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

Who is this study for? Patients with Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers, High Grade Glioma
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Honor Health Research Institute
RECRUITING
Scottsdale
Maryland
National Institute Of Health
RECRUITING
Bethesda
Ohio
James Cancer Hospital and Solove Research Institute Ohio State
COMPLETED
Columbus
Texas
Mary Crowley Cancer Research
COMPLETED
Dallas
Other Locations
Argentina
Novartis Investigative Site
COMPLETED
Buenos Aires
Austria
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Innsbruck
China
Novartis Investigative Site
COMPLETED
Beijing
Denmark
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Copenhagen
France
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lyon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nantes
Novartis Investigative Site
COMPLETED
Paris
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Villejuif
Germany
Novartis Investigative Site
COMPLETED
Berlin
Novartis Investigative Site
COMPLETED
Hamburg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Heidelberg
Novartis Investigative Site
COMPLETED
Mannheim
Hungary
Novartis Investigative Site
COMPLETED
Budapest
Novartis Investigative Site
COMPLETED
Debrecen
Japan
Novartis Investigative Site
COMPLETED
Chuo Ku
Novartis Investigative Site
COMPLETED
Kashiwa
Netherlands
Novartis Investigative Site
COMPLETED
Rotterdam
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Utrecht
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
COMPLETED
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Thailand
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Songkhla
Contact Information
Primary
Novartis Pharmaceuticals
Novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2017-12-28
Estimated Completion Date: 2027-12-21
Participants
Target number of participants: 100
Treatments
Experimental: dabrafenib monotherapy
Patients in this study may receive:~\- monotherapy of dabrafenib
Experimental: trametinib monotherapy
Patients in this study may receive:~\- monotherapy of trametinib
Experimental: Combination therapy (dabrafenib & trametinib)
Patients in this study may receive:~\- the combination of dabrafenib and trametinib
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov