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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01223027
Registration number
NCT01223027
Ethics application status
Date submitted
30/09/2010
Date registered
18/10/2010
Date last updated
7/12/2015
Titles & IDs
Public title
Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma
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Scientific 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
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Secondary ID [1]
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2009-015459-25
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Secondary ID [2]
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CTKI258A2302
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dovitinib
Treatment: Drugs - Sorafenib
Experimental: Dovitinib + best supportive care (BSC) - Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule.
Active comparator: Sorafenib + BSC - Patients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily.
Treatment: Drugs: Dovitinib
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.
Treatment: Drugs: Sorafenib
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) Per Independent Central Radiology Review
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Assessment method [1]
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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.
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Timepoint [1]
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Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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until at least 386 deaths are documented in the clinical database.
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Secondary outcome [2]
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Progression Free Survival (PFS) Per Investigator's Radiology Review
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Assessment method [2]
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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.
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Timepoint [2]
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Until disease progression or discontinuation of treatment due to unacceptable toxicity
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Secondary outcome [3]
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Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review
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Assessment method [3]
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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).
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Timepoint [3]
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Until disease progression or discontinuation of treatment due to unacceptable toxicity
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Secondary outcome [4]
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Time to Definitive Worsening of Karnofsky Performance Status (KPS)
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Assessment method [4]
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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.
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Timepoint [4]
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from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier
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Secondary outcome [5]
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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
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Assessment method [5]
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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).
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Timepoint [5]
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from date of randomization, at least 2 score units
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Secondary outcome [6]
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Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%
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Assessment method [6]
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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.
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Timepoint [6]
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from date of randomization
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Secondary outcome [7]
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Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%
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Assessment method [7]
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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.
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Timepoint [7]
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from date of randomization
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Secondary outcome [8]
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Pre-dose Concentration in Plasma in Dovitinib
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Assessment method [8]
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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.
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Timepoint [8]
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Week 2 Day 5, Week 4 Day 5, Week 6 Day 5
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Eligibility
Key inclusion criteria
* 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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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
Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2014
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Sample size
Target
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Accrual to date
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Final
564
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - St. Leonards
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Novartis Investigative Site - Westmead
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Novartis Investigative Site - South Brisbane
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Novartis Investigative Site - Woodville
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Novartis Investigative Site - Footscray
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Novartis Investigative Site - Heidelberg
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2065 - St. Leonards
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2145 - Westmead
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4101 - South Brisbane
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5011 - Woodville
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3011 - Footscray
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3084 - Heidelberg
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Recruitment outside Australia
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Italy
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MO
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Italy
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PV
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Italy
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RM
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Italy
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TO
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Italy
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Napoli
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Japan
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Aichi
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Nagano
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Chiba
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Japan
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Yamagata
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Korea, Republic of
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Korea
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Netherlands
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KR
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Netherlands
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Dordrecht
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Netherlands
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Maastricht
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Netherlands
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Rotterdam
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Norway
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Bergen
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Norway
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Ålesund
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Poland
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Warszawa
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Saudi Arabia
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Riyadh
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Slovakia
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Slovak Republic
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Spain
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Andalucia
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Catalunya
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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Islas Baleares
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Spain
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Las Palmas de Gran Canaria
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Spain
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Madrid
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Spain
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Navarra
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Sweden
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Stockholm
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Sweden
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Sundsvall
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Sweden
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Umeå
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Sweden
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Uppsala
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Switzerland
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St. Gallen
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Thailand
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Bangkok
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United Kingdom
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Avon
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United Kingdom
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Middlesex
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United Kingdom
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Colchester
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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Country [141]
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United Kingdom
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State/province [141]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.
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Trial website
https://clinicaltrials.gov/study/NCT01223027
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01223027
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