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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:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Information provided by (Responsible Party):
Andrew J. Wagner, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01207492
First received: September 21, 2010
Last updated: October 3, 2016
Last verified: October 2016
Results First Received: June 8, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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]
 
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.35  (13.54) 
Gender 
[Units: Participants]
 
Female   12 
Male   5 
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 )
Study First Received: September 21, 2010
Results First Received: June 8, 2015
Last Updated: October 3, 2016
Health Authority: United States: Food and Drug Administration