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Renal Cell CarcinomaPhase 3INTORSECTNCT00474786

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

A Phase 3 study testing Sorafenib and temsirolimus (Torisel) in people with Renal Cell Carcinoma, run by Pfizer at 128 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Sorafenib and temsirolimus (Torisel)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
512 participants
Where
128 sitesin 20 countries
Study dates
Sep 2007to Jan 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

128 sites in 20 countries.

128 sites in 20 countries

United States26 sites

  • Pfizer Investigational Site

    Austin, Texas, 78731

  • Pfizer Investigational Site

    Baltimore, Maryland, 21201

  • Pfizer Investigational Site

    Bethesda, Maryland, 20817

  • Pfizer Investigational Site

    Cleveland, Ohio, 44195

  • Pfizer Investigational Site

    Dallas, Texas, 75226

  • Pfizer Investigational Site

    Dallas, Texas, 75246

  • Pfizer Investigational Site

    Duarte, California, 91010

  • Pfizer Investigational Site

    La Jolla, California, 92037

  • Pfizer Investigational Site

    La Jolla, California, 92093

  • Pfizer Investigational Site

    Los Angeles, California, 90095-6984

  • Pfizer Investigational Site

    Los Angeles, California, 90095

  • Pfizer Investigational Site

    Louisville, Kentucky, 40202

  • Pfizer Investigational Site

    Meriden, Connecticut, 06451

  • Pfizer Investigational Site

    Metairie, Louisiana, 70006

  • Pfizer Investigational Site

    Municie, Indiana, 47303

  • Pfizer Investigational Site

    New York, New York, 10065

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73120

  • Pfizer Investigational Site

    Orange, California, 92868

  • Pfizer Investigational Site

    Riverside, California, 92505

  • Pfizer Investigational Site

    Salt Lake City, Utah, 84112-5550

  • Pfizer Investigational Site

    Salt Lake City, Utah, 84412

  • Pfizer Investigational Site

    San Antonio, Texas, 78229

  • Pfizer Investigational Site

    San Diego, California, 92103

  • Pfizer Investigational Site

    Seattle, Washington, 98101

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74104

  • Pfizer Investigational Site

    Tupelo, Mississippi, 38801

Other trials in United States

Canada16 sites

  • Pfizer Investigational Site

    Cornwall, Ontario, K6R 5S5

  • Pfizer Investigational Site

    Edmonton, Alberta, T6G 1Z2

  • Pfizer Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • Pfizer Investigational Site

