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, treatment plans and any other
study procedures.
For Subjects Entering the Treatment Period:
- Subject is currently receiving treatment with dabrafenib/trametinib monotherapy or
combination within a Novartis Sponsored Drug Development study. Note that subjects who
were on the chemotherapy arm of the CDRB436G2201 study are eligible for treatment
period of this study only after crossing over into the experimental treatment arm of
the CDRB436G2201 study
- In the opinion of the investigator is likely to benefit from continued treatment.
Key Exclusion Criteria:
All Subjects:
- Subject has participated in a combination trial where dabrafenib and/or trametinib was
dispensed in combination with another study medication.
For Subjects Entering the Treatment Period:
- Subject has permanently discontinued from study treatment in the parent protocol due
to any reason.
- Treatment with dabrafenib and/or trametinib for the subject's indication is approved
for marketing and the appropriate dosage form is commercially available and reimbursed
in the local country
- Subject currently has unresolved drug related severe toxicities for which dabrafenib
and/or trametinib dosing has been interrupted in the parent study. If the subject
should meet criteria to resume treatment on the parent protocol then they may be
eligible for treatment in this study.
Other protocol-defined inclusion/exclusion may apply.
