ClinicaliQ Trial Snapshot
- Pediatric Long-Term Follow-up and Rollover Study — Recruiting • Phase IV • Respiratory / COPD / Asthma • NCT03975829.
- What is being tested: Long-term safety and efficacy of dabrafenib (BRAF inhibitor) and/or trametinib (MEK inhibitor) in pediatric patients who have completed prior dabrafenib/trametinib trials, with continued monitoring of treatment response and adverse effects over extended follow-up.
- Patient eligibility overview: Pediatric patients (typically under 18 years) who have successfully completed a parent dabrafenib and/or trametinib study and are eligible for continued treatment without safety contraindications, allowing seamless transition into long-term surveillance.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Eligibility Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.