--- title: Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib nct_id: NCT00474786 overall_status: COMPLETED phase: PHASE3 sponsor: Pfizer study_type: INTERVENTIONAL primary_condition: Renal Cell Carcinoma countries: United States, Argentina, Australia, Austria, Canada, Chile, China, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Singapore, South Korea, Spain, Sweden, Switzerland, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00474786.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00474786" ct_last_update_post_date: 2013-11-21 last_seen_at: "2026-05-12T06:18:35.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib **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 **NCT ID:** [NCT00474786](https://clinicaltrials.gov/study/NCT00474786) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 512 - **Lead Sponsor:** Pfizer - **Conditions:** Renal Cell Carcinoma - **Start Date:** 2007-09 - **Completion Date:** 2013-01 - **CT.gov Last Update:** 2013-11-21 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **1** (EXPERIMENTAL) - **2** (EXPERIMENTAL) ## Interventions - **Sorafenib** (DRUG) — 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. ## Primary Outcomes - **Progression-Free Survival (PFS)** _(time frame: Baseline up to 24 Months)_ — 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. ## Secondary Outcomes - **Progression Free Survival (PFS) by Investigator Assessment** _(time frame: Baseline up to 24 Months)_ - **Percentage of Participants With Tumor Response** _(time frame: Baseline up to 24 Months)_ - **Overall Survival (OS)** _(time frame: Baseline to date of death from any cause (up to 24 months))_ - **Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment** _(time frame: Weeks 12, 24, and 36)_ - **Duration of Response (DR)** _(time frame: Baseline up to 24 Months)_ ## Locations (128) - Pfizer Investigational Site, Duarte, California, United States - Pfizer Investigational Site, La Jolla, California, United States - Pfizer Investigational Site, La Jolla, California, United States - Pfizer Investigational Site, Los Angeles, California, United States - Pfizer Investigational Site, Los Angeles, California, United States - Pfizer Investigational Site, Orange, California, United States - Pfizer Investigational Site, Riverside, California, United States - Pfizer Investigational Site, San Diego, California, United States - Pfizer Investigational Site, Meriden, Connecticut, United States - Pfizer Investigational Site, Municie, Indiana, United States - Pfizer Investigational Site, Louisville, Kentucky, United States - Pfizer Investigational Site, Metairie, Louisiana, United States - Pfizer Investigational Site, Baltimore, Maryland, United States - Pfizer Investigational Site, Bethesda, Maryland, United States - Pfizer Investigational Site, Tupelo, Mississippi, United States - Pfizer Investigational Site, New York, New York, United States - Pfizer Investigational Site, Cleveland, Ohio, United States - Pfizer Investigational Site, Oklahoma City, Oklahoma, United States - Pfizer Investigational Site, Tulsa, Oklahoma, United States - Pfizer Investigational Site, Austin, Texas, United States - Pfizer Investigational Site, Dallas, Texas, United States - Pfizer Investigational Site, Dallas, Texas, United States - Pfizer Investigational Site, San Antonio, Texas, United States - Pfizer Investigational Site, Salt Lake City, Utah, United States - Pfizer Investigational Site, Salt Lake City, Utah, United States - Pfizer Investigational Site, Seattle, Washington, United States - Pfizer Investigational Site, Buenos Aires, Buenos Aires, Argentina - Pfizer Investigational Site, Rosario, Santa Fe Province, Argentina - Pfizer Investigational Site, Buenos Aires, Argentina - Pfizer Investigational Site, Buenos Aires, Argentina - Pfizer Investigational Site, Nueva Cordoba, Argentina - Pfizer Investigational Site, San Miguel de Tucumán, Argentina - Pfizer Investigational Site, Kogarah, New South Wales, Australia - Pfizer Investigational Site, St Leonards, New South Wales, Australia - Pfizer Investigational Site, Westmead, New South Wales, Australia - Pfizer Investigational Site, South Brisbane, Queensland, Australia - Pfizer Investigational Site, Adelaide, South Australia, Australia - Pfizer Investigational Site, Elizabeth Vale, South Australia, Australia - Pfizer Investigational Site, Woodville South, South Australia, Australia - Pfizer Investigational Site, Vienna, Austria, Austria - Pfizer Investigational Site, Salzburg, Austria - Pfizer Investigational Site, Edmonton, Alberta, Canada - Pfizer Investigational Site, Kelowna, British Columbia, Canada - Pfizer Investigational Site, Vancouver, British Columbia, Canada - Pfizer Investigational Site, Victoria, British Columbia, Canada - Pfizer Investigational Site, Halifax, Nova Scotia, Canada - Pfizer Investigational Site, Halifax, Nova Scotia, Canada - Pfizer Investigational Site, Halifax, Nova Scotia, Canada - Pfizer Investigational Site, Cornwall, Ontario, Canada - Pfizer Investigational Site, Hamilton, Ontario, Canada - Pfizer Investigational Site, London, Ontario, Canada - Pfizer Investigational Site, London, Ontario, Canada - Pfizer Investigational Site, Ottawa, Ontario, Canada - Pfizer Investigational Site, Ottawa, Ontario, Canada - Pfizer Investigational Site, Toronto, Ontario, Canada - Pfizer Investigational Site, Toronto, Ontario, Canada - Pfizer Investigational Site, Montreal, Quebec, Canada - Pfizer Investigational Site, Providencia, Santiago Metropolitan, Chile - Pfizer Investigational Site, Hong Kong, China - Pfizer Investigational Site, Aarhus C, Denmark - Pfizer Investigational Site, Herlev, Denmark - Pfizer Investigational Site, Tampere, Finland - Pfizer Investigational Site, Turku, Finland - Pfizer Investigational Site, Montpellier, Cedex 5, France - Pfizer Investigational Site, Angers, France - Pfizer Investigational Site, Besançon, France - Pfizer Investigational