Dabrafenib and/or Trametinib Rollover Study



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Skin Cancer, Cancer, Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/19/2018
Start Date:December 28, 2017
End Date:July 17, 2023
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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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

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 n
the parent study as judged by the Investigator at the completion of the parent study.


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 has participated in a combination trial where dabrafenib and/or trametinib was
dispensed in combination with another study medication.

- Patient currently has unresolved toxicities for which dabrafenib and/or trametinib
dosing has been interrupted in the parent study.
We found this trial at
4
sites
Dallas, Texas 75246
Principal Investigator: Minal Barve
Phone: 214-658-1941
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Dallas, TX
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Columbus, Ohio 43210
Principal Investigator: Kari L. Kendra
Phone: 614-366-7421
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Columbus, OH
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Paris,
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10510 North 92nd Street
Scottsdale, Arizona 85251
Principal Investigator: Michael Gordon
Phone: 623-238-7671
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Scottsdale, AZ
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