Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain
DEIS
1 other identifier
observational
135
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2015
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2015
CompletedFirst Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedDecember 2, 2019
November 1, 2019
1.5 years
April 30, 2015
November 29, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Best Overall Response
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Up to 18 months
Adverse Event Rates
Percentage of patients developing an Adverse Event through follow-up
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Secondary Outcomes (3)
Overall Survival
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Resectability of tumor
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Adherence to treatment
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Study Arms (2)
Dabrafenib
Dabrafenib plus Trametinib
Patients treated with Dabrafenib plus Trametinib
Interventions
Eligibility Criteria
Metastasic melanoma patients treated with Dabrafenib +/- Trametinib in compassionate use.
You may qualify if:
- 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.
You may not qualify if:
- Patients with a history not available.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grupo Español Multidisciplinar de Melanomalead
- GlaxoSmithKlinecollaborator
Study Sites (29)
Complejo Hospitalario Torrecárdenas
Almería, Almería, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Instituto Catalán de Oncología Badalona/Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Instituto Catalán de Oncología L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Corporació Sanitaria Parc Taulí de Sabadell
Sabadell, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Onkologikoa Fundazioa
Donostia / San Sebastian, Guipúzcoa, Spain
Complejo Hospitalario Universitario Insular de Canarias
Las Palmas de Gran Canaria, Las Palmas, Spain
Clínica Universidad Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital General Universitario de Elche
Elche, Spain
Instituto Catalán de Oncología Girona/Hospital Universitari Dr. Josep Trueta
Girona, Spain
Hospital Universitario San Cecilio
Granada, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Universitaria La Princesa
Madrid, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario de Valme
Seville, Spain
Hospital Virgen de la Salud
Toledo, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Instituto Valenciano de Oncología
Valencia, Spain
Hospital Miguel Servet
Zaragoza, Spain
Related Publications (1)
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.
PMID: 29384960RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Salvador Martín Algarra, M.D., Ph.D.
Clinica Universidad de Navarra
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2015
First Posted
May 8, 2015
Study Start
March 3, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
December 2, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share