Dabrafenib and/or Trametinib Rollover Study

Novartis

Status and phase: Enrolling; Phase 4

Conditions: Solid Tumor; Melanoma; High Grade Glioma; Non Small Cell Lung Cancer; Rare Cancers

Treatments: Drug: dabrafenib; Drug: trametinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03340506

CDRB436X2X02B

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

dabrafenib monotherapy

Experimental group

Description:

Patients in this study may receive: - monotherapy of dabrafenib

Treatment:

Drug: dabrafenib

trametinib monotherapy

Experimental group

Description:

Patients in this study may receive: - monotherapy of trametinib

Treatment:

Drug: trametinib

Combination therapy (dabrafenib & trametinib)

Experimental group

Description:

Patients in this study may receive: - the combination of dabrafenib and trametinib

Treatment:

Drug: trametinib

Drug: dabrafenib