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Study of Sutent®/Sunitinib (SU11248) in Subjects With NF-1 Plexiform Neurofibromas

This study has suspended participant recruitment.
(1 patient died of uncertain cause but possibly related to drug. Regulatory currently reviewing)
Sponsor:
Collaborators:
United States Department of Defense
Pfizer
Information provided by (Responsible Party):
Chie-Schin Shih, Indiana University
ClinicalTrials.gov Identifier:
NCT01402817
First received: July 25, 2011
Last updated: June 7, 2016
Last verified: June 2016
Results First Received: March 30, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Neurofibromatosis
NF1
Plexiform Neurofibromas
Intervention: Drug: Sutent®/Sunitinib

  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
Sutent®/Sunitinib Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.

Participant Flow:   Overall Study
    Sutent®/Sunitinib
STARTED   19 
COMPLETED   8 
NOT COMPLETED   11 
Withdrawal by Subject                3 
Study Suspended by FDA                8 



  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
Sutent®/Sunitinib Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.

Baseline Measures
   Sutent®/Sunitinib 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
 
<=18 years   15 
Between 18 and 65 years   4 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   11 
Male   8 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   19 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   1 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   15 
More than one race   2 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   19 


  Outcome Measures
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1.  Primary:   Disease Response   [ Time Frame: 6 months ]

2.  Secondary:   Volumetric Disease Evaluation   [ 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Chie-Schin Shih, MD
Organization: Indiana University School of Medicine - Pediatrics
phone: 317-948-8568
e-mail: shih2@iu.edu



Responsible Party: Chie-Schin Shih, Indiana University
ClinicalTrials.gov Identifier: NCT01402817     History of Changes
Other Study ID Numbers: 1104-07
Study First Received: July 25, 2011
Results First Received: March 30, 2016
Last Updated: June 7, 2016
Health Authority: United States: Food and Drug Administration