Glioblastoma Clinical Trial
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | May 29, 2026 |
Est. primary completion date | May 29, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Novartis Investigative Site | Caba | Buenos Aires |
Australia | Novartis Investigative Site | Darlinghurst | New South Wales |
Australia | Novartis Investigative Site | Parkville | Victoria |
Belgium | Novartis Investigative Site | Bruxelles | |
Brazil | Novartis Investigative Site | Barretos | SP |
Brazil | Novartis Investigative Site | Sao Paulo | SP |
Brazil | Novartis Investigative Site | Sao Paulo | SP |
Canada | Novartis Investigative Site | Montreal | Quebec |
Canada | Novartis Investigative Site | Toronto | Ontario |
Canada | Novartis Investigative Site | Vancouver | British Columbia |
Czechia | Novartis Investigative Site | Brno | |
Czechia | Novartis Investigative Site | Praha 5 | |
Denmark | Novartis Investigative Site | Copenhagen | |
Finland | Novartis Investigative Site | Tampere | |
France | Novartis Investigative Site | Brest Cedex | Finistere |
France | Novartis Investigative Site | Marseille Cedex 05 | |
France | Novartis Investigative Site | Paris | |
France | Novartis Investigative Site | Rennes | Bretagne |
France | Novartis Investigative Site | Vandoeuvre Les Nancy | |
France | Novartis Investigative Site | Villejuif | |
Germany | Novartis Investigative Site | Augsburg | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Essen | |
Germany | Novartis Investigative Site | Hamburg | |
Germany | Novartis Investigative Site | Koeln | |
Israel | Novartis Investigative Site | Petach-Tikva | |
Italy | Novartis Investigative Site | Firenze | FI |
Italy | Novartis Investigative Site | Genova | GE |
Italy | Novartis Investigative Site | Milano | MI |
Italy | Novartis Investigative Site | Roma | RM |
Italy | Novartis Investigative Site | Torino | TO |
Japan | Novartis Investigative Site | Osaka | |
Japan | Novartis Investigative Site | Setagaya-ku | Tokyo |
Netherlands | Novartis Investigative Site | Utrecht | CS |
Russian Federation | Novartis Investigative Site | Moscow | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Valencia | |
Sweden | Novartis Investigative Site | Stockholm | |
United Kingdom | Novartis Investigative Site | Liverpool | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | Sutton | Surrey |
United States | Johns Hopkins University IDS Pharmacy | Baltimore | Maryland |
United States | Dana Farber Cancer Institute . | Boston | Massachusetts |
United States | Cinn Children Hosp Medical Center | Cincinnati | Ohio |
United States | Texas Children's Hospital | Houston | Texas |
United States | Indiana Uni School of Medicine . | Indianapolis | Indiana |
United States | St Jude Childrens Research Hospital . | Memphis | Tennessee |
United States | Nicklaus Childrens Hospital | Miami | Florida |
United States | University of Minnesota . | Minneapolis | Minnesota |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Phoenix Children's Hospital . | Phoenix | Arizona |
United States | Childrens National Hospital CQTI571A2306 | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Russian Federation, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline up to approximately 7 years | |
Secondary | 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 | Baseline up to approximately 7 years | |
Secondary | 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 | Baseline up to approximately 7 years | |
Secondary | 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 | Baseline up to approximately 7 years | |
Secondary | 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 | Baseline up to approximately 7 years | |
Secondary | 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 | Baseline up to approximately 7 years | |
Secondary | 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). | Baseline up to approximately 7 years |
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