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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
dabrafenib monotherapy 		Patients in this study may receive: - monotherapy of dabrafenib
  • Drug: dabrafenib
    dabrafenib is available in capsules (50mg and 75mg) taken twice a day
Experimental
trametinib monotherapy 		Patients in this study may receive: - monotherapy of trametinib
  • Drug: trametinib
    trametinib is available in tablets (0.5mg, 2mg dose)
Experimental
Combination therapy (dabrafenib & trametinib) 		Patients in this study may receive: - the combination of dabrafenib and trametinib
  • 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)

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.