Melanoma Clinical Trial

Dabrafenib and/or Trametinib Rollover Study

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.

View Eligibility Criteria

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 is for people with:

Melanoma

Phase:

Phase 4

Estimated Enrollment:

100

Study ID:

NCT03340506

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 27 Locations for this study

See Locations Near You

Honor Health Research Institute
Scottsdale Arizona, 85258, United States More Info
Angela Neuckranz
Contact
480-323-3990
[email protected]
Michael Gordon
Principal Investigator
National Institute Of Health
Bethesda Maryland, 20892, United States More Info
Michelle Capozzoli
Contact
[email protected]
Robert Kreitman
Principal Investigator
James Cancer Hospital and Solove Research Institute Ohio State
Columbus Ohio, 43210, United States
Mary Crowley Cancer Research
Dallas Texas, 75251, United States
Novartis Investigative Site
Buenos Aires , C1125, Argentina
Novartis Investigative Site
Innsbruck , A-602, Austria
Novartis Investigative Site
Beijing , 10003, China
Novartis Investigative Site
Copenhagen , DK-21, Denmark
Novartis Investigative Site
Lyon , 69373, France
Novartis Investigative Site
Nantes Cedex 1 , 44093, France
Novartis Investigative Site
Paris , 75970, France
Novartis Investigative Site
Villejuif , 94800, France
Novartis Investigative Site
Mannheim Baden Wuerttemberg, 68305, Germany
Novartis Investigative Site
Berlin , 13353, Germany
Novartis Investigative Site
Hamburg , 20246, Germany
Novartis Investigative Site
Heidelberg , 69120, Germany
Novartis Investigative Site
Budapest , H 112, Hungary
Novartis Investigative Site
Debrecen , 4032, Hungary
Novartis Investigative Site
Kashiwa Chiba, 277 8, Japan
Novartis Investigative Site
Chuo ku Tokyo, 104 0, Japan
Novartis Investigative Site
Rotterdam , 3075 , Netherlands
Novartis Investigative Site
Utrecht , 3584C, Netherlands
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Madrid , 28040, Spain
Novartis Investigative Site
Madrid , 28041, Spain
Novartis Investigative Site
Madrid , 28050, Spain
Novartis Investigative Site
Songkla , 90110, Thailand

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 4

Estimated Enrollment:

100

Study ID:

NCT03340506

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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