Malignant Melanoma Stage IIIc, Malignant Melanoma Stage IV
Conditions
Brief summary
The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs.
Interventions
DRUGTrametinib
Sponsors
GlaxoSmithKline
Grupo Español Multidisciplinar de Melanoma
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have received at least one dose of dabrafenib or combination with trametinib as part of a compassionate use for the treatment of metastatic melanoma, with deadline the start of treatment the April 30, 2014.
Exclusion criteria
* Patients with a history not available.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response | Up to 18 months | Participants will be followed for the duration of hospital stay, an expected average of 18 months. |
| Adverse Event Rates | Participants will be followed for the duration of hospital stay, an expected average of 18 months. | Percentage of patients developing an Adverse Event through follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Participants will be followed for the duration of hospital stay, an expected average of 18 months. | Number of patients alive at the end of the follow-up period and median time between start of treatment and death. |
| Resectability of tumor | Participants will be followed for the duration of hospital stay, an expected average of 18 months. | Proportion of patients whom tumor was resectable |
| Adherence to treatment | Participants will be followed for the duration of hospital stay, an expected average of 18 months. | Proportion of patients who comply with treatment as prescribed |
Countries
Spain
Outcome results
None listed