AzTrials
AzTrials

Metastatic Renal Cell CarcinomaPhase 3NCT01223027

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

A Phase 3 study testing Dovitinib and Sorafenib in people with Metastatic Renal Cell Carcinoma, run by Novartis Pharmaceuticals at 199 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Renal Cell Carcinoma
What is being tested?
Dovitinib and Sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
564 participants
Where
199 sitesin 27 countries
Study dates
Mar 2011to Jun 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

199 sites in 27 countries.

199 sites in 27 countries

United States34 sites

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • University of Maryland Medical Center UMMC

    Baltimore, Maryland, 21201

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

    Bethlehem, Pennsylvania

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

    Charleston, South Carolina, 29425

  • University of Virginia Health Systems Univ Virginia

    Charlottesville, Virginia, 22908-0334

  • Sarah Cannon Research Institute SC - 3

    Chattanooga, Tennessee, 37404

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

    Dallas, Texas, 75246

  • Texas Oncology Texas Onc - Austin

    Dallas, Texas, 75251

  • Texas Oncology Texas Oncology - Houston

    Dallas, Texas, 75251

  • University of Texas Southwestern Medical Center UTSW

    Dallas, Texas, 75390-9034

  • Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)

    Detroit, Michigan, 48201

  • Willamette Valley Clinical Studies Williamette Valley Cancer

    Eugene, Oregon, 97404

  • Highlands Oncology Group Dept of Highlands Oncology Grp

    Fayetteville, Arkansas, 72703

  • Florida Cancer Specialists DeptofFloridaCancerSpecialists

    Fort Myers, Florida, 33901

  • Cancer Centers of the Carolinas CC of C -Eastside

    Greenville, South Carolina, 29605

  • Rocky Mountain Cancer Centers RMCC

    Greenwood Village, Colorado

  • Straub Clinic & Hospital Straub

    Honolulu, Hawaii, 96813

  • Moanalua Medical Center. Attn: Oncology Dept

    Honolulu, Hawaii, 96817

  • University of Kansas Cancer Center Univ of KS

    Kansas City, Kansas, 66160

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

    La Jolla, California, 92093-0658

  • Comprehensive Cancer Centers of Nevada CCC of Nevada (1)

    Las Vegas, Nevada, 89109

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

    Los Angeles, California, 90048

  • University of California at Los Angeles UCLA (4)

    Los Angeles, California, 90095

  • The West Clinic

    Memphis, Tennessee, 38120

  • University of Minnesota Medical Center - Fairview Univ of MN

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Medical Center SC

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center Dept. of MSKCC

    New York, New York, 90033

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

    Salt Lake City, Utah, 84106

  • Rockwood Clinic Spokane Location

    Spokane, Washington, 99202

  • Stanford University Medical Center Cancer Clinical Trials Office

    Stanford, California, 94304

  • SUNY - Upstate Medical University Div. of Hematology-Oncology

    Syracuse, New York, 13210

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

    Troy, New York, 12180

  • CINJ at Cooper University Hospital Cooper

    Voorhees Township, New Jersey, 08043

  • Deke Slayton Cancer Center Deke Slayton Cancer Center (2)

