Informations générales (source: ClinicalTrials.gov)
Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study
Interventional
Phase 4
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2017
décembre 2027
16 octobre 2024
This study is to provide access for patients who are receiving treatment with dabrafenib
and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical
Affairs or a former GSK-sponsored study who have fulfilled the requirements for the
primary objective, and who are judged by the investigator as benefiting from continued
treatment in the parent study as judged by the Investigator at the completion of the
parent study.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:47 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Novartis Investigative Site - 44093 - Nantes Cedex 1 - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 75970 - Paris - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 94800 - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or
combination within a Novartis or former GSK sponsored study which has fulfilled the
requirements for the primary objective.
- In the opinion of the Investigator would benefit from continued treatment.
- Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or
combination within a Novartis or former GSK sponsored study which has fulfilled the
requirements for the primary objective.
- In the opinion of the Investigator would benefit from continued treatment.
- Patient has been previously permanently discontinued from study treatment in the
parent protocol.
- Patient's indication is commercially available and reimbursed in the local country.
- Patient currently has unresolved toxicities for which dabrafenib and/or trametinib
dosing has been interrupted in the parent study.