trametinib for Melanoma

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Melanoma+4 Moretrametinib - Drug
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to provide access for patients who have completed a Novartis or former GSK-sponsored study and are judged by the investigator as benefiting from continued treatment.

Eligible Conditions
  • Melanoma
  • Solid Tumors
  • Brain Tumor
  • Non-Small Cell Lung Cancer
  • Rare Cancers

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 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.

Year 10
Clinical Benefit Assessment by investigator
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

trametinib monotherapy
1 of 3
Combination therapy (dabrafenib & trametinib)
1 of 3
dabrafenib monotherapy
1 of 3

Experimental Treatment

100 Total Participants · 3 Treatment Groups

Primary Treatment: trametinib · No Placebo Group · Phase 4

trametinib monotherapy
Drug
Experimental Group · 1 Intervention: trametinib · Intervention Types: Drug
Combination therapy (dabrafenib & trametinib)Experimental Group · 2 Interventions: trametinib, dabrafenib · Intervention Types: Drug, Drug
dabrafenib monotherapy
Drug
Experimental Group · 1 Intervention: dabrafenib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
FDA approved
Dabrafenib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,718 Previous Clinical Trials
3,524,919 Total Patients Enrolled
44 Trials studying Melanoma
9,571 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18 - 100 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient is currently being treated with dabrafenib and trametinib as a monotherapy or combination therapy within a study sponsored by Novartis or former GSK
The Investigator believes that the person would benefit from continued treatment.