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

Completed

• Conditions: Malignant Melanoma Stage IV; Malignant Melanoma Stage IIIc
• Interventions: Drug: Trametinib

• Registration Number: NCT02439411
• Lead Sponsor: Grupo Español Multidisciplinar de Melanoma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-03
• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-08
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-29
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dabrafenib plus Trametinib	Trametinib	Patients treated with Dabrafenib plus Trametinib

Primary Outcome Measures

Name	Time	Method
Best Overall Response	Up to 18 months	Participants will be followed for the duration of hospital stay, an expected average of 18 months.
Adverse Event Rates	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 Outcome Measures

Name	Time	Method
Overall Survival	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.
Resectability of tumor	Participants will be followed for the duration of hospital stay, an expected average of 18 months.	Proportion of patients whom tumor was resectable
Adherence to treatment	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

Trial Locations

Locations (29)

Complejo Hospitalario Torrecárdenas; 🇪🇸 Almeria, Almería, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma De Mallorca, Baleares, 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, Guipúzcoa, Spain

Complejo Hospitalario Universitario Insular de Canarias; 🇪🇸 Las Palmas de Gran Canaria, Las Palmas, Spain

Clínica Universidad Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Scroll for more (19 remaining)