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Completed

NCT Number: NCT02439411

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

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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Key information

Conditions

Malignant Melanoma Stage IV Malignant Melanoma Stage IIIc Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Torrecárdenas, Almería, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trametinib

Drug

Primary outcomes

  1. Best Overall Response

    Time frame: Up to 18 months

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

  2. Adverse Event Rates

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

    Percentage of patients developing an Adverse Event through follow-up

Secondary outcomes

  1. Overall Survival

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

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

  2. Resectability of tumor

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

    Proportion of patients whom tumor was resectable

  3. Adherence to treatment

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

    Proportion of patients who comply with treatment as prescribed

Sponsors and collaborators

Lead sponsor

Grupo Español Multidisciplinar de Melanoma

Other

Collaborators

  • GlaxoSmithKline

Registry information

Acronym: DEIS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 8, 2015
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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