Study of Vimseltinib for Tenosynovial Giant Cell Tumour

Titre officiel

A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumour (MOTION)

Sommaire:

This is a multicentre Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumour (TGCT) in cases where surgical removal of the tumour is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumours to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.

Description de l'essai

Primary Outcome:

• Objective Response Rate (ORR= complete response [CR]+partial response [PR]) per RECIST Version 1,1

• ORR per Tumour Volume Score (TVS)
• Range of motion (ROM)
• Physical function
• Worst stiffness
• Quality of life (QoL)
• Worst pain

Voir cet essai sur ClinicalTrials.gov