Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

NCT01223027 | Completed Phase 3 Results DMC

• 2 other identifiers: CTKI258A23022009-015459-25
• Study Type: interventional
• Target: 564
• Locations: 26 countries
• Sites: 193

Brief Summary

This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Dovitinib; TKI; Renal cell cancer; RCC; mRCC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Per Independent Central Radiology Review

  Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.

  Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)

Secondary Outcomes (8)

• Overall Survival (OS)

  until at least 386 deaths are documented in the clinical database.

• Progression Free Survival (PFS) Per Investigator's Radiology Review

  Until disease progression or discontinuation of treatment due to unacceptable toxicity

• Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review

  Until disease progression or discontinuation of treatment due to unacceptable toxicity

• Time to Definitive Worsening of Karnofsky Performance Status (KPS)

  from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier

• Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores

  from date of randomization, at least 2 score units

Study Arms (2)

Dovitinib + best supportive care (BSC)

EXPERIMENTAL

Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule.

Drug: Dovitinib

Sorafenib + BSC

ACTIVE COMPARATOR

Patients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily.

Drug: Sorafenib

Interventions

Dovitinib DRUG

Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language.

Also known as: TKI258

Dovitinib + best supportive care (BSC)

Sorafenib DRUG

Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.

Sorafenib + BSC

Eligibility Criteria

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

You may qualify if:

• Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell
• Patients must have received one and only one prior VEGF-targeted therapy and one and only one prior mTOR inhibitor therapy in the metastatic setting. One VEGF targeted therapy (e.g. sunitinib, or pazopanib, or axitinib, or tivozanib or bevacizumab) and one prior mTOR inhibitor therapy (everolimus, or temsirolimus or ridaforolimus)
• Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted.
• Patients must have had disease progression on or within 6 months of stopping the last therapy.
• Patients must have at least one measurable lesion at baseline (by RECIST Criteria Guidelines v1.1) assessed by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).
• Karnofsky performance status ≥ 70%
• Patients must have the following laboratory values:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
• Platelets ≥ 100 x 109/L
• Hemoglobin (Hgb) \> 9 g/dL
• Serum total bilirubin: ≤ 1.5 x ULN
• ALT and AST ≤ 3.0 x ULN (Patients with known liver metastases: AST and ALT ≤ 5.0 x ULN)
• Serum creatinine ≤ 1.5 x ULN

You may not qualify if:

• Patients who have previously received sorafenib therapy in the neoadjuvant, adjuvant or metastatic setting.
• Patients who have previously received Dovitinib or brivanib in the neoadjuvant, adjuvant or metastatic setting.
• Patients with brain metastases. Radiological imaging (e.g. CT or MRI scan) of the brain is required at screening/baseline
• Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix
• Patients who have received the last administration of an anticancer targeted small molecule therapy ≤ 2 weeks prior to starting study treatment (e.g. sunitinib, pazopanib, axitinib, everolimus, temsirolimus), or who have not recovered from the side effects of such therapy
• Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study treatment, or who have not recovered from the side effects of such therapy
• Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy
• Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months
• Patients with concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (199)

Highlands Oncology Group Dept of Highlands Oncology Grp

Fayetteville, Arkansas, 72703, United States

Location

University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)

La Jolla, California, 92093-0658, United States

Location

Cedars Sinai Medical Center Cedars Sinai Medical Ctr. (SC)

Los Angeles, California, 90048, United States

Location

University of California at Los Angeles UCLA (4)

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center Cancer Clinical Trials Office

Stanford, California, 94304, United States

Location

Rocky Mountain Cancer Centers RMCC

Greenwood Village, Colorado, United States

Location

Florida Cancer Specialists DeptofFloridaCancerSpecialists

Fort Myers, Florida, 33901, United States

Location

University Cancer & Blood Center, LLC

Athens, Georgia, 30607, United States

Location

Straub Clinic & Hospital Straub

Honolulu, Hawaii, 96813, United States

Location

Moanalua Medical Center. Attn: Oncology Dept

Honolulu, Hawaii, 96817, United States

Location

University of Kansas Cancer Center Univ of KS

Kansas City, Kansas, 66160, United States

Location

University of Maryland Medical Center UMMC

Baltimore, Maryland, 21201, United States

Location

Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)

Detroit, Michigan, 48201, United States

Location

University of Minnesota Medical Center - Fairview Univ of MN

Minneapolis, Minnesota, 55455, United States

Location

Comprehensive Cancer Centers of Nevada CCC of Nevada (1)

Las Vegas, Nevada, 89109, United States

Location

CINJ at Cooper University Hospital Cooper

Voorhees Township, New Jersey, 08043, United States

Location

Memorial Sloan Kettering Cancer Center Dept. of MSKCC

New York, New York, 90033, United States

Location

SUNY - Upstate Medical University Div. of Hematology-Oncology

Syracuse, New York, 13210, United States

Location

New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

Troy, New York, 12180, United States

Location

Willamette Valley Clinical Studies Williamette Valley Cancer

Eugene, Oregon, 97404, United States

Location

St. Luke's Hospital and Health Network St Luke's

Bethlehem, Pennsylvania, United States

Location

Medical University of South Carolina -Hollings Cancer Center Med Univ SC

Charleston, South Carolina, 29425, United States

Location

Cancer Centers of the Carolinas CC of C -Eastside

Greenville, South Carolina, 29605, United States

Location

Sarah Cannon Research Institute SC - 3

Chattanooga, Tennessee, 37404, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Vanderbilt University Medical Center SC

