Study identification

PURI

https://redirect.ema.europa.eu/resource/36726

EU PAS number

EUPAS28059

Study ID

36726

Official title and acronym

Retrospective analysis of safety in elderly metastatic or unresectable BRAF V600 melanoma patients treated with Tafinlar (dabrafenib) plus Mekinist (trametinib) and correlation with clinical features and non-elderly patients

DARWIN EU® study

No

Study countries

Spain

Study description

The purpose of this study is to define the real-world care of elderly metastatic or unresectable BRAF V600 melanoma patients treated with dabrafenib and trametinib in Spain, and provide more data regarding safety in this population. The secondary endpoints will also analyze potential confounding factors, as well as exploratory differences on efficacy. This is a non-interventional, national and purely retrospective study based on secondary use of data from individual medical records to evaluate the safety and real-world management of dabrafenib or combination with trametinib in elderly and non-elderly patients with metastatic or unresectable BRAF V600 melanomaThe study includes a selection period of 7 months and a single visit aimed at obtaining the informed consent of patients (when the patient is alive), which will coincide with one of those regularly conducted by patients over their routine follow-up, without interfering with the investigator’ clinical practice.

Study status

Finalised
Research institutions and networks

Institutions

Hospital Universitario de Torrecardenas Almeria, Hospital Virgen de la Salud, Toledo Toledo, Hospital Nuestra Señora de la Candelaria Santa Cruz de Teneirife, ICO Badalona (Hospital Germans Trias i Pujol) Badalona (Barcelona), Hospital de la Santa Creu i Sant Pau Barcelona, Hospital Universitario Central de Asturias Oviedo, Onkologikoa San Sebastian, Hospital Universitario Marqués de Valdecilla Santander, Hospital Clínico de Valencia Valencia, Hospital Clínico San Carlos Madrid

Contact details

Novartis Clinical Disclosure Officer

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis Farmaceutica, S.A
Study protocol
Initial protocol

CDRB436BES04_11Jan2019_FINAL_Redacted

English (598.06 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable