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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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California
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United States of America
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Connecticut
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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Maryland
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Mississippi
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New York
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Ohio
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Oklahoma
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Texas
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United States of America
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Utah
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United States of America
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Washington
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Argentina
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Santa Fé
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Argentina
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Buenos Aires
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Argentina
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Nueva Cordoba
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Argentina
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Tucuman
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Austria
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Salzburg
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Austria
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Wien
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Canada
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Alberta
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British Columbia
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Nova Scotia
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Ontario
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Quebec
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Chile
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Santiago
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China
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Hong Kong
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Aarhus C
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Denmark
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Herlev
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Tampere
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Finland
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Turku
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France
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Cedex 5
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Angers
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France
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Besancon
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Bordeaux
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Clermont-Ferrand Cedex 1
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Dijon
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Lille
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Lyon Cedex 08
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Marseille Cedex 9
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France
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Paris Cedex 15
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France
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Poitiers Cedex
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Saint Herlain/Nantes Cedex
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Strasbourg
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Vandoeuvre Les Nancy
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Heidelberg
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Kassel
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Luebeck
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Muenchen
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Neuss
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Ulm
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Hungary
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Budapest
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Chieti
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Italy
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Firenze
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Italy
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Napoli
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Italy
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Pavia
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Italy
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Roma
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Korea, Republic of
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Seoul
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Netherlands
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Dordrecht
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Zwolle
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Singapore
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Asturias
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Barcelona
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Madrid
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Sevilla
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Spain
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Valencia
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Sweden
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Göteborg
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Sweden
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Lund
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Sweden
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Malmo
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Switzerland
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Basel
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BS
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Switzerland
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GE
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Switzerland
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Bruderholz
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Switzerland
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Luzern
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Switzerland
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Rheinstrasse 26
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United Kingdom
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Birmingham
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United Kingdom
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Cambridgeshire
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Manchester
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London
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United Kingdom
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Newcastle upon Tyne

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00474786
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00474786