Dabrafenib and/or Trametinib Rollover Study

Phase 4

Recruiting

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

• Registration Number: NCT03340506
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria:<br><br> - Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or<br> combination within a Novartis or former GSK sponsored study which has fulfilled the<br> requirements for the primary objective.<br><br> - In the opinion of the Investigator would benefit from continued treatment.<br><br>Exclusion Criteria:<br><br> - Patient has been previously permanently discontinued from study treatment in the<br> parent protocol.<br><br> - Patient's indication is commercially available and reimbursed in the local country.<br><br> - Patient currently has unresolved toxicities for which dabrafenib and/or trametinib<br> dosing has been interrupted in the parent study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination

Secondary Outcome Measures

Name	Time	Method
Clinical Benefit Assessment by investigator