Malignant Melanoma Stage IVDEISNCT02439411
Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain
An observational study of Malignant Melanoma Stage IV and Malignant Melanoma Stage IIIc, run by Grupo Español Multidisciplinar de Melanoma at 29 sites in Spain.
Trial summary
The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma Stage IV, Malignant Melanoma Stage IIIc
- What is being tested?
- Trametinib
- How many people
- 135 participants
- Where
- 29 sitesSpain
- Study dates
- 3 Mar 2015to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metastasic melanoma patients treated with Dabrafenib +/- Trametinib in compassionate use.
Who may be able to join
- 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.
Who cannot join
- Patients with a history not available.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Spain29 sites
Complejo Hospitalario Torrecárdenas
Almería, Almería
Instituto Catalán de Oncología Badalona/Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona
Hospital Clínic de Barcelona
Barcelona
Onkologikoa Fundazioa
Donostia / San Sebastian, Guipúzcoa
Hospital General Universitario de Elche
Elche
Instituto Catalán de Oncología Girona/Hospital Universitari Dr. Josep Trueta
Girona
Hospital Universitario San Cecilio
Granada
Instituto Catalán de Oncología L'Hospitalet
L'Hospitalet de Llobregat, Barcelona
Complejo Hospitalario Universitario Insular de Canarias
Las Palmas de Gran Canaria, Las Palmas
Hospital Universitari Arnau de Vilanova
Lleida
Hospital 12 de Octubre
Madrid
Hospital Universitaria La Princesa
Madrid
Hospital Universitario Gregorio Marañón
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Regional Universitario de Málaga
Málaga
Complexo Hospitalario Universitario de Ourense
Ourense
Hospital Universitario Central de Asturias
Oviedo
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands
Clínica Universidad Navarra
Pamplona, Navarre
Hospital Universitario de Navarra
Pamplona, Navarre
Corporació Sanitaria Parc Taulí de Sabadell
Sabadell, Barcelona
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
Hospital Universitario de Valme
Seville
Hospital Virgen de la Salud
Toledo
Hospital Clínico Universitario de Valencia
Valencia
Hospital General Universitario de Valencia
Valencia
Instituto Valenciano de Oncología
Valencia
Hospital Miguel Servet
Zaragoza
About this study
The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs.
- Being tested
- Trametinib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrametinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabrafenib | Not described | |
| Dabrafenib plus Trametinib | Patients treated with Dabrafenib plus Trametinib Receives: Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response
Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Measured: Up to 18 months
Adverse Event Rates
Percentage of patients developing an Adverse Event through follow-up
Measured: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Secondary outcomes (3)
Overall Survival
Number of patients alive at the end of the follow-up period and median time between start of treatment and death.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Resectability of tumor
Proportion of patients whom tumor was resectable
Measured: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Adherence to treatment
Proportion of patients who comply with treatment as prescribed
Measured: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start3 Mar 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Melanoma Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español Multidisciplinar de Melanoma
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Salvador Martín Algarra, M.D., Ph.D., Study chair, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439411
- Sponsor's protocol ID
- GEM1401
- Acronym
- DEIS
- Status last verified
- Nov 2019
- First submitted
- 30 Apr 2015
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29384960
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain
- ClinicalTrials.gov ID
- NCT02439411
- Acronym / sponsor ID
- DEIS / GEM1401
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Grupo Español Multidisciplinar de MelanomaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 3 Mar 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabrafenib | – | – |
| Dabrafenib plus Trametinib | – | Drug: TrametinibPatients treated with Dabrafenib plus Trametinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastasic melanoma patients treated with Dabrafenib +/- Trametinib in compassionate use.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with a history not available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trametinib | Drug | Dabrafenib plus Trametinib |
Primary outcome
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.
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
3 secondary outcomes
Overall Survival
Time frame: 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.
Adherence to treatment
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Results publication: PubMed 29384960Martin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvador Martín Algarra, M.D., Ph.D. study chair
Clinica Universidad de Navarra
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Melanoma Stage IV and Malignant Melanoma Stage IIIc, run by Grupo Español Multidisciplinar de Melanoma at 29 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response (time frame: Up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02439411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.