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Dabrafenib and/or Trametinib Rollover Study

RECRUITINGPhase 4Sponsored by Novartis Pharmaceuticals
Actively Recruiting
PhasePhase 4
SponsorNovartis Pharmaceuticals
Started2017-12-28
Est. completion2029-12-18
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
Locations5 sites

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

Age: 18 Years – 100 YearsHealthy volunteers accepted
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.

Conditions7

CancerHigh Grade GliomaLung CancerMelanomaNon Small Cell Lung CancerRare CancersSolid Tumor

Locations5 sites

Arizona

2 sites
Honor Health Research Institute
Scottsdale, Arizona, 85258
Kristina Will480-323-3990Kristina.Will@honorhealth.com
Honor Health Research Institute
Scottsdale, Arizona, 85258
Michael Gordon

Maryland

1 site
National Institute Of Health
Bethesda, Maryland, 20892

Ohio

1 site
James Cancer Hospital and Solove Research Institute Ohio State
Columbus, Ohio, 43210

Texas

1 site
Mary Crowley Cancer Research
Dallas, Texas, 75251

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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