Purpose

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

Conditions

Eligibility

Eligible Ages
Between 1 Year and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dabrafenib and/or trametinib
Patients in this study may receive one of the following treatments received in the parent study which are: - Patients who received monotherapy of either of dabrafenib or trametinib - Patients who received combination of dabrafenib and trametinib - Patients who discontinued treatment on parent study are still offered to participate in long-term follow-up
  • Drug: dabrafenib
    dabrafenib oral, twice daily
    Other names:
    • DRB436
  • Drug: trametinib
    trametinib oral, once daily
    Other names:
    • TMT212

Recruiting Locations

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Jessica Sollitto
212-639-3112
dunkel@MSKCC.ORG

More Details

NCT ID
NCT03975829
Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.