Nashville, Tennessee, 37232, United States

Location

Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (4)

Dallas, Texas, 75246, United States

Location

Texas Oncology Texas Onc - Austin

Dallas, Texas, 75251, United States

Location

Texas Oncology Texas Oncology - Houston

Dallas, Texas, 75251, United States

Location

University of Texas Southwestern Medical Center UTSW

Dallas, Texas, 75390-9034, United States

Location

Deke Slayton Cancer Center Deke Slayton Cancer Center (2)

Webster, Texas, 77598, United States

Location

Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

Salt Lake City, Utah, 84106, United States

Location

University of Virginia Health Systems Univ Virginia

Charlottesville, Virginia, 22908-0334, United States

Location

Rockwood Clinic Spokane Location

Spokane, Washington, 99202, United States

Location

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1050AAK, Argentina

Location

Novartis Investigative Site

Rosario, Sante Fe, S200DSK, Argentina

Location

Novartis Investigative Site

St Leonards, New South Wales, 2065, Australia

Location

Novartis Investigative Site

Westmead, New South Wales, 2145, Australia

Location

Novartis Investigative Site

South Brisbane, Queensland, 4101, Australia

Location

Novartis Investigative Site

Woodville, South Australia, 5011, Australia

Location

Novartis Investigative Site

Footscray, Victoria, 3011, Australia

Location

Novartis Investigative Site

Heidelberg, Victoria, 3084, Australia

Location

Novartis Investigative Site

Linz, A-4020, Austria

Location

Novartis Investigative Site

Vienna, 1090, Austria

Location

Novartis Investigative Site

Brussels, 1000, Belgium

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Novartis Investigative Site

Calgary, Alberta, T2N 4N2, Canada

Location

Novartis Investigative Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Novartis Investigative Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Novartis Investigative Site

Hamilton, Ontario, L8N 4A6, Canada

Location

Novartis Investigative Site

London, Ontario, N6A 4L6, Canada

Location

Novartis Investigative Site

Ottawa, Ontario, K1H 8L6, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M4N 3M5, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H2L 4M1, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H2X 1N8, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3T 1E2, Canada

Location

Novartis Investigative Site

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Novartis Investigative Site

Bogotá, Colombia

Location

Novartis Investigative Site

Brno, Czech Republic, 656 53, Czechia

Location

Novartis Investigative Site

Olomouc, 775 20, Czechia

Location

Novartis Investigative Site

Prague, 150 06, Czechia

Location

Novartis Investigative Site

Suresnes, France, 92150, France

Location

Novartis Investigative Site

Besançon, 25030, France

Location

Novartis Investigative Site

Bordeaux, 33075, France

Location

Novartis Investigative Site

Caen, 14021, France

Location

Novartis Investigative Site

Clermont-Ferrand, 63011, France

Location

Novartis Investigative Site

Grenoble, 38043, France

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Marseille, 13273, France

Location

Novartis Investigative Site

Nice, 06189, France

Location

Novartis Investigative Site

Paris, 75015, France

Location

Novartis Investigative Site

Paris, 75651, France

Location

Novartis Investigative Site

Rennes, 35062, France

Location

Novartis Investigative Site

Saint-Herblain Cédex, 44805, France

Location

Novartis Investigative Site

Saint-Priest-en-Jarez, 42271, France

Location

Novartis Investigative Site

Strasbourg, F-67098, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Vandoeuvre-Les-Nancy Cede, 54511, France

Location

Novartis Investigative Site

Villejuif, 94805, France

Location

Novartis Investigative Site

Aschaffenburg, 63739, Germany

Location

Novartis Investigative Site

Berlin, 10098, Germany

Location

Novartis Investigative Site

Chemnitz, 09119, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Greifswald, 17475, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Jena, 07740, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Marburg, 35039, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Nuremberg, 90419, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Weiden, 92637, Germany

Location

Novartis Investigative Site

Athens, Greece, 115 28, Greece

Location

Novartis Investigative Site

Athens, GR, 115 27, Greece

Location

Novartis Investigative Site

Thessaloniki, GR, 546 45, Greece

Location

Novartis Investigative Site

Budapest, 1086, Hungary

Location

Novartis Investigative Site

Budapest, H-1122, Hungary

Location

Novartis Investigative Site

Debrecen, 4032, Hungary

Location

Novartis Investigative Site

Pécs, 7624, Hungary

Location

Novartis Investigative Site

Szolnok, H-5000, Hungary

Location

Novartis Investigative Site

Petah Tikva, 49100, Israel

Location

Novartis Investigative Site

Ramat Gan, 5266202, Israel

Location

Novartis Investigative Site

Zrifin, 70300, Israel

Location

Novartis Investigative Site

Arezzo, AR, 52100, Italy

Location

Novartis Investigative Site

Cremona, CR, 26100, Italy

Location

Novartis Investigative Site

Meldola, FC, 47014, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Modena, MO, 41100, Italy

