Preclinical Validation of New Anti-melanoma Compounds

Melanoma Clinical Trial

— ERMELATHER  

Official title:

Preclinical Validation of New Anti-melanoma Compounds: Study on Patient Melanoma Cells Sensitive and Resistant to BRAF/MEK Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798977
• Other study ID #: 17-PRTK-01
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research program is in keeping with the chemistry/biology/clinical interface and gathers 4 teams with complementary expertise in these respective fields. It will allow deciphering the mechanism(s) of action of new Thiazole-Benzenesulfonamide family (TZB) derivatives on metastatic melanoma sensitive and resistant to BRAF and MEK inhibitors. Investigators will use melanoma cell lines and primary cells from patients to validate these compounds in collaboration with clinical team 2 and 4. In conclusion, the investigators expect to establish the proof of concept that this new class of bioactive molecules (first in class) we developed in collaboration with Team 3 have the potential to go to the clinic for the treatment of highly aggressive cancers and particularly metastatic melanoma sensitive and resistant B-Raf and MEK inhibitors. Furthermore, the realization of this project can undoubtedly increase the knowledge of mechanisms and signaling pathways that are involved in resistant to BRAF and MEK inhibitors, and allow the selection of drug candidates capable of restoring the sensitivity of these melanoma cells.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with metastatic melanoma

• Not opposition of the patient will have been looked for

Exclusion Criteria:

• Primary resistance,

• Absence of resistance,

• Patient already included in other trials

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
France	Nice hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BRAF mutation	The status of the BRAF mutation will be expressed through laboratory analysis of the samples collected, i.e. positive or negative.	24 months