Site, Bordeaux, France - Pfizer Investigational Site, Caen, France - Pfizer Investigational Site, Clermont-Ferrand, France - Pfizer Investigational Site, Dijon, France - Pfizer Investigational Site, Lille, France - Pfizer Investigational Site, Lyon, France - Pfizer Investigational Site, Marseille, France - Pfizer Investigational Site, Paris, France - Pfizer Investigational Site, Poitiers, France - Pfizer Investigational Site, Saint Herlain/Nantes Cedex, France - Pfizer Investigational Site, Strasbourg, France - Pfizer Investigational Site, Vandœuvre-lès-Nancy, France - Pfizer Investigational Site, Villejuif, France - Pfizer Investigational Site, Berlin, Germany - Pfizer Investigational Site, Dresden, Germany - Pfizer Investigational Site, Heidelberg, Germany - Pfizer Investigational Site, Kassel, Germany - Pfizer Investigational Site, Lübeck, Germany - Pfizer Investigational Site, München, Germany - Pfizer Investigational Site, Neuss, Germany - Pfizer Investigational Site, Ulm, Germany - Pfizer Investigational Site, Budapest, Hungary - Pfizer Investigational Site, Chieti, Italy - Pfizer Investigational Site, Florence, Italy - Pfizer Investigational Site, Naples, Italy - Pfizer Investigational Site, Pavia, Italy - Pfizer Investigational Site, Roma, Italy - Pfizer Investigational Site, Roma, Italy - Pfizer Investigational Site, Roma, Italy - Pfizer Investigational Site, Dordrecht, Netherlands - Pfizer Investigational Site, Leeuwarden, Netherlands - Pfizer Investigational Site, Zwolle, Netherlands - Pfizer Investigational Site, Singapore, Singapore - Pfizer Investigational Site, Seoul, South Korea - Pfizer Investigational Site, Seoul, South Korea - Pfizer Investigational Site, Seoul, South Korea - Pfizer Investigational Site, Seoul, South Korea - Pfizer Investigational Site, Badalona, Barcelona, Spain - Pfizer Investigational Site, Barcelona, Barcelona, Spain - Pfizer Investigational Site, Sabadell, Barcelona, Spain - Pfizer Investigational Site, Madrid, Madrid, Spain - Pfizer Investigational Site, Madrid, Madrid, Spain - Pfizer Investigational Site, Oviedo, Principality of Asturias, Spain - Pfizer Investigational Site, Seville, Sevilla, Spain - Pfizer Investigational Site, Valencia, Valencia, Spain - Pfizer Investigational Site, Gothenburg, Sweden - Pfizer Investigational Site, Lund, Sweden - Pfizer Investigational Site, Malmö, Sweden - Pfizer Investigational Site, Kleinriehenstrasse 30, Basel, Switzerland - Pfizer Investigational Site, Basel, Canton of Basel-City, Switzerland - Pfizer Investigational Site, Geneva, Canton of Geneva, Switzerland - Pfizer Investigational Site, Basel, Switzerland - Pfizer Investigational Site, Bruderholz, Switzerland - Pfizer Investigational Site, Lucerne, Switzerland - Pfizer Investigational Site, Rheinstrasse 26, Switzerland - Pfizer Investigational Site, Edgbaston, Birmingham, United Kingdom - Pfizer Investigational Site, Cambridge, Cambridgeshire, United Kingdom - Pfizer Investigational Site, Withington, Manchester, United Kingdom - Pfizer Investigational Site, Birmingham, United Kingdom - Pfizer Investigational Site, London, United Kingdom - Pfizer Investigational Site, Manchester, United Kingdom - Pfizer Investigational Site, Newcastle upon Tyne, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.pfizer investigational site|duarte|california|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|la jolla|california|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|los angeles|california|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|orange|california|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|riverside|california|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|san diego|california|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|meriden|connecticut|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|municie|indiana|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|metairie|louisiana|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|bethesda|maryland|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|tupelo|mississippi|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|new york|new york|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|tulsa|oklahoma|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|austin|texas|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|dallas|texas|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|salt lake city|utah|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|seattle|washington|united states` — added _(2026-05-12)_ - `locations.pfizer investigational site|buenos aires|buenos aires|argentina` — added _(2026-05-12)_ - `locations.pfizer investigational site|rosario|santa fe province|argentina` — added _(2026-05-12)_ - `locations.pfizer investigational site|buenos aires||argentina` — added _(2026-05-12)_ - `locations.pfizer investigational site|nueva cordoba||argentina` — added _(2026-05-12)_ - `locations.pfizer investigational site|san miguel de tucumán||argentina` — added _(2026-05-12)_ - `locations.pfizer investigational site|kogarah|new south wales|australia` — added _(2026-05-12)_ - `locations.pfizer investigational site|st leonards|new south wales|australia` — added _(2026-05-12)_ - `locations.pfizer investigational site|westmead|new south wales|australia` — added _(2026-05-12)_ - `locations.pfizer investigational site|south brisbane|queensland|australia` — added _(2026-05-12)_ - `locations.pfizer investigational site|adelaide|south australia|australia` — added _(2026-05-12)_ - `locations.pfizer investigational site|elizabeth vale|south australia|australia` — added _(2026-05-12)_ - `locations.pfizer investigational site|woodville south|south australia|australia` — added _(2026-05-12)_ - `locations.pfizer investigational site|vienna|austria|austria` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00474786.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00474786* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*