Diffuse AstrocytomaPhase 4NCT03975829
Pediatric Long-Term Follow-up and Rollover Study
A Phase 4 study testing dabrafenib and trametinib in people with Diffuse Astrocytoma and Anaplastic Astrocytoma, run by Novartis Pharmaceuticals at 54 sites in 19 countries.
Trial summary
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma
- What is being tested?
- dabrafenib and trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 54 sitesin 19 countries
- Study dates
- 4 Nov 2019to 5 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
54 sites in 19 countries.
54 sites in 19 countries
United States11 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Cinn Children Hosp Medical Center
Cincinnati, Ohio, 45229-3039
Texas Childrens Hospital
Houston, Texas, 77030
Indiana Uni School of Medicine
Indianapolis, Indiana, 46202-2810
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105
Nicklaus Childrens Hospital
Miami, Florida, 33155
University of Minnesota
Minneapolis, Minnesota, 55455
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
Phoenix Children s Hospital
Phoenix, Arizona, 85016
Childrens National Hospital
Washington D.C., District of Columbia, 20010
France7 sites
Novartis Investigative Site
Brest, 29609
Novartis Investigative Site
Marseille, 13885
Novartis Investigative Site
Paris, 75231
Novartis Investigative Site
Rennes, Brittany Region, 35203
Novartis Investigative Site
Rennes, 35033
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Novartis Investigative Site
Villejuif, 94800
Germany5 sites
Novartis Investigative Site
Augsburg, 86179
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Hamburg, 20246
Italy5 sites
Novartis Investigative Site
Florence, FI, 50139
Novartis Investigative Site
Genova, GE, 16147
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Roma, RM, 00165
Novartis Investigative Site
Torino, TO, 10126
United Kingdom4 sites
Novartis Investigative Site
Liverpool, L12 2AP
Novartis Investigative Site
London, NW1 2BU
Novartis Investigative Site
London, WC1N 3JH
Novartis Investigative Site
Sutton, Surrey, SM2 5PT
Brazil3 sites
Novartis Investigative Site
Barretos, São Paulo, 14784-400
Novartis Investigative Site
São Paulo, São Paulo, 04829-310
Novartis Investigative Site
São Paulo, São Paulo, 08270-070
Canada3 sites
Novartis Investigative Site
Montreal, Quebec, H3T 1C5
Novartis Investigative Site
Toronto, Ontario, M5G 1X8
Novartis Investigative Site
Vancouver, British Columbia, V6H 3V4
Australia2 sites
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
Novartis Investigative Site
Parkville, Victoria, 3052
Czechia2 sites
Novartis Investigative Site
Brno, 625 00
Novartis Investigative Site
Prague, 150 06
Japan2 sites
Novartis Investigative Site
Osaka, Osaka, 5340021
Novartis Investigative Site
Setagaya-ku, Tokyo, 1578535
Spain2 sites
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Valencia, 46026
About this study
Official title: An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
- Conditions
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood, Anaplastic Oligodendroglioma, Glioblastoma
- Being tested
- dabrafenib, trametinib
- Keywords
- v600-mutation, neuroblastoma, Trametinib, pediatrics, Langerhans Cell Histiocytosis, low grade glioma, plexiform neurofibromas, high grade glioma, dabrafenib, NF-1
- Medical subject headings
- Astrocytoma, Oligodendroglioma, Glioblastoma, Ganglioneuroma, Ganglioglioma, Neurocytoma, Neurofibromatosis 1, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabrafenibDrug
Also called DRB436
dabrafenib oral, twice daily
trametinibDrug
Also called TMT212
trametinib oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Dabrafenib and/or trametinib | Experimental | 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 Receives: Drug: dabrafenib; Drug: trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to approximately 7 years
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: Baseline up to approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start4 Nov 2019
- Primary completion5 Nov 2026 (estimated)
- Study completion5 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse AstrocytomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975829
- Sponsor's protocol ID
- CDRB436G2401
- Other IDs
- 2023-509276-42-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 30 May 2019
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)
- ClinicalTrials.gov ID
- NCT03975829
- Acronym / sponsor ID
- CDRB436G2401
- Conditions
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood, Anaplastic Oligodendroglioma, Glioblastoma
- Keywords
- v600-mutation, neuroblastoma, Trametinib, pediatrics, Langerhans Cell Histiocytosis, low grade glioma, plexiform neurofibromas, high grade glioma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 5 Nov 2026 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dabrafenib and/or trametinib | Experimental | Drug: dabrafenib, Drug: trametinibPatients 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 |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- Subject has participated in a combination trial where dabrafenib and/or trametinib was dispensed in combination with another study medication.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dabrafenibAlso: DRB436dabrafenib oral, twice daily | Drug | Dabrafenib and/or trametinib |
| trametinibAlso: TMT212trametinib oral, once daily | Drug | Dabrafenib and/or trametinib |
Primary outcome
Number of participants with Adverse Events and Serious Adverse Events (SAEs)
Time frame: Baseline up to approximately 7 years
To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.
6 secondary outcomes
Percentage of participants with height (measured by cm or in) changes over time
Time frame: Baseline up to approximately 7 years
Percentage of participants with weight (measured by kg or lb) changes over time
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
Time frame: Baseline up to approximately 7 years
Percentage of participants with sexual maturation (measured by tanner staging criteria) changes over time
Time frame: Baseline up to approximately 7 years
Percentage of participants with cardiac function (measured by ECG) changes over time
Time frame: Baseline up to approximately 7 years
Clinical Benefit (measured by CT/MRI)
Time frame: Baseline up to approximately 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
54 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dabrafenib and trametinib in people with Diffuse Astrocytoma and Anaplastic Astrocytoma, run by Novartis Pharmaceuticals at 54 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, France, Germany, Italy, United Kingdom and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events and Serious Adverse Events (SAEs) (time frame: Baseline up to approximately 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.