    Webster, Texas, 77598

Other trials in United States

Japan26 sites

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8603

  • Novartis Investigative Site

    Chiba, Chiba, 260-8717

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Hidaka, Saitama, 350-1298

  • Novartis Investigative Site

    Hiroshima, Hiroshima, 734-8551

  • Novartis Investigative Site

    Kitaadachi-gun, Saitama, 362-0806

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0017

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0047

  • Novartis Investigative Site

    Koto, Tokyo, 135-8550

  • Novartis Investigative Site

    Kyoto, Kyoto, 602-8566

  • Novartis Investigative Site

    Matsumoto, Nagano, 390-8621

  • Novartis Investigative Site

    Minato-ku, Tokyo, 105-8470

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 466-8560

  • Novartis Investigative Site

    Obihiro, Hokkaido, 080-0016

  • Novartis Investigative Site

    Osaka, Osaka, 537-8511

  • Novartis Investigative Site

    Osaka, Osaka, 545-8586

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648

  • Novartis Investigative Site

    Sayama, Osaka, 589-8511

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160-8582

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 162-8666

  • Novartis Investigative Site

    Suita, Osaka, 565-0871

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-8686

  • Novartis Investigative Site

    Tōon, Ehime, 791-0295

  • Novartis Investigative Site

    Yamagata, Yamagata, 990-9585

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236 0037

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Spain22 sites

  • Novartis Investigative Site

    Alcorcón, Madrid, 28922

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barcelona, Barcelona, 08041

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Benidorm, Valencia, 03501

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Novartis Investigative Site

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

  • Novartis Investigative Site

    Madrid, Madrid, 28007

  • Novartis Investigative Site

    Madrid, Madrid, 28040

  • Novartis Investigative Site

    Madrid, Madrid, 28041

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33006

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands, 07120

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41014

  • Novartis Investigative Site

    Valencia, Valencia, 46009

  • Novartis Investigative Site

    Valencia, Valencia, 46010

Other trials in Spain

France18 sites

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Bordeaux, 33075

  • Novartis Investigative Site

    Caen, 14021

  • Novartis Investigative Site

    Clermont-Ferrand, 63011

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Marseille, 13273

  • Novartis Investigative Site

    Nice, 06189

  • Novartis Investigative Site

    Paris, 75015

  • Novartis Investigative Site

    Paris, 75651

  • Novartis Investigative Site

    Rennes, 35062

  • Novartis Investigative Site

    Saint-Herblain Cédex, 44805

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42271

  • Novartis Investigative Site

    Strasbourg, F-67098

  • Novartis Investigative Site

    Suresnes, France, 92150

  • Novartis Investigative Site

    Toulouse, 31059

  • Novartis Investigative Site

    Vandoeuvre-Les-Nancy Cede, 54511

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

Germany16 sites

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Berlin, 10098

  • Novartis Investigative Site

    Chemnitz, 09119

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Marburg, 35039

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Nuremberg, 90419

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Weiden, 92637

Other trials in Germany

Canada13 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N2

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 2Y9

  • Novartis Investigative Site

    Hamilton, Ontario, L8N 4A6

  • Novartis Investigative Site

    London, Ontario, N6A 4L6

  • Novartis Investigative Site

    Montreal, Quebec, H2L 4M1

  • Novartis Investigative Site

    Montreal, Quebec, H2X 1N8

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Saskatoon, Saskatchewan, S7N 4H4

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy9 sites

  • Novartis Investigative Site

    Arezzo, AR, 52100

  • Novartis Investigative Site

    Candiolo, TO, 10060

  • Novartis Investigative Site

    Cremona, CR, 26100

  • Novartis Investigative Site

    Meldola, FC, 47014

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Modena, MO, 41100

  • Novartis Investigative Site

    Naples, 80132

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Roma, RM, 00152

Other trials in Italy

United Kingdom8 sites

  • Novartis Investigative Site

    Bristol, Avon, BS2 8ED

  • Novartis Investigative Site

    Colchester, CO3 3NB

  • Novartis Investigative Site

    Leicester, LE1 5WW

  • Novartis Investigative Site

    London, NW3 4QG

  • Novartis Investigative Site

    London, SW17 0QT

  • Novartis Investigative Site

    Manchester, M20 9BX

  • Novartis Investigative Site

    Northwood, Middlesex, HA6 2RN

  • Novartis Investigative Site

    Southampton, SO16 6YD

Other trials in United Kingdom

Australia6 sites

  • Novartis Investigative Site

    Footscray, Victoria, 3011

  • Novartis Investigative Site

    Heidelberg, Victoria, 3084

  • Novartis Investigative Site

    South Brisbane, Queensland, 4101

  • Novartis Investigative Site

    St Leonards, New South Wales, 2065

  • Novartis Investigative Site

    Westmead, New South Wales, 2145

  • Novartis Investigative Site

    Woodville, South Australia, 5011

Other trials in Australia

Netherlands6 sites

  • Novartis Investigative Site

    Amsterdam, 1081 HV

  • Novartis Investigative Site

    Breda, 4818 CK

  • Novartis Investigative Site

    Dordrecht, 3318AT

  • Novartis Investigative Site

    Maastricht, 6229 HX

  • Novartis Investigative Site

    Meerssen, KR, 6231

  • Novartis Investigative Site

    Rotterdam, 3075 EA

Other trials in Netherlands

Belgium5 sites

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

Other trials in Belgium

Hungary5 sites

  • Novartis Investigative Site

    Budapest, 1086

  • Novartis Investigative Site

    Budapest, H-1122

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Pécs, 7624

  • Novartis Investigative Site

    Szolnok, H-5000

Other trials in Hungary

South Korea4 sites

  • Novartis Investigative Site

    Seoul, Korea, 03722

  • Novartis Investigative Site

    Seoul, Korea, 05505

  • Novartis Investigative Site

    Seoul, Korea, 06351

  • Novartis Investigative Site

    Seoul, Korea, 110 744

Other trials in South Korea

Sweden4 sites

  • Novartis Investigative Site

    Stockholm, SE-171 76

  • Novartis Investigative Site

    Sundsvall, 851 86

  • Novartis Investigative Site

    Umeå, SE-901 85

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

Czechia3 sites

  • Novartis Investigative Site

    Brno, Czech Republic, 656 53

  • Novartis Investigative Site

    Olomouc, 775 20

  • Novartis Investigative Site

    Prague, 150 06

Other trials in Czechia

Greece3 sites

  • Novartis Investigative Site

    Athens, Greece, 115 28

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Thessaloniki, GR, 546 45

Other trials in Greece

Israel3 sites

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 5266202

  • Novartis Investigative Site

    Zrifin, 70300

Other trials in Israel

Argentina2 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    Rosario, Sante Fe, S200DSK

