Pediatric Long-Term Follow-up and Rollover Study

Official Title

An Open Label, Multi-centre Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)

Summary:

A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.

Trial Description

Primary Outcome:

• Number of participants with Adverse Events and Serious Adverse Events (SAEs)

• Percentage of participants with height (measured by cm or in) changes over time
• Percentage of participants with weight (measured by kg or lb) changes over time
• Percentage of participants with skeletal maturation (measured by bone age on x-ray or MRI) changes over time
• Percentage of participants with sexual maturation (measured by tanner staging criteria) changes over time
• Percentage of participants with cardiac function (measured by ECG) changes over time
• Clinical Benefit (measured by CT/MRI)

View this trial on ClinicalTrials.gov