Dabrafenib and/or Trametinib Rollover Study

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

ClinicalTrials.gov Identifier: NCT03340506

Novartis Reference Number: CDRB436X2X02B

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Melanoma
Non Small Cell Lung Cancer
Solid Tumor
Rare Cancers
High Grade Glioma
Phase 
Phase 4
Overall status 
Recruiting
Enrollment count 
100 participants
Start date 
Dec 28, 2017
Completion date 
Jul 17, 2023
Gender 
All
Age(s)
18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug
dabrafenib
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
Drug
trametinib
trametinib is available in tablets (0.5mg, 2mg dose)

Eligibility Criteria

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.

Exclusion Criteria:

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.

Study Locations

United States
Honor Health Research Institute
Recruiting
Scottsdale, 85258
Arizona
United States
James Cancer Hospital and Solove Research Institute Ohio State
Recruiting
Columbus, 43210
Ohio
United States
Mary Crowley Cancer Research
Recruiting
Dallas, 75251
Texas
United States
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, C1125ABE
-
Argentina
France
Novartis Investigative Site
Recruiting
Paris, 75970
-
France
Hungary
Novartis Investigative Site
Active, not recruiting
Budapest, H 1122
-
Hungary
Novartis Investigative Site
Active, not recruiting
Debrecen, 4032
-
Hungary
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28040
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28050
-
Spain
Thailand
Novartis Investigative Site
Recruiting
Songkla, 90110
-
Thailand

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]