Overview

This trial is active, not recruiting.

Conditions malignant melanoma stage iv, malignant melanoma stage iiic
Treatment trametinib
Target MEK
Sponsor Grupo Español Multidisciplinar de Melanoma
Collaborator GlaxoSmithKline
Start date January 2015
End date November 2016
Trial size 120 participants
Trial identifier NCT02439411, GEM1401

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients treated with Dabrafenib plus Trametinib
trametinib

Primary Outcomes

Measure
Evaluate the best overall response of each patient
time frame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Adverse Event rates
time frame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.

Secondary Outcomes

Measure
Overall Survival
time frame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Resectability of tumor
time frame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Adherence to treatment
time frame: Participants will be followed for the duration of hospital stay, an expected average of 18 months.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Retrospective Analysis of Dabrafenib +/- Trametinib Compassionate Use Experience in Spain
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Grupo Español Multidisciplinar de Melanoma.