Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain
- Conditions
- Malignant Melanoma Stage IVMalignant Melanoma Stage IIIc
- Interventions
- Registration Number
- NCT02439411
- Lead Sponsor
- Grupo Español Multidisciplinar de Melanoma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
- 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.
- Patients with a history not available.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dabrafenib plus Trametinib Trametinib Patients treated with Dabrafenib plus Trametinib
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (29)
Hospital Universitario Son Espases
🇪🇸Palma De Mallorca, Baleares, Spain
Hospital Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Instituto Catalán de Oncología Badalona/Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Spain
Complejo Hospitalario Torrecárdenas
🇪🇸Almeria, Almería, Spain
Instituto Catalán de Oncología L'Hospitalet
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Instituto Catalán de Oncología Girona/Hospital Universitari Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Navarra, Spain
Onkologikoa Fundazioa
🇪🇸Donostia, Guipúzcoa, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Complexo Hospitalario Universitario de Ourense
🇪🇸Orense, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Corporació Sanitaria Parc Taulí de Sabadell
🇪🇸Sabadell, Barcelona, Spain
Complejo Hospitalario Universitario Insular de Canarias
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitaria La Princesa
🇪🇸Madrid, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Hospital Universitario de Valme
🇪🇸Sevilla, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Clínica Universidad Navarra
🇪🇸Pamplona, Navarra, Spain