A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
163
dabrafenib oral, twice daily
trametinib oral, once daily
Phoenix Children s Hospital
Phoenix, Arizona, United States
Childrens National Hospital
Washington D.C., District of Columbia, United States
Nicklaus Childrens Hospital
Miami, Florida, United States
Indiana Uni School of Medicine
Indianapolis, Indiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Number of participants with Adverse Events and Serious Adverse Events (SAEs)
To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.
Time frame: Baseline up to approximately 7 years
Percentage of participants with height (measured by cm or in) changes over time
Developmental monitoring: Serial measurements of height will be collected throughout the study
Time frame: Baseline up to approximately 7 years
Percentage of participants with weight (measured by kg or lb) changes over time
Developmental monitoring: Serial measurements of weight will be collected throughout the study
Time frame: Baseline up to approximately 7 years
Percentage of participants with skeletal maturation (measured by bone age on x-ray or MRI) changes over time
Developmental monitoring: Serial measurements of skeletal maturation will be collected throughout the study
Time frame: Baseline up to approximately 7 years
Percentage of participants with sexual maturation (measured by tanner staging criteria) changes over time
Developmental monitoring: Serial measurements of sexual maturation will be collected throughout the study
Time frame: Baseline up to approximately 7 years
Percentage of participants with cardiac function (measured by ECG) changes over time
Developmental monitoring: Serial measurements of cardiac function will be collected throughout the study
Time frame: Baseline up to approximately 7 years
Clinical Benefit (measured by CT/MRI)
Disease specific clinical benefit, as determined by investigator using institutional standard of care. Investigator will measure tumor response based on the Response Assessment used for the subject in the parent protocol (Response Assessment in Neuro-Oncology (RANO) criteria for solid tumors, RECIST, NF1 Volumetric, Neuroblastoma, or LCH criteria).
Time frame: Baseline up to approximately 7 years
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