Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain (DEIS)
November 29, 2019 updated by: Grupo Español Multidisciplinar de Melanoma
The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
135
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain
- Hospital Clínic de Barcelona
-
Elche, Spain
- Hospital General Universitario de Elche
-
Girona, Spain
- Instituto Catalán de Oncología Girona/Hospital Universitari Dr. Josep Trueta
-
Granada, Spain
- Hospital Universitario San Cecilio
-
Lleida, Spain
- Hospital Universitari Arnau de Vilanova
-
Madrid, Spain
- Hospital 12 De Octubre
-
Madrid, Spain
- Hospital Universitario La Paz
-
Madrid, Spain
- Hospital Universitario Ramón y Cajal
-
Madrid, Spain
- Hospital Universitario Gregorio Marañón
-
Madrid, Spain
- Hospital Universitaria La Princesa
-
Málaga, Spain
- Hospital Regional Universitario de Malaga
-
Orense, Spain
- Complexo Hospitalario Universitario de Ourense
-
Oviedo, Spain
- Hospital Universitario Central de Asturias
-
Sevilla, Spain
- Hospital Universitario de Valme
-
Toledo, Spain
- Hospital Virgen de la Salud
-
Valencia, Spain
- Instituto Valenciano de Oncología
-
Valencia, Spain
- Hospital Clínico Universitario de Valencia
-
Valencia, Spain
- Hospital General Universitario de Valencia
-
Zaragoza, Spain
- Hospital Miguel Servet
-
-
Almería
-
Almeria, Almería, Spain
- Complejo Hospitalario Torrecárdenas
-
-
Baleares
-
Palma De Mallorca, Baleares, Spain
- Hospital Universitario Son Espases
-
-
Barcelona
-
Badalona, Barcelona, Spain
- Instituto Catalán de Oncología Badalona/Hospital Universitari Germans Trias i Pujol
-
L'Hospitalet De Llobregat, Barcelona, Spain
- Instituto Catalán de Oncología L'Hospitalet
-
Sabadell, Barcelona, Spain
- Corporació Sanitària Parc Taulí de Sabadell
-
-
Cantabria
-
Santander, Cantabria, Spain
- Hospital Universitario Marqués de Valdecilla
-
-
Guipúzcoa
-
Donostia, Guipúzcoa, Spain
- Onkologikoa Fundazioa
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spain
- Complejo Hospitalario Universitario Insular de Canarias
-
-
Navarra
-
Pamplona, Navarra, Spain
- Clinica Universidad Navarra
-
Pamplona, Navarra, Spain
- Hospital Universitario de Navarra
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Metastasic melanoma patients treated with Dabrafenib +/- Trametinib in compassionate use.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Dabrafenib
|
|
|
Dabrafenib plus Trametinib
Patients treated with Dabrafenib plus Trametinib
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Best Overall Response
Time Frame: Up to 18 months
|
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
|
Up to 18 months
|
|
Adverse Event Rates
Time Frame: 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
|
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: 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.
|
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
|
|
Resectability of tumor
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
|
Proportion of patients whom tumor was resectable
|
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
|
|
Adherence to treatment
Time Frame: 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
|
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Salvador Martín Algarra, M.D., Ph.D., Clinica Universidad de Navarra
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
April 30, 2015
First Submitted That Met QC Criteria
May 6, 2015
First Posted (Estimate)
May 8, 2015
Study Record Updates
Last Update Posted (Actual)
December 2, 2019
Last Update Submitted That Met QC Criteria
November 29, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEM1401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.