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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03975829
Other study ID # CDRB436G2401
Secondary ID 2018-004459-19
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 4, 2019
Est. completion date May 29, 2026

Study information

Verified date May 2024
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms

  • Anaplastic Astrocytoma
  • Anaplastic Ganglioglioma
  • Anaplastic Oligodendroglioma
  • Anaplastic Pleomorphic Xanthoastrocytoma
  • Angiocentric Glioma
  • Astrocytoma
  • Central Neurocytoma
  • Cerebellar Liponeurocytoma
  • Chordoid Glioma of Third Ventricle
  • Desmoplastic Infantile Astrocytoma and Ganglioglioma
  • Diffuse Astrocytoma
  • Dysplastic Gangliocytoma of Cerebrellum
  • Extraventricular Neurocytoma
  • Gangliocytoma
  • Ganglioglioma
  • Ganglioneuroma
  • Giant Cell Astrocytoma
  • Glioblastoma
  • Glioma
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Neurofibromatosis Type 1
  • Oligodendroglioma
  • Oligodendroglioma, Childhood
  • Papillary Glioneuronal Tumor
  • Pilocytic Astrocytoma
  • Pleomorphic Xanthoastrocytoma
  • Rosette-forming Glioneurona Tumor

Intervention

Drug:
dabrafenib
dabrafenib oral, twice daily
trametinib
trametinib oral, once daily

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Israel,  Italy,  Japan,  Netherlands,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

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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