Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Phase II Study of Gleevec/Imatinib Mesylate (STI-571, NCS 716051) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01673009
First received: August 22, 2012
Last updated: April 5, 2016
Last verified: April 2016
Results First Received: February 24, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neurofibromatosis
Intervention: Drug: Gleevec

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Administration of Gleevec

Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.

Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.


Participant Flow:   Overall Study
    Administration of Gleevec  
STARTED     36  
COMPLETED     23  
NOT COMPLETED     13  
Physician Decision                 5  
Withdrawal by Subject                 8  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Administration of Gleevec

Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.

Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.


Baseline Measures
    Administration of Gleevec  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     25  
Between 18 and 65 years     11  
>=65 years     0  
Gender  
[units: participants]
 
Female     17  
Male     19  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     34  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     32  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline in Tumor Volume at 6 Months   [ Time Frame: baseline to 6 months ]

2.  Secondary:   Serum Bioactivity   [ Time Frame: 7 days and 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kent Robertson MD PhD
Organization: Indiana University
phone: 317-944-8784
e-mail: krobert@iu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01673009     History of Changes
Other Study ID Numbers: 0512-25
Study First Received: August 22, 2012
Results First Received: February 24, 2016
Last Updated: April 5, 2016
Health Authority: United States: Food and Drug Administration