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

Conditions

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

  • Spain
      • Barcelona, Spain
        • Hospital Clinic 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 Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario Gregorio Maranon
      • 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 Oncologia
      • Valencia, Spain
        • Hospital Clinico 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 Marques 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
Drug: 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.

Sponsor

Grupo Español Multidisciplinar de Melanoma

Collaborators

GlaxoSmithKline

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.

General Publications

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.

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