Dabrafenib and/or Trametinib Rollover Study

Phase 4

Recruiting

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

• Registration Number: NCT03340506
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2017-12-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2027-12-20
• Study Completion: 2027-12-21

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dabrafenib monotherapy	dabrafenib	Patients in this study may receive: - monotherapy of dabrafenib
trametinib monotherapy	trametinib	Patients in this study may receive: - monotherapy of trametinib
Combination therapy (dabrafenib & trametinib)	dabrafenib	Patients in this study may receive: - the combination of dabrafenib and trametinib
Combination therapy (dabrafenib & trametinib)	trametinib	Patients in this study may receive: - the combination of dabrafenib and trametinib

Primary Outcome Measures

Name	Time	Method
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination	Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.	Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.

Secondary Outcome Measures

Name	Time	Method
Clinical Benefit Assessment by investigator	Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.	To evaluate clinical benefit as assessed by the Investigator

Trial Locations

Locations (5)

Honor Health Research Institute; 🇺🇸 Scottsdale, Arizona, United States

National Institute Of Health; 🇺🇸 Bethesda, Maryland, United States

James Cancer Hospital and Solove Research Institute Ohio State; 🇺🇸 Columbus, Ohio, United States

Mary Crowley Cancer Research; 🇺🇸 Dallas, Texas, United States

Novartis Investigative Site; 🇹🇭 Songkhla, Hat Yai, Thailand