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

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

sites

James Cancer Hospital & Solove Research Institute-Ohio State

Columbus, Ohio 43210

Principal Investigator: Kari L. Kendra

Phone: 614-366-7421

from

Columbus, OH