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Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01207492
First Posted: September 23, 2010
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Information provided by (Responsible Party):
Andrew J. Wagner, MD, PhD, Dana-Farber Cancer Institute
Results First Submitted: June 8, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pigmented Villonodular Synovitis
Diffuse-type Giant Cell Tumor
Tenosynovial Giant Cell Tumor
Intervention: Drug: nilotinib

  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
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Reporting Groups
  Description
Nilotinib

Nilotinib 200 mg taken as 400 mg twice daily, continuously

nilotinib: Taken orally twice daily


Participant Flow:   Overall Study
    Nilotinib
STARTED   17 
COMPLETED   2 
NOT COMPLETED   15 
Still on study                1 
Withdrawal by Subject                9 
Physician Decision                1 
Progressive disease                3 
Toxicity                1 



  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.
No text entered.

Reporting Groups
  Description
Nilotinib

Nilotinib 200 mg taken as 400 mg twice daily, continuously

nilotinib: Taken orally twice daily


Baseline Measures
   Nilotinib 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      15  88.2% 
>=65 years      2  11.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.35  (13.54) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  70.6% 
Male      5  29.4% 
Region of Enrollment 
[Units: Participants]
 
United States   17 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Progression Free Survival   [ Time Frame: 6 months ]

2.  Secondary:   Overall Tumor Response Rate (OR)   [ Time Frame: 2 years ]

3.  Secondary:   Clinical Benefit Rate   [ Time Frame: 6 months ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Andrew Wagner, MD, PhD
Organization: Dana-Farber Cancer Institute
phone: 617.632.5204
e-mail: andrew_wagner@dfci.harvard.edu



Responsible Party: Andrew J. Wagner, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01207492     History of Changes
Other Study ID Numbers: 10-179
YUS23T ( Other Identifier: Novartis )
First Submitted: September 21, 2010
First Posted: September 23, 2010
Results First Submitted: June 8, 2015
Results First Posted: June 25, 2015
Last Update Posted: April 4, 2017