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Активно (без набиране) Фаза 4 NCT03975829

Pediatric Long-Term Follow-up and Rollover Study

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Diffuse Astrocytoma Anaplastic Astrocytoma Astrocytoma Oligodendroglioma, Childhood Anaplastic Oligodendroglioma Glioblastoma Pilocytic Astrocytoma Giant Cell Astrocytoma Pleomorphic Xanthoastrocytoma Anaplastic Pleomorphic Xanthoastrocytoma Angiocentric Glioma Chordoid Glioma of Third Ventricle Gangliocytoma Ganglioglioma Anaplastic Ganglioglioma Dysplastic Gangliocytoma of Cerebrellum Desmoplastic Infantile Astrocytoma and Ganglioglioma Papillary Glioneuronal Tumor Rosette-forming Glioneuronal Tumor Central Neurocytoma Extraventricular Neurocytoma Cerebellar Liponeurocytoma Neurofibromatosis Type 1

Спонсор: Novartis Pharmaceuticals

Налично на: БГ
Обобщение
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Кой може да участва
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.
Места на провеждане 18
Argentina (1)
Novartis Investigative Site
CABA , Buenos Aires
Австралия (1)
Novartis Investigative Site
Darlinghurst , New South Wales
Белгия (1)
Novartis Investigative Site
Brussels
Бразилия (1)
Novartis Investigative Site
Barretos , São Paulo
Канада (1)
Novartis Investigative Site
Vancouver , British Columbia
Чехия (1)
Novartis Investigative Site
Brno
Дания (1)
Novartis Investigative Site
Copenhagen
Финландия (1)
Novartis Investigative Site
Tampere
Франция (1)
Novartis Investigative Site
Rennes , Brittany Region
Израел (1)
Novartis Investigative Site
Petah Tikva
Италия (1)
Novartis Investigative Site
Florence , FI
Япония (1)
Novartis Investigative Site
Setagaya-ku , Tokyo
Нидерландия (1)
Novartis Investigative Site
Utrecht
Russia (1)
Novartis Investigative Site
Moscow
Испания (1)
Novartis Investigative Site
Madrid
Швеция (1)
Novartis Investigative Site
Stockholm
Великобритания (1)
Novartis Investigative Site
Sutton , Surrey
САЩ (1)
Phoenix Children s Hospital
Phoenix , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
1 Year
Максимална възраст
99 Years
Здрави доброволци
Не
Начална дата
04.11.2019
Крайна дата
05.11.2026
Регистрационен номер
NCT03975829
Източник
anzctr
Запитване за медицински туризъм

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