Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01478373
First received: November 16, 2011
Last updated: July 14, 2015
Last verified: July 2015
Results First Received: July 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumors
Intervention: Drug: Dovitinib (TKI258)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
39 Patients enrolled. One patient had a protocol deviation which excluded him from the Full Analysis Set.

Reporting Groups
  Description
Dovitinib Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.

Participant Flow for 2 periods

Period 1:   Treatment Phase
    Dovitinib  
STARTED     39  
COMPLETED     38  
NOT COMPLETED     1  
Protocol Violation                 1  

Period 2:   Survival Phase
    Dovitinib  
STARTED     38  
COMPLETED     0  
NOT COMPLETED     38  
Adverse Event                 8  
Protocol Violation                 1  
crossover to another study                 2  
Progressive Disease                 27  



  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 - All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.

Reporting Groups
  Description
Dovitinib Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.

Baseline Measures
    Dovitinib  
Number of Participants  
[units: participants]
  38  
Age  
[units: Years]
Mean (Standard Deviation)
  59.2  (10.14)  
Gender  
[units: Participants]
 
Female     16  
Male     22  



  Outcome Measures
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1.  Primary:   Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease   [ Time Frame: 12 Weeks ]

2.  Secondary:   Progression-free Survival (PFS) of Patients Treated With Dovitinib   [ Time Frame: 9 months ]

3.  Secondary:   Time to Treatment Failure (TTF)of Patients Treated With Dovitinib   [ Time Frame: 9 months ]

4.  Secondary:   Duration of Response or Stable Disease (SD)   [ Time Frame: 9 months ]

5.  Secondary:   Time to Tumor Progression (TTP)of Patients Treated With Dovitinib   [ Time Frame: 9 months ]

6.  Secondary:   Overall Response Rate (ORR)of Patients Treated With Dovitinib   [ Time Frame: Baseline, 12 weeks ]

7.  Secondary:   Overall Survival (OS) of Patients Treated With Dovitinib   [ Time Frame: 21 months (9 months of estimated treatment plus 12 months of survival follow up) ]

8.  Secondary:   DCR (CR+PR+SD) at the End of Treatment   [ Time Frame: End of Treatment ]


  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


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01478373     History of Changes
Other Study ID Numbers: CTKI258AIC02, 2011-001725-24
Study First Received: November 16, 2011
Results First Received: July 14, 2015
Last Updated: July 14, 2015
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Finland: Finnish Medicines Agency
Belgium: Federal Agency for Medicinal Products and Health Products