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

NCT ID: NCT00474786

Last Updated: 2013-11-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Keywords

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Metastatic or Advanced Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Sorafenib

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

temsirolimus (Torisel)

Intervention Type 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.

Interventions

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Sorafenib

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

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 Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Duarte, California, United States

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La Jolla, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Meriden, Connecticut, United States

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Municie, Indiana, United States

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Louisville, Kentucky, United States

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Metairie, Louisiana, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Tupelo, Mississippi, United States

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New York, New York, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Seattle, Washington, United States

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Buenos Aires, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Nueva Cordoba, , Argentina

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San Miguel de Tucumán, , Argentina

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Kogarah, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Westmead, New South Wales, Australia

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South Brisbane, Queensland, Australia

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Adelaide, South Australia, Australia

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Elizabeth Vale, South Australia, Australia

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Woodville South, South Australia, Australia

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Vienna, Austria, Austria

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Salzburg, , Austria

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Cornwall, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Providencia, Santiago Metropolitan, Chile

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Hong Kong, , China

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Aarhus C, , Denmark

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Herlev, , Denmark

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Tampere, , Finland

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Turku, , Finland

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Montpellier, Cedex 5, France

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Angers, , France

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Besançon, , France

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Bordeaux, , France

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Caen, , France

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Clermont-Ferrand, , France

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Dijon, , France

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Lille, , France

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Lyon, , France

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Marseille, , France

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Paris, , France

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Poitiers, , France

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Saint Herlain/Nantes Cedex, , France

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Strasbourg, , France

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Vandœuvre-lès-Nancy, , France

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Villejuif, , France

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Berlin, , Germany

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Dresden, , Germany

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Heidelberg, , Germany

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Kassel, , Germany

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Lübeck, , Germany

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München, , Germany

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Neuss, , Germany

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Ulm, , Germany

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Budapest, , Hungary

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Chieti, , Italy

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Florence, , Italy

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Napoli, , Italy

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Pavia, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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Dordrecht, , Netherlands

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Leeuwarden, , Netherlands

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Zwolle, , Netherlands

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Singapore, , Singapore

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Badalona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Oviedo, Principality of Asturias, Spain

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Seville, Sevilla, Spain

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Valencia, Valencia, Spain

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Gothenburg, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Kleinriehenstrasse 30, Basel, Switzerland

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Basel, Canton of Basel-City, Switzerland

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Geneva, Canton of Geneva, Switzerland

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Basel, , Switzerland

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Bruderholz, , Switzerland

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Lucerne, , Switzerland

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Rheinstrasse 26, , Switzerland

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Edgbaston, Birmingham, United Kingdom

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Cambridge, Cambridgeshire, United Kingdom

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Withington, Manchester, United Kingdom

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Birmingham, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Countries

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Hong Kong United States Argentina Australia Austria Canada Chile China Denmark Finland France Germany Hungary Italy Netherlands Singapore South Korea Spain Sweden Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 28410911 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27238653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24297950 (View on PubMed)

Related Links

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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

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Other Identifiers

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B1771003

Identifier Type: -

Identifier Source: secondary_id

3066K1-404

Identifier Type: -

Identifier Source: org_study_id