NCT03798977

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

December 27, 2018

Last Update Submit

February 5, 2024

Conditions

Keywords

Skin metastasisResistanceEndoplasmic reticulum stressMetastasis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with metastatic melanoma

You may qualify if:

  • Patient with metastatic melanoma
  • Not opposition of the patient will have been looked for

You may not qualify if:

  • Primary resistance,
  • Absence of resistance,
  • Patient already included in other trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice hospital

Nice, 06000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

biopsy of a target lesion (skin, lymph node or visceral metastases)

MeSH Terms

Conditions

MelanomaNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2018

First Posted

January 10, 2019

Study Start

February 1, 2018

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations