A Phase 4 interventional study of dabrafenib and trametinib in Diffuse Astrocytoma, Anaplastic Astrocytoma and Astrocytoma, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 54 sites in 19 countries. Open to participants aged 1 Year to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Treatment
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's enrollment of 163 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Compared within Glioblastoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Astrocytoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
All Subjects:
For Subjects Entering the Treatment Period:
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:
Other protocol-defined inclusion/exclusion may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: trametinib
dabrafenib oral, twice daily
Also known as: DRB436
trametinib oral, once daily
Also known as: TMT212
Number of participants with Adverse Events and Serious Adverse Events (SAEs)
To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.
Time frame: Baseline up to approximately 7 years
Percentage of participants with height (measured by cm or in) changes over time
Developmental monitoring: Serial measurements of height will be collected throughout the study
Time frame: Baseline up to approximately 7 years
Percentage of participants with weight (measured by kg or lb) changes over time
Developmental monitoring: Serial measurements of weight will be collected throughout the study
Time frame: Baseline up to approximately 7 years
Percentage of participants with skeletal maturation (measured by bone age on x-ray or MRI) changes over time
Developmental monitoring: Serial measurements of skeletal maturation will be collected throughout the study
Time frame: Baseline up to approximately 7 years
Percentage of participants with sexual maturation (measured by tanner staging criteria) changes over time
Developmental monitoring: Serial measurements of sexual maturation will be collected throughout the study
Time frame: Baseline up to approximately 7 years
Percentage of participants with cardiac function (measured by ECG) changes over time
Developmental monitoring: Serial measurements of cardiac function will be collected throughout the study
Time frame: Baseline up to approximately 7 years
Clinical Benefit (measured by CT/MRI)
Disease specific clinical benefit, as determined by investigator using institutional standard of care. Investigator will measure tumor response based on the Response Assessment used for the subject in the parent protocol (Response Assessment in Neuro-Oncology (RANO) criteria for solid tumors, RECIST, NF1 Volumetric, Neuroblastoma, or LCH criteria).
Time frame: Baseline up to approximately 7 years
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Data sharing details ↗ · www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dabrafenib · Trametinib