Trials / Recruiting
RecruitingNCT03340506
Dabrafenib and/or Trametinib Rollover Study
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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dabrafenib | dabrafenib is available in capsules (50mg and 75mg) taken twice a day |
| DRUG | trametinib | trametinib is available in tablets (0.5mg, 2mg dose) |
Timeline
- Start date
- 2017-12-28
- Primary completion
- 2032-12-28
- Completion
- 2032-12-28
- First posted
- 2017-11-13
- Last updated
- 2026-04-01
Locations
28 sites across 12 countries: United States, Argentina, Austria, China, Denmark, France, Germany, Hungary, Japan, Netherlands, Spain, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03340506. Inclusion in this directory is not an endorsement.