RecruitingRecruiting
Pediatric Long-Term Follow-up and Rollover Study
NCT03975829 · Novartis
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Eligibility criteria
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 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.
Study design
Enrollment target: 165 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2019-11-04
Estimated completion: 2026-11-05
Last updated: 2026-06-02
Interventions
Drug: dabrafenibDrug: trametinib
Primary outcomes
- • Number of participants with Adverse Events and Serious Adverse Events (SAEs) (Baseline up to approximately 7 years)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · +41613241111
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (55)
Phoenix Children s HospitalActive Not Recruiting
Phoenix, Arizona, United States
Childrens National HospitalActive Not Recruiting
Washington D.C., District of Columbia, United States
Nicklaus Childrens HospitalActive Not Recruiting
Miami, Florida, United States
Indiana Uni School of MedicineActive Not Recruiting
Indianapolis, Indiana, United States
Johns Hopkins HospitalActive Not Recruiting
Baltimore, Maryland, United States
Dana Farber Cancer InstituteActive Not Recruiting
Boston, Massachusetts, United States
University of MinnesotaActive Not Recruiting
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CtrActive Not Recruiting
New York, New York, United States
Cinn Children Hosp Medical CenterActive Not Recruiting
Cincinnati, Ohio, United States
St Jude Childrens Research HospitalActive Not Recruiting
Memphis, Tennessee, United States
Texas Childrens HospitalCompleted
Houston, Texas, United States
Novartis Investigative SiteActive Not Recruiting
CABA, Buenos Aires, Argentina
Novartis Investigative SiteActive Not Recruiting
Darlinghurst, New South Wales, Australia
Novartis Investigative SiteActive Not Recruiting
Parkville, Victoria, Australia
Novartis Investigative SiteCompleted
Brussels, Belgium
Novartis Investigative SiteActive Not Recruiting
Barretos, São Paulo, Brazil
Novartis Investigative SiteActive Not Recruiting
São Paulo, São Paulo, Brazil
Novartis Investigative SiteCompleted
São Paulo, São Paulo, Brazil
Novartis Investigative SiteActive Not Recruiting
Vancouver, British Columbia, Canada
Novartis Investigative SiteActive Not Recruiting
Toronto, Ontario, Canada
Novartis Investigative SiteCompleted
Montreal, Quebec, Canada
Novartis Investigative SiteActive Not Recruiting
Brno, Czechia
Novartis Investigative SiteActive Not Recruiting
Prague, Czechia
Novartis Investigative SiteActive Not Recruiting
Copenhagen, Denmark
Novartis Investigative SiteActive Not Recruiting
Tampere, Finland
Novartis Investigative SiteActive Not Recruiting
Rennes, Brittany Region, France
Novartis Investigative SiteCompleted
Brest, France
Novartis Investigative SiteActive Not Recruiting
Marseille, France
Novartis Investigative SiteActive Not Recruiting
Paris, France
Novartis Investigative SiteActive Not Recruiting
Rennes, France
Novartis Investigative SiteActive Not Recruiting
Vandœuvre-lès-Nancy, France
Novartis Investigative SiteActive Not Recruiting
Villejuif, France
Novartis Investigative SiteActive Not Recruiting
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative SiteActive Not Recruiting
Augsburg, Germany
Novartis Investigative SiteActive Not Recruiting
Berlin, Germany
Novartis Investigative SiteActive Not Recruiting
Essen, Germany
Novartis Investigative SiteActive Not Recruiting
Hamburg, Germany
Novartis Investigative SiteActive Not Recruiting
Petah Tikva, Israel
Novartis Investigative SiteActive Not Recruiting
Florence, FI, Italy
Novartis Investigative SiteActive Not Recruiting
Genova, GE, Italy
Novartis Investigative SiteActive Not Recruiting
Milan, MI, Italy
Novartis Investigative SiteActive Not Recruiting
Roma, RM, Italy
Novartis Investigative SiteActive Not Recruiting
Torino, TO, Italy
Novartis Investigative SiteActive Not Recruiting
Setagaya-ku, Tokyo, Japan
Novartis Investigative SiteActive Not Recruiting
Osaka, Japan
Novartis Investigative SiteActive Not Recruiting
Utrecht, Netherlands
Novartis Investigative SiteActive Not Recruiting
Moscow, Russia
Novartis Investigative SiteActive Not Recruiting
Madrid, Spain
Novartis Investigative SiteActive Not Recruiting
Valencia, Spain
Novartis Investigative SiteCompleted
Stockholm, Sweden
Novartis Investigative SiteActive Not Recruiting
Sutton, Surrey, United Kingdom
Novartis Investigative SiteActive Not Recruiting
Liverpool, United Kingdom
Novartis Investigative SiteActive Not Recruiting
London, United Kingdom
Novartis Investigative SiteActive Not Recruiting
London, United Kingdom