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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabrafenib | |||
| Dabrafenib plus Trametinib | Patients treated with Dabrafenib plus Trametinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trametinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Metastasic melanoma patients treated with Dabrafenib +/- Trametinib in compassionate use.
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| Name | Affiliation | Role |
|---|---|---|
| Salvador Martín Algarra, M.D., Ph.D. | Clinica Universidad de Navarra | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Torrecárdenas | Almería | Almería | Spain | |||
| Hospital Universitario Son Espases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29384960 | Result | 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. |
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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 | 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. |
| 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 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C560077 | trametinib |
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