Location

Novartis Investigative Site

Pavia, PV, 27100, Italy

Location

Novartis Investigative Site

Roma, RM, 00152, Italy

Location

Novartis Investigative Site

Candiolo, TO, 10060, Italy

Location

Novartis Investigative Site

Napoli, 80132, Italy

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 466-8560, Japan

Location

Novartis Investigative Site

Chiba, Chiba, 260-8717, Japan

Location

Novartis Investigative Site

Tōon, Ehime, 791-0295, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Novartis Investigative Site

Hiroshima, Hiroshima, 734-8551, Japan

Location

Novartis Investigative Site

Obihiro, Hokkaido, 080-0016, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0047, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 236 0037, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 241-8515, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 602-8566, Japan

Location

Novartis Investigative Site

Matsumoto, Nagano, 390-8621, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 537-8511, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 545-8586, Japan

Location

Novartis Investigative Site

Sayama, Osaka, 589-8511, Japan

Location

Novartis Investigative Site

Suita, Osaka, 565-0871, Japan

Location

Novartis Investigative Site

Takatsuki, Osaka, 569-8686, Japan

Location

Novartis Investigative Site

Hidaka, Saitama, 350-1298, Japan

Location

Novartis Investigative Site

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Novartis Investigative Site

Koto, Tokyo, 135-8550, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 105-8470, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Novartis Investigative Site

Yamagata, Yamagata, 990-9585, Japan

Location

Novartis Investigative Site

Meerssen, KR, 6231, Netherlands

Location

Novartis Investigative Site

Amsterdam, 1081 HV, Netherlands

Location

Novartis Investigative Site

Breda, 4818 CK, Netherlands

Location

Novartis Investigative Site

Dordrecht, 3318AT, Netherlands

Location

Novartis Investigative Site

Maastricht, 6229 HX, Netherlands

Location

Novartis Investigative Site

Rotterdam, 3075 EA, Netherlands

Location

Novartis Investigative Site

Ålesund, NO-6026, Norway

Location

Novartis Investigative Site

Bergen, -N5021, Norway

Location

Novartis Investigative Site

Warsaw, 02-781, Poland

Location

Novartis Investigative Site

Warsaw, 04-141, Poland

Location

Novartis Investigative Site

Riyadh, 11211, Saudi Arabia

Location

Novartis Investigative Site

Bratislava, Slovak Republic, 83310, Slovakia

Location

Novartis Investigative Site

Seoul, Korea, 03722, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 06351, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 110 744, South Korea

Location

Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

Location

Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

Location

Novartis Investigative Site

Seville, Andalusia, 41014, Spain

Location

Novartis Investigative Site

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Novartis Investigative Site

Barcelona, Barcelona, 08041, Spain

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Badalona, Catalonia, 08916, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Novartis Investigative Site

Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, 35016, Spain

Location

Novartis Investigative Site

Alcorcón, Madrid, 28922, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28007, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28040, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28041, Spain

Location

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

Location

Novartis Investigative Site

Oviedo, Principality of Asturias, 33006, Spain

Location

Novartis Investigative Site

Benidorm, Valencia, 03501, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46009, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46010, Spain

Location

Novartis Investigative Site

Stockholm, SE-171 76, Sweden

Location

Novartis Investigative Site

Sundsvall, 851 86, Sweden

Location

Novartis Investigative Site

Umeå, SE-901 85, Sweden

Location

Novartis Investigative Site

Uppsala, SE-751 85, Sweden

Location

Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

Location

Novartis Investigative Site

Bangkok, 10700, Thailand

Location

Novartis Investigative Site

Bristol, Avon, BS2 8ED, United Kingdom

Location

Novartis Investigative Site

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Novartis Investigative Site

Colchester, CO3 3NB, United Kingdom

Location

Novartis Investigative Site

Leicester, LE1 5WW, United Kingdom

Location

Novartis Investigative Site

London, NW3 4QG, United Kingdom

Location

Novartis Investigative Site

London, SW17 0QT, United Kingdom

Location

Novartis Investigative Site

Manchester, M20 9BX, United Kingdom

Location

Novartis Investigative Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grunwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Mar;15(3):286-96. doi: 10.1016/S1470-2045(14)70030-0. Epub 2014 Feb 17.

  PMID: 24556040 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one; Sorafenib

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

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: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registry@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 18, 2010
• Study Start: March 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 7, 2015
• Results First Posted: November 6, 2015

Record last verified: 2015-11

Locations

PL (2); JP (26); AU (2); SA (1); NO (2); CZ (3); DE (16); GR (3); AR (2); CA (13); CO (1); US (34); HU (5); FR (18); NL (6); BR (1); IL (3); ES (22); CH (1); SL (1); BE (5); SE (4); TH (1); GB (8); KR (4); IT (9)