Tolerance of Targeted Therapy Used in Metastatic Melanoma in Patients Aged Over 65 and 75-year-old
TOLBRIPA
Safety of Targeted Therapies in Elderly Patients (Over 5 and 75 Year-old) With Metastatic Melanoma
1 other identifier
observational
358
1 country
1
Brief Summary
Since 2013, therapeutic care of metastatic melanoma (MM) has greatly improved, especially thanks to BRAF and MEK targeted therapies. The efficacy of these treatments that are now used daily at first line for BRAF mutated MM is widely approved. Their toxicities, in monotherapy or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell carcinomas, keratoacanthomas, de novo melanomas… However, onco-dermatologists are more and more faced with MM of elderly patients. Indeed, life expectancy continues to increase and the over-75-year-old age group is becoming larger. These patients are still active but much more vulnerable. Nevertheless, there is no data in the literature for this fragile population except the MM pivotal studies subgroups of those over 65-year-old. The results vary with different regimens. Therefore, there is a wide lack of information that could help make a therapeutic decision, inform patients, prevent or treat side effects of BRAF and MEK inhibitors in elderly patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2017
CompletedStudy Start
First participant enrolled
May 5, 2017
CompletedFirst Posted
Study publicly available on registry
May 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedApril 18, 2019
September 1, 2018
1.6 years
May 5, 2017
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
grade 3-4 adverse effects
Analyze the relationship between Grade 3 and Level 4 adverse events in subjects older than 65 or 75 years of age compared to patients under 65 years of age
1 day
Secondary Outcomes (1)
Treatment modification
1 day
Study Arms (3)
patients over 75 years
Patients with MM treated with single or combination therapy over 75 years of age.
patients between 65 and 75 years
Patients aged 65-75 years with MM treated with single or dual therapy
patients less than 65 years
patients less than 65 years with MM treated with single or dual therapy
Eligibility Criteria
More 65 and 75 yo patients, Braf mutated, treated with targeted therapies in mono or bitherapy for metastatic melanoma
You may qualify if:
- Metastatic melanoma
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uhmontpellier
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
ondine BECQUART
University Hospital, Montpellier
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2017
First Posted
May 16, 2017
Study Start
May 5, 2017
Primary Completion
November 30, 2018
Study Completion
December 31, 2018
Last Updated
April 18, 2019
Record last verified: 2018-09