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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01223027
First received: September 30, 2010
Last updated: November 5, 2015
Last verified: November 2015
Results First Received: June 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Renal Cell Carcinoma
Interventions: Drug: Dovitinib
Drug: Sorafenib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dovitinib + Best Supportive Care (BSC) Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Sorafenib + BSC Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.

Participant Flow:   Overall Study
    Dovitinib + Best Supportive Care (BSC)   Sorafenib + BSC
STARTED   284   286 
COMPLETED   10 [1]   9 [1] 
NOT COMPLETED   274   277 
Adverse Event                20                10 
Death                42                42 
Lost to Follow-up                2                1 
Physician Decision                4                8 
Progressive Disease                167                183 
Protocol Violation                2                1 
Subject/guardian decicion                18                16 
New therapy for study indication                17                8 
Study terminated by sponsor                2                8 
[1] Completed = Ongoing at data cut-off of 25-Jan-2013



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) consisted of all randomized patients.

Reporting Groups
  Description
Dovitinib + Best Supportive Care (BSC) Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
Sorafenib + BSC Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
Total Total of all reporting groups

Baseline Measures
   Dovitinib + Best Supportive Care (BSC)   Sorafenib + BSC   Total 
Overall Participants Analyzed 
[Units: Participants]
 284   286   570 
Age, Customized 
[Units: Participants]
     
< 65 years   187   165   352 
>= 65 years   97   121   218 
Gender 
[Units: Participants]
     
Female   71   67   138 
Male   213   219   432 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   233   232   465 
Asian   42   40   82 
Black   3   5   8 
Unknown   1   6   7 
Other   5   3   8 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 74.9  (15.39)   75.5  (15.96)   75.2  (15.67) 
Karnofsky performance score 
[Units: Participants]
     
100 -Normal no complaints; no evidence of disease   83   73   156 
90 - Able to carry on normal activity   93   101   194 
80 - Normal activity with efforts   73   83   156 
70 - Cares for self   35   29   64 
Memorial Sloan Kettering Cancer Center Risk Criteria (MSKCC) risk group [1] 
[Units: Participants]
     
Favorable   70   65   135 
Intermediate   156   155   311 
Poor   54   61   115 
Missing   4   5   9 
[1]

Pts were place into 3 distinct risk groups based on the number of risk factors that the patient had at baseline:

Low Karnofsky Performance Status: <80%, Low serum hemoglobin: males (≤ 13 g/dL); females (≤ 11.5 g/dL), High corrected serum calcium: ≥ 10 mg/dL. Pts in the favorable group are expected to live longer while patients in the poor risk group are expected to die sooner than the patients in the other groups.

Favorable = Pt. had none of the risks; Intermediate = Patient had 1 risk factor; Poor = Pt. had 2 or 3 risk factors Missing = not enough information at baseline to categorize



  Outcome Measures
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1.  Primary:   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) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: until at least 386 deaths are documented in the clinical database. ]

3.  Secondary:   Progression Free Survival (PFS) Per Investigator's Radiology Review   [ Time Frame: Until disease progression or discontinuation of treatment due to unacceptable toxicity ]

4.  Secondary:   Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review   [ Time Frame: Until disease progression or discontinuation of treatment due to unacceptable toxicity ]

5.  Secondary:   Time to Definitive Worsening of Karnofsky Performance Status (KPS)   [ Time Frame: from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier ]

6.  Secondary:   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   [ Time Frame: from date of randomization, at least 2 score units ]

7.  Secondary:   Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%   [ Time Frame: from date of randomization ]

8.  Secondary:   Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%   [ Time Frame: from date of randomization ]

9.  Secondary:   Pre-dose Concentration in Plasma in Dovitinib   [ Time Frame: Week 2 Day 5, Week 4 Day 5, Week 6 Day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registry@novartis.com


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 ( EudraCT Number )
Study First Received: September 30, 2010
Results First Received: June 29, 2015
Last Updated: November 5, 2015
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)
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency