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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00474786




Registration number
NCT00474786
Ethics application status
Date submitted
15/05/2007
Date registered
17/05/2007
Date last updated
21/11/2013

Titles & IDs
Public title
Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib
Scientific 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
Secondary ID [1] 0 0
B1771003
Secondary ID [2] 0 0
3066K1-404
Universal Trial Number (UTN)
Trial acronym
INTORSECT
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sorafenib
Treatment: Drugs - temsirolimus (Torisel)

Experimental: 1 -

Experimental: 2 -


Treatment: Drugs: Sorafenib
Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).

Treatment: Drugs: temsirolimus (Torisel)
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Baseline up to 24 Months
Secondary outcome [1] 0 0
Progression Free Survival (PFS) by Investigator Assessment
Timepoint [1] 0 0
Baseline up to 24 Months
Secondary outcome [2] 0 0
Percentage of Participants With Tumor Response
Timepoint [2] 0 0
Baseline up to 24 Months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Baseline to date of death from any cause (up to 24 months)
Secondary outcome [4] 0 0
Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment
Timepoint [4] 0 0
Weeks 12, 24, and 36
Secondary outcome [5] 0 0
Duration of Response (DR)
Timepoint [5] 0 0
Baseline up to 24 Months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
512
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Kogarah
Recruitment hospital [2] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [4] 0 0
Pfizer Investigational Site - South Brisbane
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Elizabeth Vale
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Woodville South
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Argentina
State/province [14] 0 0
Santa Fé
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Nueva Cordoba
Country [17] 0 0
Argentina
State/province [17] 0 0
Tucuman
Country [18] 0 0
Austria
State/province [18] 0 0
Salzburg
Country [19] 0 0
Austria
State/province [19] 0 0
Wien
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Chile
State/province [25] 0 0
Santiago
Country [26] 0 0
China
State/province [26] 0 0
Hong Kong
Country [27] 0 0
Denmark
State/province [27] 0 0
Aarhus C
Country [28] 0 0
Denmark
State/province [28] 0 0
Herlev
Country [29] 0 0
Finland
State/province [29] 0 0
Tampere
Country [30] 0 0
Finland
State/province [30] 0 0
Turku
Country [31] 0 0
France
State/province [31] 0 0
Cedex 5
Country [32] 0 0
France
State/province [32] 0 0
Angers
Country [33] 0 0
France
State/province [33] 0 0
Besancon
Country [34] 0 0
France
State/province [34] 0 0
Bordeaux
Country [35] 0 0
France
State/province [35] 0 0
Caen Cedex 05
Country [36] 0 0
France
State/province [36] 0 0
Clermont-Ferrand Cedex 1
Country [37] 0 0
France
State/province [37] 0 0
Dijon
Country [38] 0 0
France
State/province [38] 0 0
Lille
Country [39] 0 0
France
State/province [39] 0 0
Lyon Cedex 08
Country [40] 0 0
France
State/province [40] 0 0
Marseille Cedex 9
Country [41] 0 0
France
State/province [41] 0 0
Paris Cedex 15
Country [42] 0 0
France
State/province [42] 0 0
Poitiers Cedex
Country [43] 0 0
France
State/province [43] 0 0
Saint Herlain/Nantes Cedex
Country [44] 0 0
France
State/province [44] 0 0
Strasbourg
Country [45] 0 0
France
State/province [45] 0 0
Vandoeuvre Les Nancy
Country [46] 0 0
France
State/province [46] 0 0
Villejuif Cedex
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Germany
State/province [48] 0 0
Dresden
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Germany
State/province [49] 0 0
Heidelberg
Country [50] 0 0
Germany
State/province [50] 0 0
Kassel
Country [51] 0 0
Germany
State/province [51] 0 0
Luebeck
Country [52] 0 0
Germany
State/province [52] 0 0
Muenchen
Country [53] 0 0
Germany
State/province [53] 0 0
Neuss
Country [54] 0 0
Germany
State/province [54] 0 0
Ulm
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Italy
State/province [56] 0 0
Chieti
Country [57] 0 0
Italy
State/province [57] 0 0
Firenze
Country [58] 0 0
Italy
State/province [58] 0 0
Napoli
Country [59] 0 0
Italy
State/province [59] 0 0
Pavia
Country [60] 0 0
Italy
State/province [60] 0 0
Roma
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Seoul
Country [62] 0 0
Netherlands
State/province [62] 0 0
Dordrecht
Country [63] 0 0
Netherlands
State/province [63] 0 0
Leeuwarden
Country [64] 0 0
Netherlands
State/province [64] 0 0
Zwolle
Country [65] 0 0
Singapore
State/province [65] 0 0
Singapore
Country [66] 0 0
Spain
State/province [66] 0 0
Asturias
Country [67] 0 0
Spain
State/province [67] 0 0
Barcelona
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Spain
State/province [69] 0 0
Sevilla
Country [70] 0 0
Spain
State/province [70] 0 0
Valencia
Country [71] 0 0
Sweden
State/province [71] 0 0
Göteborg
Country [72] 0 0
Sweden
State/province [72] 0 0
Lund
Country [73] 0 0
Sweden
State/province [73] 0 0
Malmo
Country [74] 0 0
Switzerland
State/province [74] 0 0
Basel
Country [75] 0 0
Switzerland
State/province [75] 0 0
BS
Country [76] 0 0
Switzerland
State/province [76] 0 0
GE
Country [77] 0 0
Switzerland
State/province [77] 0 0
Bruderholz
Country [78] 0 0
Switzerland
State/province [78] 0 0
Luzern
Country [79] 0 0
Switzerland
State/province [79] 0 0
Rheinstrasse 26
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Birmingham
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Cambridgeshire
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Manchester
Country [83] 0 0
United Kingdom
State/province [83] 0 0
London
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Newcastle upon Tyne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00474786