    Halifax, Nova Scotia, B3H 2Y9

  • Pfizer Investigational Site

    Halifax, Nova Scotia, B3H 3A7

  • Pfizer Investigational Site

    Hamilton, Ontario, L8N 4A6

  • Pfizer Investigational Site

    Kelowna, British Columbia, V1Y 5L3

  • Pfizer Investigational Site

    London, Ontario, N6A 4G5

  • Pfizer Investigational Site

    London, Ontario, N6A 4L6

  • Pfizer Investigational Site

    Montreal, Quebec, H3G 1A4

  • Pfizer Investigational Site

    Ottawa, Ontario, K1H 8L6

  • Pfizer Investigational Site

    Ottawa, Ontario, K1Y 4K7

  • Pfizer Investigational Site

    Toronto, Ontario, M4N 3M5

  • Pfizer Investigational Site

    Toronto, Ontario, M5G 2M9

  • Pfizer Investigational Site

    Vancouver, British Columbia, V5Z 4E6

  • Pfizer Investigational Site

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

France16 sites

  • Pfizer Investigational Site

    Angers, 49100

  • Pfizer Investigational Site

    Besançon, 25000

  • Pfizer Investigational Site

    Bordeaux, 33075

  • Pfizer Investigational Site

    Caen, 14076

  • Pfizer Investigational Site

    Clermont-Ferrand, 63011

  • Pfizer Investigational Site

    Dijon, 21079

  • Pfizer Investigational Site

    Lille, 59000

  • Pfizer Investigational Site

    Lyon, 69373

  • Pfizer Investigational Site

    Marseille, 13273

  • Pfizer Investigational Site

    Montpellier, Cedex 5, 34298

  • Pfizer Investigational Site

    Paris, 75908

  • Pfizer Investigational Site

    Poitiers, 86021

  • Pfizer Investigational Site

    Saint Herlain/Nantes Cedex, 44805

  • Pfizer Investigational Site

    Strasbourg, 67091

  • Pfizer Investigational Site

    Vandœuvre-lès-Nancy, 54511

  • Pfizer Investigational Site

    Villejuif, 94805

Other trials in France

Germany8 sites

  • Pfizer Investigational Site

    Berlin, 10117

  • Pfizer Investigational Site

    Dresden, 01307

  • Pfizer Investigational Site

    Heidelberg, 69120

  • Pfizer Investigational Site

    Kassel, 34125

  • Pfizer Investigational Site

    Lübeck, 23538

  • Pfizer Investigational Site

    München, 81675

  • Pfizer Investigational Site

    Neuss, 41464

  • Pfizer Investigational Site

    Ulm, 89081

Other trials in Germany

Spain8 sites

  • Pfizer Investigational Site

    Badalona, Barcelona, 08916

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08025

  • Pfizer Investigational Site

    Madrid, Madrid, 28007

  • Pfizer Investigational Site

    Madrid, Madrid, 28041

  • Pfizer Investigational Site

    Oviedo, Principality of Asturias, 33006

  • Pfizer Investigational Site

    Sabadell, Barcelona, 08208

  • Pfizer Investigational Site

    Seville, Sevilla, 41013

  • Pfizer Investigational Site

    Valencia, Valencia, 46010

Other trials in Spain

Australia7 sites

  • Pfizer Investigational Site

    Adelaide, South Australia, 5000

  • Pfizer Investigational Site

    Elizabeth Vale, South Australia, 5112

  • Pfizer Investigational Site

    Kogarah, New South Wales, 2217

  • Pfizer Investigational Site

    South Brisbane, Queensland, 4101

  • Pfizer Investigational Site

    St Leonards, New South Wales, 2065

  • Pfizer Investigational Site

    Westmead, New South Wales, 2145

  • Pfizer Investigational Site

    Woodville South, South Australia, 5011

Other trials in Australia

Italy7 sites

  • Pfizer Investigational Site

    Chieti, 66013

  • Pfizer Investigational Site

    Florence, 50134

  • Pfizer Investigational Site

    Naples, 80131

  • Pfizer Investigational Site

    Pavia, 27100

  • Pfizer Investigational Site

    Roma, 00144

  • Pfizer Investigational Site

    Roma, 00152

  • Pfizer Investigational Site

    Roma, 0144

Other trials in Italy

Switzerland7 sites

  • Pfizer Investigational Site

    Basel, Canton of Basel-City, 4031

  • Pfizer Investigational Site

    Basel

  • Pfizer Investigational Site

    Bruderholz

  • Pfizer Investigational Site

    Geneva, Canton of Geneva, 1221

  • Pfizer Investigational Site

    Kleinriehenstrasse 30, Basel

  • Pfizer Investigational Site

    Lucerne, 6000

  • Pfizer Investigational Site

    Rheinstrasse 26

Other trials in Switzerland

United Kingdom7 sites

  • Pfizer Investigational Site

    Birmingham, B15 2TH

  • Pfizer Investigational Site

    Cambridge, Cambridgeshire, CB2 0QQ

  • Pfizer Investigational Site

    Edgbaston, Birmingham, B5 7UG

  • Pfizer Investigational Site

    London, SE1 9RT

  • Pfizer Investigational Site

    Manchester, M23 9LT

  • Pfizer Investigational Site

    Newcastle upon Tyne, NE4 6BE

  • Pfizer Investigational Site

    Withington, Manchester, M20 4BX

Other trials in United Kingdom

Argentina6 sites

  • Pfizer Investigational Site

    Buenos Aires, Buenos Aires, C1426ANZ

  • Pfizer Investigational Site

    Buenos Aires, C1122AAL

  • Pfizer Investigational Site

    Buenos Aires, C1437JCP

  • Pfizer Investigational Site

    Nueva Cordoba, X5006HBF

  • Pfizer Investigational Site

    Rosario, Santa Fe Province, S2000KZE

  • Pfizer Investigational Site

    San Miguel de Tucumán, T4000 IAK

Other trials in Argentina

South Korea4 sites

  • Pfizer Investigational Site

    Seoul, 110-744

  • Pfizer Investigational Site

    Seoul, 120-752

  • Pfizer Investigational Site

    Seoul, 135-710

  • Pfizer Investigational Site

    Seoul, 138-736

Other trials in South Korea

Netherlands3 sites

  • Pfizer Investigational Site

    Dordrecht, 3318 AT

  • Pfizer Investigational Site

    Leeuwarden, 8934 AD

  • Pfizer Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Sweden3 sites

  • Pfizer Investigational Site

    Gothenburg, SE-413 45

  • Pfizer Investigational Site

    Lund, 221 85

  • Pfizer Investigational Site

    Malmö, 205 02

Other trials in Sweden

Austria2 sites

  • Pfizer Investigational Site

    Salzburg, 5020

  • Pfizer Investigational Site

    Vienna, Austria, 1090

Other trials in Austria

Denmark2 sites

  • Pfizer Investigational Site

    Aarhus C, 8000

  • Pfizer Investigational Site

    Herlev, 2730

Other trials in Denmark

Finland2 sites

  • Pfizer Investigational Site

    Tampere, 33 521

  • Pfizer Investigational Site

    Turku, 20 520

Other trials in Finland

Chile1 site

  • Pfizer Investigational Site

    Providencia, Santiago Metropolitan

Other trials in Chile

China1 site

  • Pfizer Investigational Site

    Hong Kong

Other trials in China

Hungary1 site

  • Pfizer Investigational Site

    Budapest, H-1122

Other trials in Hungary

Singapore1 site

  • Pfizer Investigational Site

    Singapore, 169610

Other trials in Singapore

About this study

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

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.

Being tested
Sorafenib, temsirolimus (Torisel)
Keywords
Metastatic or Advanced Renal Cell Carcinoma
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorafenibDrug

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

  • temsirolimus (Torisel)Drug

    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.

Study groups in NCT00474786
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Sorafenib
2ExperimentalNot described
Receives: Drug: temsirolimus (Torisel)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to 24 Months

Secondary outcomes (5)

  1. 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.

    Measured: Baseline up to 24 Months

  2. 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.

    Measured: Baseline up to 24 Months

  3. 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.

    Measured: Baseline to date of death from any cause (up to 24 months)

  4. 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.

    Measured: Weeks 12, 24, and 36

  5. 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.

    Measured: Baseline up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionJan 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00474786
Sponsor's protocol ID
3066K1-404
Other IDs
B1771003
Acronym
INTORSECT
Status last verified
Oct 2013
First submitted
15 May 2007
Last updated
21 Nov 2013
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28410911

  • 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.

    PubMed 27238653

  • 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.

    PubMed 24297950

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib and temsirolimus (Torisel) in people with Renal Cell Carcinoma, run by Pfizer at 128 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, Canada, France, Germany, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Baseline up to 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00474786, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.

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