Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
656 53
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Prague 5
ZIP/Postal Code
150 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Sremska Kamenica
State/Province
Novi Sad
ZIP/Postal Code
21204
Country
Former Serbia and Montenegro
Facility Name
Pfizer Investigational Site
City
Bonn
State/Province
NRW
ZIP/Postal Code
53105
Country
Germany
Facility Name
Pfizer Investigational Site
City
Essen
State/Province
NRW
ZIP/Postal Code
45122
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
State/Province
RP
ZIP/Postal Code
D-55101
Country
Germany
Facility Name
Pfizer Investigational Site
City
Heraklion
State/Province
Creete
Country
Greece
Facility Name
Pfizer Investigational Site
City
Patra
Country
Greece
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
H-1122
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Roma
State/Province
RM
ZIP/Postal Code
00144
Country
Italy
Facility Name
Pfizer Investigational Site
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Daugavpils
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
2021
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Leon Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Nijmegen
State/Province
GA
ZIP/Postal Code
6525
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Pfizer Investigational Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Pfizer Investigational Site
City
Opole
ZIP/Postal Code
45-060
Country
Poland
Facility Name
Pfizer Investigational Site
City
Poznan
ZIP/Postal Code
61-878
Country
Poland
Facility Name
Pfizer Investigational Site
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Pfizer Investigational Site
City
Barnaul
ZIP/Postal Code
656052
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Kemerovo
ZIP/Postal Code
650003
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Ufa
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Banska Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Zlina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6006
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2197
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Gauteng
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Taipei
State/Province
ROC
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Istanbul
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Dnietropetrovsk
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Donetsk
ZIP/Postal Code
83 092
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkov
ZIP/Postal Code
61 037
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kiev
ZIP/Postal Code
03 142
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Zaporozhye
ZIP/Postal Code
69103
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Pfizer Investigational Site

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
25577718
Citation
Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
Results Reference
derived
PubMed Identifier
17538086
Citation
Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81. doi: 10.1056/NEJMoa066838.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3066K1-304&StudyName=Study%20Evaluating%20Interferon%20And%20CCI-779%20In%20Advanced%20Renal%20Cell%20Carcinoma
Description
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Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma

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