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

NCT00474786 | Completed Phase 3 Results DMC

• 2 other identifiers: 3066K1-404B1771003
• Study Type: interventional
• Target: 512
• Locations: 19 countries
• Sites: 126

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.

Conditions

Renal Cell Carcinoma

Keywords

Metastatic or Advanced Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (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.

  Baseline up to 24 Months

Secondary Outcomes (5)

• Progression Free Survival (PFS) by Investigator Assessment

  Baseline up to 24 Months

• Percentage of Participants With Tumor Response

  Baseline up to 24 Months

• Overall Survival (OS)

  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

  Weeks 12, 24, and 36

• Duration of Response (DR)

  Baseline up to 24 Months

Other Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to 24 months

Study Arms (2)

1

EXPERIMENTAL

Drug: Sorafenib

2

EXPERIMENTAL

Drug: temsirolimus (Torisel)

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).

1

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (128)

Pfizer Investigational Site

Duarte, California, 91010, United States

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La Jolla, California, 92037, United States

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La Jolla, California, 92093, United States

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Los Angeles, California, 90095-6984, United States

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Los Angeles, California, 90095, United States

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Orange, California, 92868, United States

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Riverside, California, 92505, United States

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San Diego, California, 92103, United States

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Meriden, Connecticut, 06451, United States

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Municie, Indiana, 47303, United States

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Louisville, Kentucky, 40202, United States

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Metairie, Louisiana, 70006, United States

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Baltimore, Maryland, 21201, United States

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Bethesda, Maryland, 20817, United States

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Tupelo, Mississippi, 38801, United States

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New York, New York, 10065, United States

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Cleveland, Ohio, 44195, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74104, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75226, United States

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Dallas, Texas, 75246, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84112-5550, United States

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Salt Lake City, Utah, 84412, United States

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Seattle, Washington, 98101, United States

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Buenos Aires, Buenos Aires, C1426ANZ, Argentina

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Rosario, Santa Fe Province, S2000KZE, Argentina

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Buenos Aires, C1122AAL, Argentina

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Buenos Aires, C1437JCP, Argentina

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Nueva Cordoba, X5006HBF, Argentina

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San Miguel de Tucumán, T4000 IAK, Argentina

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Kogarah, New South Wales, 2217, Australia

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St Leonards, New South Wales, 2065, Australia

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Westmead, New South Wales, 2145, Australia

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South Brisbane, Queensland, 4101, Australia

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Adelaide, South Australia, 5000, Australia

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Elizabeth Vale, South Australia, 5112, Australia

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Woodville South, South Australia, 5011, Australia

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Vienna, Austria, 1090, Austria

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Salzburg, 5020, Austria

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Edmonton, Alberta, T6G 1Z2, Canada

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Kelowna, British Columbia, V1Y 5L3, Canada

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Vancouver, British Columbia, V5Z 4E6, Canada

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Victoria, British Columbia, V8R 6V5, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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Cornwall, Ontario, K6R 5S5, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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London, Ontario, N6A 4G5, Canada

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London, Ontario, N6A 4L6, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Ottawa, Ontario, K1Y 4K7, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Providencia, Santiago Metropolitan, Chile

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Hong Kong, China

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Aarhus C, 8000, Denmark

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Herlev, 2730, Denmark

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Tampere, 33 521, Finland

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Turku, 20 520, Finland

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Montpellier, Cedex 5, 34298, France

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Angers, 49100, France

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Besançon, 25000, France

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Bordeaux, 33075, France

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Caen, 14076, France

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Clermont-Ferrand, 63011, France

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Dijon, 21079, France

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Lille, 59000, France

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Lyon, 69373, France

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Marseille, 13273, France

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Paris, 75908, France

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Poitiers, 86021, France

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Saint Herlain/Nantes Cedex, 44805, France

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Strasbourg, 67091, France

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Vandœuvre-lès-Nancy, 54511, France

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Villejuif, 94805, France

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Berlin, 10117, Germany

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Dresden, 01307, Germany

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Heidelberg, 69120, Germany

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Kassel, 34125, Germany

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Lübeck, 23538, Germany

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München, 81675, Germany

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Neuss, 41464, Germany

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Ulm, 89081, Germany

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Budapest, H-1122, Hungary

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Chieti, 66013, Italy

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Florence, 50134, Italy

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Napoli, 80131, Italy

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Pavia, 27100, Italy

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Roma, 00144, Italy

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Roma, 00152, Italy

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Roma, 0144, Italy

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Dordrecht, 3318 AT, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Zwolle, 8025 AB, Netherlands

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Singapore, 169610, Singapore

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Badalona, Barcelona, 08916, Spain

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Barcelona, Barcelona, 08025, Spain

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Sabadell, Barcelona, 08208, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28041, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Seville, Sevilla, 41013, Spain

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Valencia, Valencia, 46010, Spain

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Gothenburg, SE-413 45, Sweden

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Lund, 221 85, Sweden

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Malmo, 205 02, Sweden

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Kleinriehenstrasse 30, Basel, Switzerland

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Basel, Canton of Basel-City, 4031, Switzerland

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Geneva, Canton of Geneva, 1221, Switzerland

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Basel, Switzerland

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Bruderholz, Switzerland

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Lucerne, 6000, Switzerland

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Rheinstrasse 26, Switzerland

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Edgbaston, Birmingham, B5 7UG, United Kingdom

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Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

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Withington, Manchester, M20 4BX, United Kingdom

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Birmingham, B15 2TH, United Kingdom

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London, SE1 9RT, United Kingdom

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Manchester, M23 9LT, United Kingdom

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Newcastle upon Tyne, NE4 6BE, United Kingdom

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Related Publications (3)

• 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.

  PMID: 28410911 DERIVED

• 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.

  PMID: 27238653 DERIVED

• 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.

  PMID: 24297950 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Sorafenib; temsirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: May 17, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: November 21, 2013
• Results First Posted: March 7, 2013

Record last verified: 2013-10

Locations

KR (4); GB (7); CN (1); NL (3); US (26); AU (7); DK (2); DE (8); CL (1); CH (7); CA (16); HU (1); IT (7); FI (2); ES (8); SE (3); SG (1); FR (16); AR (6)