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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01223027
First received: September 30, 2010
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Dovitinib
Drug: Sorafenib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To compare Progression Free Survival (PFS) in Dovitinib and Sorafenib Groups (central radiology assessment) [ Time Frame: Until disease progression or discontinuation of treatment due to unacceptable toxicity ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare Overall Survival (OS) in Dovitinib and Sorafenib Groups [ Time Frame: until at least 386 deaths are documented in the clinical database. ] [ Designated as safety issue: No ]
  • To compare Progression Free Survival (PFS) in Dovitinib and Sorafenib Groups (investigator assessed) [ Time Frame: Until disease progression or discontinuation of treatment due to unacceptable toxicity ] [ Designated as safety issue: No ]
  • Overall response rate (ORR) by central and local radiology [ Time Frame: Until disease progression or discontinuation of treatment due to unacceptable toxicity ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs, ECGs and laboratory results (hematology, blood chemistry, urinalysis, thyroid function tests, lipid profile, cardiac enzimes and coagulation tests). [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • To assess patient-reported outcomes (PROs), including disease-related symptoms using the FKSI-DRS questionnaire and Quality of Life using the EORTC QLQ-C30 questionnaire [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • To assess the Dovitinib concentration in plasma in relation to cardiac safety [ Time Frame: Week 2 Day 5, Week 4 Day 5 ] [ Designated as safety issue: No ]

Enrollment: 564
Study Start Date: March 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dovitinib + best supportive care (BSC) Drug: Dovitinib
Other Name: TKI258
Active Comparator: Sorafenib + BSC Drug: Sorafenib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell
  3. 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)
  4. Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted.
  5. Patients must have had disease progression on or within 6 months of stopping the last therapy.
  6. 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).
  7. Karnofsky performance status ≥ 70%
  8. 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

Exclusion Criteria:

  1. Patients who have previously received sorafenib therapy in the neoadjuvant, adjuvant or metastatic setting.
  2. Patients who have previously received Dovitinib or brivanib in the neoadjuvant, adjuvant or metastatic setting.
  3. Patients with brain metastases. Radiological imaging (e.g. CT or MRI scan) of the brain is required at screening/baseline
  4. 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
  5. 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
  6. 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
  7. 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
  8. Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months
  9. Patients with concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223027

