Pediatric Long-Term Follow-up and Rollover Study (NCT03975829) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Pediatric Long-Term Follow-up and Rollover Study
United States, Argentina, Australia165 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 range
1 Year – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a long-term follow-up and rollover study, does my child need to have already been in a previous related trial to be considered for this one, and is that window still open given that it's no longer recruiting new participants?
2This study is focused on tracking adverse events and serious adverse events over time — what kinds of safety signals or side effects has the team been watching for in children with my child's specific tumor type, such as a pilocytic astrocytoma or ganglioglioma?
3Since this trial is Phase 4 and focused on long-term safety monitoring rather than testing a new treatment, how does participating compare to simply continuing standard follow-up care with our current oncology team?
4What does 'active not recruiting' mean for my child's situation — could there be any pathway to join, or would our best next step be to look for a different open trial or stay the course with standard treatment?
5Given that this study covers a wide range of pediatric brain tumor types including neurofibromatosis type 1, how would my child's specific diagnosis affect what the researchers would be monitoring and how frequently we'd need to come in for visits?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Adverse Events and Serious Adverse Events (SAEs)