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Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib (INTORSECT)

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sorafenib
temsirolimus (Torisel)
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 Metastatic or Advanced Renal Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
  • At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.

  • At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions.

    • More criteria apply

Exclusion Criteria:

  • Metastatic CNS from RCC.
  • Subjects who discontinued Sutent therapy due specifically to intolerance.
  • Prior systemic therapy for mRCC other than sunitinib.

  • Active ketonuria, secondary to poorly controlled diabetes mellitus

    • More criteria apply

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.

Secondary Outcome Measures

Progression Free Survival (PFS) by Investigator Assessment
Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.
Percentage of Participants With Tumor Response
Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Overall Survival (OS)
Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment
PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.
Duration of Response (DR)
Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.

Full Information

First Posted
May 15, 2007
Last Updated
October 28, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00474786
Brief Title
Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib
Acronym
INTORSECT
Official Title
A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2013 (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
This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).
Intervention Type
Drug
Intervention Name(s)
temsirolimus (Torisel)
Intervention Description
Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.
Time Frame
Baseline up to 24 Months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) by Investigator Assessment
Description
Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.
Time Frame
Baseline up to 24 Months
Title
Percentage of Participants With Tumor Response
Description
Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Time Frame
Baseline up to 24 Months
Title
Overall Survival (OS)
Description
Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Time Frame
Baseline to date of death from any cause (up to 24 months)
Title
Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment
Description
PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.
Time Frame
Weeks 12, 24, and 36
Title
Duration of Response (DR)
Description
Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.
Time Frame
Baseline up to 24 Months
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame
Baseline up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously). At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery. At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions. More criteria apply Exclusion Criteria: Metastatic CNS from RCC. Subjects who discontinued Sutent therapy due specifically to intolerance. Prior systemic therapy for mRCC other than sunitinib. Active ketonuria, secondary to poorly controlled diabetes mellitus More criteria apply
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
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6984
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pfizer Investigational Site
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pfizer Investigational Site
City
Meriden
State/Province
Connecticut
ZIP/Postal Code
06451
Country
United States
Facility Name
Pfizer Investigational Site
City
Municie
State/Province
Indiana
ZIP/Postal Code
47303
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
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Pfizer Investigational Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
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
73120
Country
United States
Facility Name
Pfizer Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5550
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84412
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
Rosario
State/Province
Santa Fé
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1122AAL
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1437JCP
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Nueva Cordoba
ZIP/Postal Code
X5006HBF
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Tucuman
ZIP/Postal Code
T4000 IAK
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
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
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
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
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
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Pfizer Investigational Site
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Pfizer Investigational Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
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 4E6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
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
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Cornwall
State/Province
Ontario
ZIP/Postal Code
K6R 5S5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
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
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4K7
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
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Hong Kong
Country
China
Facility Name
Pfizer Investigational Site
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33 521
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
20 520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Montpellier
State/Province
Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Pfizer Investigational Site
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Pfizer Investigational Site
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Pfizer Investigational Site
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Pfizer Investigational Site
City
Caen Cedex 05
ZIP/Postal Code
14076
Country
France
Facility Name
Pfizer Investigational Site
City
Clermont-Ferrand Cedex 1
ZIP/Postal Code
63011
Country
France
Facility Name
Pfizer Investigational Site
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Pfizer Investigational Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Pfizer Investigational Site
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Herlain/Nantes Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Pfizer Investigational Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Pfizer Investigational Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Pfizer Investigational Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Pfizer Investigational Site
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Pfizer Investigational Site
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Pfizer Investigational Site
City
Neuss
ZIP/Postal Code
41464
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
H-1122
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
0144
Country
Italy
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
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
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
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
28007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Göteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Kleinriehenstrasse 30
State/Province
Basel
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Basel
State/Province
BS
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Geneva
State/Province
GE
ZIP/Postal Code
1221
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Basel
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Bruderholz
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Rheinstrasse 26
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B5 7UG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Withington
State/Province
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 6BE
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
24297950
Citation
Hutson TE, Escudier B, Esteban E, Bjarnason GA, Lim HY, Pittman KB, Senico P, Niethammer A, Lu DR, Hariharan S, Motzer RJ. Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2014 Mar 10;32(8):760-7. doi: 10.1200/JCO.2013.50.3961. Epub 2013 Dec 2.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3066K1-404&StudyName=Temsirolimus%20Versus%20Sorafenib%20As%20Second-Line%20Therapy%20In%20Patients%20With%20Advanced%20RCC%20%20Who%20Have%20Failed%20First-Line%20Sunitinib
Description
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Learn more about this trial

Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

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