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Locations
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
United States, California
University of California San Diego Dept of Moores Cancer Ctr (5)
La Jolla, California, United States, 92093-0658
Cedars Sinai Medical Center Cedars Sinai Medical Ctr. (SC)
Los Angeles, California, United States, 90048
University of California at Los Angeles UCLA (4)
Los Angeles, California, United States, 90095
Stanford University Medical Center Cancer Clinical Trials Office
Stanford, California, United States, 94304
United States, Colorado
Rocky Mountain Cancer Centers RMCC
Greenwood Village, Colorado, United States
United States, Florida
Florida Cancer Specialists DeptofFloridaCancerSpecialists
Fort Myers, Florida, United States, 33901
United States, Georgia
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607
United States, Hawaii
Kaiser Permanente Hawaii
Honolulu, Hawaii, United States, 96817
Straub Clinic & Hospital Straub
Honolulu, Hawaii, United States, 96813
United States, Kansas
University of Kansas Cancer Center Univ of KS
Kansas City, Kansas, United States, 66160
United States, Maryland
University of Maryland Medical Center UMMC
Baltimore, Maryland, United States, 21201
United States, Michigan
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota Medical Center - Fairview Univ of MN
Minneapolis, Minnesota, United States, 55455
United States, Nevada
Comprehensive Cancer Centers of Nevada CCC of Nevada (1)
Las Vegas, Nevada, United States, 89109
United States, New Jersey
CINJ at Cooper University Hospital Cooper
Voorhees, New Jersey, United States, 08043
United States, New York
Memorial Sloan Kettering Cancer Center Dept. of MSKCC
New York, New York, United States, 10021
SUNY - Upstate Medical University Div. of Hematology-Oncology
Syracuse, New York, United States, 13210
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
Troy, New York, United States, 12180
United States, Oregon
Willamette Valley Clinical Studies Williamette Valley Cancer
Eugene, Oregon, United States, 97404
United States, Pennsylvania
St. Luke's Hospital and Health Network St Luke's
Bethlehem, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina -Hollings Cancer Center Med Univ SC
Charleston, South Carolina, United States, 29425
Cancer Centers of the Carolinas CC of C -Eastside
Greenville, South Carolina, United States, 29605
United States, Tennessee
Sarah Cannon Research Institute SC - 3
Chattanooga, Tennessee, United States, 37404
The West Clinic
Memphis, Tennessee, United States, 38120
Vanderbilt University Medical Center SC
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology, P.A. Texas Oncology - Houston
Dallas, Texas, United States, 75251
Texas Oncology, P.A. Texas Onc - Austin
Dallas, Texas, United States, 75251
Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (4)
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center UTSW
Dallas, Texas, United States, 75390-9034
Deke Slayton Cancer Center c/o Study Coordinator
Webster, Texas, United States, 77598
United States, Utah
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
Salt Lake City, Utah, United States, 84106
United States, Virginia
University of Virginia Health Systems Univ Virginia
Charlottesville, Virginia, United States, 22908-0334
United States, Washington
Rockwood Clinic Spokane Location
Spokane, Washington, United States, 99202
Argentina
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Rosario, Sante Fe, Argentina, S200DSK
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Buenos Aires, Argentina, C1050AAK
Australia, New South Wales
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St. Leonards, New South Wales, Australia, 2065
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Westmead, New South Wales, Australia, 2145
Australia, Queensland
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South Brisbane, Queensland, Australia, 4101
Australia, South Australia
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Woodville, South Australia, Australia, 5011
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Footscray, Victoria, Australia, 3011
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Heidelberg, Victoria, Australia, 3084
Austria
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Linz, Austria, A-4020
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Wien, Austria, 1090
Belgium
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Bruxelles, Belgium, 1000
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Bruxelles, Belgium, 1200
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
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Porto Alegre, RS, Brazil, 90610-000
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Saskatoon, Saskatchewan, Canada, S7N 4H4
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Bogotá, Colombia
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Brno, Czech Republic, 656 53
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Olomouc, Czech Republic, 775 20
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Praha 5, Czech Republic, 150 06
France
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Besancon Cedex, France, 25030
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Bordeaux Cedex, France, 33075
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Caen Cedex, France, 14021
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Clermont-Ferrand, France, 63011
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Grenoble, France, 38043
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Lyon Cedex, France, 69373
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Marseille, France, 13273
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Nice Cedex 2, France, 06189
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Paris, France, 75015
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Paris Cedex 13, France, 75651
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Rennes Cedex, France, 35062
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Saint Priest en Jarez Cedex, France, 42271
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Saint-Herblain Cédex, France, 44805
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Strasbourg Cedex, France, F-67098
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Suresnes, France, 92150
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Toulouse Cedex 3, France, 31052
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Vandoeuvre-Les-Nancy Cede, France, 54511
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Villejuif Cedex, France, 94805
Germany
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Aschaffenburg, Germany, 63739
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Berlin, Germany, 10098
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Chemnitz, Germany, 09119
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Erlangen, Germany, 91054
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Greifswald, Germany, 17475
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Hamburg, Germany, 20246
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Hannover, Germany, 30625
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Heidelberg, Germany, 69120
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Jena, Germany, 07740
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Leipzig, Germany, 04103
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Marburg, Germany, 35039
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Muenster, Germany, 48149
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München, Germany, 81675
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Nuernberg, Germany, 90419
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Ulm, Germany, 89081
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Weiden, Germany, 92637
Greece
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Athens, GR, Greece, 115 27
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Athens, Greece, 115 28
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Thessaloniki, Greece, 54645
Hungary
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Budapest, Hungary, H-1122
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Budapest, Hungary, 1086
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Debrecen, Hungary, 4032
