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  
Number of Participants  
[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