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RecruitingInterventionalPhase 4

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

NCT ID: NCT03340506Sponsor: Novartis PharmaceuticalsLast updated: 2026-06-10

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.

Arms & interventions

  • Drugdabrafenib

    dabrafenib is available in capsules (50mg and 75mg) taken twice a day

  • Drugtrametinib

    trametinib is available in tablets (0.5mg, 2mg dose)

Outcome measures

Primary

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

    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.

    Time frame: 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.

Secondary

  • Clinical Benefit Assessment by investigator

    Time frame: 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.

Eligibility criteria

Sex: AllAge: 18 Years to 100 YearsHealthy volunteers: No
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 locations (5)

Honor Health Research Institute

Scottsdale, Arizona, 85258

Active Not Recruiting

Honor Health Research Institute

Scottsdale, Arizona, 85258

Recruiting
Michael Gordon · Principal Investigator

National Institute Of Health

Bethesda, Maryland, 20892

Active Not Recruiting

James Cancer Hospital and Solove Research Institute Ohio State

Columbus, Ohio, 43210

Completed

Mary Crowley Cancer Research

Dallas, Texas, 75251

Completed