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Pecs, Hungary, 7624
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Szolnok, Hungary, H-5000
Israel
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Petach Tikva, Israel, 49100
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Ramat Gan, Israel, 52621
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Zrifin, Israel, 70300
Italy
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Arezzo, AR, Italy, 52100
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Cremona, CR, Italy, 26100
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Meldola, FC, Italy, 47014
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Milano, MI, Italy, 20133
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Modena, MO, Italy, 41100
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Pavia, PV, Italy, 27100
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Roma, RM, Italy, 00152
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Candiolo, TO, Italy, 10060
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Napoli, Italy, 80132
Japan
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Nagoya-city, Aichi, Japan, 466-8560
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Toon-city, Ehime, Japan, 791-0295
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Fukuoka-city, Fukuoka, Japan, 812-8582
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Obihiro, Hokkaido, Japan, 080-0016
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Sapporo-city, Hokkaido, Japan, 060-8648
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Kobe-city, Hyogo, Japan, 650-0047
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Kobe-city, Hyogo, Japan, 650-0017
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Yokohama, Kanagawa, Japan, 241-8515
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Yokohama-city, Kanagawa, Japan, 236 0037
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Matsumoto, Nagano, Japan, 390-8621
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Osaka-city, Osaka, Japan, 545-8586
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OsakaSayama, Osaka, Japan, 589-8511
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Suita-city, Osaka, Japan, 565-0871
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Takatsuki, Osaka, Japan, 569-8686
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Hidaka, Saitama, Japan, 350-1298
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Kitaadachi-gun, Saitama, Japan, 362-0806
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Bunkyo-ku, Tokyo, Japan, 113-8603
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Koto, Tokyo, Japan, 135-8550
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Minato-ku, Tokyo, Japan, 105-8470
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Shinjuku-ku, Tokyo, Japan, 160-8582
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Shinjuku-ku, Tokyo, Japan, 162-8666
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Chiba, Japan, 260-8717
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Hiroshima, Japan, 734-8551
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Kyoto, Japan, 602-8566
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Osaka, Japan, 537-8511
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Yamagata, Japan, 990-9585
Korea, Republic of
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Seoul, Korea, Korea, Republic of, 135-710
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Seoul, Korea, Korea, Republic of, 110 744
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Seoul, Korea, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 738-736
Netherlands
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Meerssen, KR, Netherlands, 6231
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Amsterdam, Netherlands, 1081 HV
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Breda, Netherlands, 4818 CK
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Dordrecht, Netherlands, 3318AT
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Maastricht, Netherlands, 6229 HX
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Rotterdam, Netherlands, 3075 EA
Norway
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Bergen, Norway, -N5021
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Ålesund, Norway, NO-6026
Poland
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Warszawa, Poland, 02-781
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Warszawa, Poland, 00-909
Saudi Arabia
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Riyadh, Saudi Arabia, 11211
Slovakia
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Bratislava, Slovak Republic, Slovakia, 83310
Spain
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Cordoba, Andalucia, Spain, 14004
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Malaga, Andalucia, Spain, 29010
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Sevilla, Andalucia, Spain, 41014
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Oviedo, Asturias, Spain, 33006
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Sabadell, Barcelona, Spain, 08208
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Badalona, Catalunya, Spain, 08916
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Barcelona, Catalunya, Spain, 08036
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Barcelona, Catalunya, Spain, 08035
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Barcelona, Catalunya, Spain, 08003
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Hospitalet de LLobregat, Catalunya, Spain, 08907
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Benidorm, Comunidad Valenciana, Spain, 03501
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Valencia, Comunidad Valenciana, Spain, 46010
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Valencia, Comunidad Valenciana, Spain, 46009
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Santiago de Compostela, Galicia, Spain, 15706
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Palma De Mallorca, Islas Baleares, Spain, 07120
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Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, Spain, 35016
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Alcorcón, Madrid, Spain, 28922
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Pamplona, Navarra, Spain, 31008
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Barcelona, Spain, 08025
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Madrid, Spain, 28009
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Madrid, Spain, 28040
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Madrid, Spain, 28041
Sweden
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Stockholm, Sweden, SE-171 76
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Umeå, Sweden, SE-901 85
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Uppsala, Sweden, SE-751 85
Switzerland
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St. Gallen, Switzerland, 9007
Thailand
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Bangkok, Thailand, 10700
United Kingdom
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Bristol, Avon, United Kingdom, BS2 8ED
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Northwood, Middlesex, United Kingdom, HA6 2RN
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Colchester, United Kingdom, CO3 3NB
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Leicester, United Kingdom, LE1 5WW
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London, United Kingdom, SW17 0QT
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London, United Kingdom, NW3 4QG
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Manchester, United Kingdom, M20 9BX
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Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01223027     History of Changes
Other Study ID Numbers: CTKI258A2302, 2009-015459-25
Study First Received: September 30, 2010
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ministry of Health
Saudi Arabia: Ministry of Health
Brazil: Ministry of Health
Columbia: National Institutes of Health
Argentina: Ministry of Health
Thailand: Food and Drug Administration (KFDA)
south Korea:

Keywords provided by Novartis:
Dovitinib
TKI
Renal cell cancer
RCC
mRCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014