Dabrafenib and/or Trametinib Rollover Study
Melanoma · Non Small Cell Lung Cancer · Solid Tumor · Rare Cancers · High Grade Glioma
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 4
- Age range
- 18 years - 100 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 100 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
dabrafenib monotherapy
Patients in this study may receive:
\- monotherapy of dabrafenib
Drug: dabrafenib
trametinib monotherapy
Patients in this study may receive:
\- monotherapy of trametinib
Drug: trametinib
Combination therapy (dabrafenib & trametinib)
Patients in this study may receive:
\- the combination of dabrafenib and trametinib
Drug: dabrafenib · Drug: trametinib
dabrafenib DRUG
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
trametinib DRUG
trametinib is available in tablets (0.5mg, 2mg dose)
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
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.
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 measures
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.
To evaluate clinical benefit as assessed by the Investigator
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (37)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
37 locations
Honor Health Research InstituteScottsdale, Arizona, United StatesActive, not recruiting
National Institute Of HealthBethesda, Maryland, United StatesActive, not recruiting
James Cancer Hospital and Solove Research Institute Ohio StateColumbus, Ohio, United StatesCompleted
Mary Crowley Cancer ResearchDallas, Texas, United StatesCompleted
Novartis Investigative SiteCaba, Buenos Aires, ArgentinaCompleted
Novartis Investigative SiteInnsbruck, Tyrol, AustriaActive, not recruiting
Novartis Investigative SiteToronto, Ontario, CanadaRecruiting
Novartis Investigative SiteBeijing, ChinaCompleted
Novartis Investigative SiteBrno, CzechiaActive, not recruiting
Novartis Investigative SitePrague, CzechiaActive, not recruiting
Novartis Investigative SiteCopenhagen, DenmarkActive, not recruiting
Novartis Investigative SiteLyon, FranceActive, not recruiting
Novartis Investigative SiteNantes, FranceCompleted
Novartis Investigative SiteParis, FranceActive, not recruiting
Novartis Investigative SiteParis, FranceCompleted
Novartis Investigative SiteVillejuif, FranceRecruiting
Novartis Investigative SiteMannheim, Baden-Wurttemberg, GermanyCompleted
Novartis Investigative SiteAugsburg, GermanyActive, not recruiting
Novartis Investigative SiteBerlin, GermanyCompleted
Novartis Investigative SiteEssen, GermanyActive, not recruiting
Novartis Investigative SiteHamburg, GermanyCompleted
Novartis Investigative SiteHamburg, GermanyActive, not recruiting
Novartis Investigative SiteHeidelberg, GermanyActive, not recruiting
Novartis Investigative SiteDebrecen, Hajdu Bihar Megye, HungaryCompleted
Novartis Investigative SiteBudapest, HungaryCompleted
Novartis Investigative SiteKashiwa, Chiba, JapanCompleted
Novartis Investigative SiteChuo Ku, Tokyo, JapanCompleted
Novartis Investigative SiteRotterdam, South Holland, NetherlandsCompleted
Novartis Investigative SiteUtrecht, NetherlandsActive, not recruiting
Novartis Investigative SiteMoscow, RussiaActive, not recruiting
Novartis Investigative SiteBarcelona, SpainRecruiting
Novartis Investigative SiteMadrid, SpainActive, not recruiting
Novartis Investigative SiteMadrid, SpainRecruiting
Novartis Investigative SiteMadrid, SpainCompleted
Novartis Investigative SiteMadrid, SpainRecruiting
Novartis Investigative SiteValencia, SpainActive, not recruiting
Novartis Investigative SiteSongkhla, Hat Yai, ThailandActive, not recruiting
Study team and timeline
- Lead sponsor
- Novartis Pharmaceuticals
- Study start
- Jan 26, 2018 Actual
- Primary completion
- Dec 28, 2032 Estimated
- Study completion
- Dec 28, 2032 Estimated
- First posted
- Nov 13, 2017 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
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
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026