Clinical trial NCT02439411: Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain
Official title: Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma Stage IV
Malignant Melanoma Stage IIIc
Lead sponsor: Grupo Español Multidisciplinar de Melanoma
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2015-05-08
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastasic melanoma patients treated with Dabrafenib +/- Trametinib in compassionate use.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Best Overall Response
timeFrame: Up to 18 months
measure: Adverse Event Rates
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Secondary outcomes:
measure: Overall Survival
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
measure: Resectability of tumor
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
measure: Adherence to treatment
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Complejo Hospitalario Torrecárdenas
state: Almería
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Baleares
city: Badalona
country: Spain
facility: Instituto Catalán de Oncología Badalona/Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Instituto Catalán de Oncología L'Hospitalet
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí de Sabadell
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Donostia
country: Spain
facility: Onkologikoa Fundazioa
state: Guipúzcoa
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular de Canarias
state: Las Palmas
city: Pamplona
country: Spain
facility: Clínica Universidad Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Girona
country: Spain
facility: Instituto Catalán de Oncología Girona/Hospital Universitari Dr. Josep Trueta
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitaria La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Orense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Clinica Universidad de Navarra
name: Salvador Martín Algarra, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Martin Algarra S, Soriano V, Fernandez-Morales L, Berciano-Guerrero MA, Mujika K, Manzano JL, Puertolas Hernandez T, Soria A, Rodriguez-Abreu D, Espinosa Arranz E, Medina Martinez J, Marquez-Rodas I, Rubio-Casadevall J, Ortega ME, Jurado Garcia JM, Lecumberri Biurrun MJ, Palacio I, Rodriguez de la Borbolla Artacho M, Altozano JP, Castellon Rubio VE, Garcia A, Luna P, Ballesteros A, Fernandez O, Lopez Martin JA, Berrocal A, Arance A. Dabrafenib plus trametinib for compassionate use in metastatic melanoma: A STROBE-compliant retrospective observational postauthorization study. Medicine (Baltimore). 2017 Dec;96(52):e9523. doi: 10.1097/MD.0000000000009523.