Last Update: Jun 25, 2024
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CDRB436X2X02B
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers, High Grade Glioma
Phase4
Recruiting
100
Dec 28, 2017
Dec 21, 2027
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

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)

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.

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals