Clinical trial · Observational
Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain
NCT02439411CI-TRIAL-00042003DEIScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Dabrafenib
- label
- Dabrafenib plus Trametinib
- description
- Patients treated with Dabrafenib plus Trametinib
- interventionNames
- Drug: Trametinib
Primary outcomes (2)
- measure
- Best Overall Response
- timeFrame
- Up to 18 months
- description
- Participants will be followed for the duration of hospital stay, an expected average of 18 months.
- measure
- Adverse Event Rates
- timeFrame
- Participants will be followed for the duration of hospital stay, an expected average of 18 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTMartin 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 29384960