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

Grupo Español Multidisciplinar de Melanoma135 enrolled

Overview

The purpose of this study is to analyze whether Dabrafenib +/- Trametinib are effective in overall survival, response rates and toxicity in both programs.

Study Type

OBSERVATIONAL

Enrollment

135

Conditions

Malignant Melanoma Stage IV Malignant Melanoma Stage IIIc

Interventions

TrametinibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (29)

Outcomes

Primary Outcomes

Best Overall Response

Participants will be followed for the duration of hospital stay, an expected average of 18 months.

Time frame: Up to 18 months

Adverse Event Rates

Percentage of patients developing an Adverse Event through follow-up

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.

Secondary Outcomes

Overall Survival

Number of patients alive at the end of the follow-up period and median time between start of treatment and death.

Time frame: 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

Time frame: 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

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Complejo Hospitalario Torrecárdenas

Almería, Almería, Spain

Hospital Universitario Son Espases

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

...and 19 more locations