Other trials in Argentina

Austria2 sites

  • Novartis Investigative Site

    Linz, A-4020

  • Novartis Investigative Site

    Vienna, 1090

Other trials in Austria

Norway2 sites

  • Novartis Investigative Site

    Ålesund, NO-6026

  • Novartis Investigative Site

    Bergen, -N5021

Other trials in Norway

Poland2 sites

  • Novartis Investigative Site

    Warsaw, 02-781

  • Novartis Investigative Site

    Warsaw, 04-141

Other trials in Poland

Brazil1 site

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

Other trials in Brazil

Colombia1 site

  • Novartis Investigative Site

    Bogotá

Other trials in Colombia

Saudi Arabia1 site

  • Novartis Investigative Site

    Riyadh, 11211

Other trials in Saudi Arabia

Slovakia1 site

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 83310

Other trials in Slovakia

Switzerland1 site

  • Novartis Investigative Site

    Sankt Gallen, 9007

Other trials in Switzerland

Thailand1 site

  • Novartis Investigative Site

    Bangkok, 10700

Other trials in Thailand

About this study

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

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

Being tested
Dovitinib, Sorafenib
Keywords
Dovitinib, TKI, Renal cell cancer, RCC, mRCC
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DovitinibDrug

    Also called TKI258

    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.

  • SorafenibDrug

    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.

Study groups in NCT01223027
Study groupRoleWhat they receive
Dovitinib + best supportive care (BSC)ExperimentalPatients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule.
Receives: Drug: Dovitinib
Sorafenib + BSCActive comparatorPatients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily.
Receives: Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)

  1. Overall Survival (OS)

    Overall survival (OS) was the key secondary endpoint and was defined as the time from date of randomization to the date of death due to any cause. If a patient was not known to have died, survival was censored on the date of last contact.

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

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

    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. The primary analysis for PFS (based on central review) was also to be repeated on FAS considering the Investigator assessments and using the same analytical conventions as the primary analysis.

    Measured: Until disease progression or discontinuation of treatment due to unacceptable toxicity

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

    Overall response rate (ORR) was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR). Best overall esponse (BOR) for each patient was determined from the sequence of overall (lesion) responses according to the following rules: CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. SD = at least one SD assessment (or better) > 6 weeks after randomization (and not qualifying for CR or PR). PD = progression ≤ 17 weeks after randomization (and not qualifying for CR, PR or SD).

    Measured: Until disease progression or discontinuation of treatment due to unacceptable toxicity

  4. Time to Definitive Worsening of Karnofsky Performance Status (KPS)

    Time to definitive worsening of Karnofsky performance status (KPS) was defined as the time from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier. Definitive worsening was defined as a definitive decrease in performance status by at least one Karnofsky category (i.e. at least 10 points less) compared to Baseline. Worsening was considered definitive if no later increase above the defined threshold was observed within the course of the study. A single measure reporting a decrease in Karnofsky performance status was sufficient to consider it as definitive only if it was the last one available for this patient. Time to definitive worsening of KPS was analyzed at the time of the final analysis for PFS.

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

  5. 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

    The Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) is a validated symptom scale used in studies of patients with kidney cancer. It includes 9-items that assess pain, bone pain, fatigue, lack of energy, shortness of breath, fevers, weight loss, coughing, and blood in urine and responses to each question are answered on a 5-point Likert-type scale ranging from 0 to 4 (e.g., 0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). FKSI-DRS scores range from 0 to 36, where higher scores correspond to better outcomes (eg, fewer symptoms).

    Measured: from date of randomization, at least 2 score units

  6. Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%

    The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.

    Measured: from date of randomization

  7. Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%

    The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.

    Measured: from date of randomization

  8. Pre-dose Concentration in Plasma in Dovitinib

    Predose concentrations of dovitinib were summarized by visit using PAS. All concentration data was listed by patient and time point using FAS. Mean pre-dose concentrations along with standard deviation (SD) was plotted over time if appropriate.

    Measured: Week 2 Day 5, Week 4 Day 5, Week 6 Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2010 (estimated)
  2. Study startMar 2011
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01223027
Sponsor's protocol ID
CTKI258A2302
Other IDs
2009-015459-25, 2009
Status last verified
Nov 2015
First submitted
30 Sep 2010
Last updated
7 Dec 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24556040

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dovitinib and Sorafenib in people with Metastatic Renal Cell Carcinoma, run by Novartis Pharmaceuticals at 199 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in United States, Japan, Spain, France, Germany and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Per Independent Central Radiology Review (time frame: Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01223027, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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