Pediatric Long-Term Follow-up and Rollover Study (NCT03975829) | Clinical Trial Compass
RecruitingPhase 4
Pediatric Long-Term Follow-up and Rollover Study
United States165 participantsStarted 2019-11-04
Plain-language summary
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Who can participate
Age range1 Year – 99 Years
SexALL
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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 a…
What they're measuring
1
Number of participants with Adverse Events and Serious Adverse Events (SAEs)