Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain

Malignant Melanoma Stage IV Clinical Trial

— DEIS  

Official title:

Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439411
• Other study ID #: GEM1401
• Status: Completed
• Start date: March 3, 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2019
• Source: Grupo Español Multidisciplinar de Melanoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Melanoma Stage IIIc
• Malignant Melanoma Stage IV
• Melanoma

Intervention

Drug:
• Trametinib

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Torrecárdenas	Almeria	Almería
Spain	Instituto Catalán de Oncología Badalona/Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Onkologikoa Fundazioa	Donostia	Guipúzcoa
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	Instituto Catalán de Oncología L'Hospitalet	L'Hospitalet De Llobregat	Barcelona
Spain	Complejo Hospitalario Universitario Insular de Canarias	Las Palmas de Gran Canaria	Las Palmas
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	Orense
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Baleares
Spain	Clínica Universidad Navarra	Pamplona	Navarra
Spain	Hospital Universitario de Navarra	Pamplona	Navarra
Spain	Corporació Sanitaria Parc Taulí de Sabadell	Sabadell	Barcelona
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario de Valme	Sevilla
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

Sponsors (2)

Lead Sponsor	Collaborator
Grupo Español Multidisciplinar de Melanoma	GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Martín Algarra S, Soriano V, Fernández-Morales L, Berciano-Guerrero MÁ, Mujika K, Manzano JL, Puértolas Hernández T, Soria A, Rodríguez-Abreu D, Espinosa Arranz E, Medina Martínez J, Márquez-Rodas I, Rubió-Casadevall J, Ortega ME, Jurado García JM, Lecumb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Response	Participants will be followed for the duration of hospital stay, an expected average of 18 months.	Up to 18 months
Primary	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.
Secondary	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.
Secondary	Resectability of tumor	Proportion of patients whom tumor was resectable	Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Secondary	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.