An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)
Novartis Pharmaceuticals
Summary
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Eligibility
- Age range
- 1–99 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: All Subjects: * Written informed consent, according to local guidelines, signed by the subjects and/or by the parents or legal guardian prior to any study related screening procedures are performed. * Participation in a Novartis sponsored study such as CTMT212X2101, CDRB436G2201, CDRB436A2102, regardless of current age. * Parent study (or cohort of parent study) is planned to be closed. * Subject has demonstrated compliance, as assessed by the investigator, within the parent study protocol requirement(s). * Willingness and ability to comply with scheduled visits, trea…
Interventions
- Drugdabrafenib
dabrafenib oral, twice daily
- Drugtrametinib
trametinib oral, once daily
Locations (55)
- Phoenix Children s HospitalPhoenix, Arizona
- Childrens National HospitalWashington D.C., District of Columbia
- Nicklaus Childrens HospitalMiami, Florida
- Indiana Uni School of MedicineIndianapolis, Indiana
- Johns Hopkins HospitalBaltimore, Maryland
- Dana Farber Cancer InstituteBoston, Massachusetts