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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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) - 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.
Timepoint [1] 0 0
Baseline up to 24 Months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline up to 24 Months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline up to 24 Months
Secondary outcome [3] 0 0
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.
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 - 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.
Timepoint [4] 0 0
Weeks 12, 24, and 36
Secondary outcome [5] 0 0
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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
State/province [2] 0 0
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
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
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United States of America
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Maryland
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United States of America
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Mississippi
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Texas
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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
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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
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
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Canada
State/province [24] 0 0
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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Denmark
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Aarhus C
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Denmark
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Herlev
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Finland
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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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France
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Angers
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France
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Besancon
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France
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Bordeaux
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France
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Caen Cedex 05
Country [36] 0 0
France
State/province [36] 0 0
Clermont-Ferrand Cedex 1
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France
State/province [37] 0 0
Dijon
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France
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Lille
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France
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Lyon Cedex 08
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France
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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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France
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Saint Herlain/Nantes Cedex
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Strasbourg
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France
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Vandoeuvre Les Nancy
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France
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Villejuif Cedex
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Heidelberg
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Germany
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Kassel
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Germany
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Luebeck
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Germany
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Muenchen
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Germany
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Neuss
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Germany
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Ulm
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Hungary
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Budapest
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Italy
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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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Netherlands
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Leeuwarden
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Netherlands
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Zwolle
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Singapore
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Singapore
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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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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Switzerland
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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
State/province [80] 0 0
Birmingham
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United Kingdom
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Cambridgeshire
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United Kingdom
State/province [82] 0 0
Manchester
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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
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/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
Other publications