MOTION
Research type
Research Study
Full title
A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor (MOTION)
IRAS ID
296461
Contact name
Sophie Higgins
Contact email
Sponsor organisation
Deciphera Pharmaceuticals, LLC
Eudract number
2020-004883-25
Clinicaltrials.gov Identifier
131218, IND Number
Duration of Study in the UK
5 years, 9 months, 30 days
Research summary
The safety and effects of taking vimseltinib (study medicine) compared to placebo, for participants with Tenosynovial Giant Cell Tumour (TGCT), will be studied in this Clinical Trial. 120 participants, 18 years of age and older from Europe, North America and Asia Pacific will take part.
The Trial is divided into the below phases:
• Screening
• Part 1 (double blinded phase) – In this phase, participants will have a 2 out of 3 chance of receiving vimseltinib, based on a random computer assignment.
• Part 2 (open label phase) – In this phase, all participants will receive vimseltinib and will include the crossover participants from Part 1, that had not been receiving vimseltinib.
• Extension to treatment period and
• Follow-up (for Safety and Disease follow-up)Participation will be of a minimum of about 7.5 months but can be much longer, if participants choose to continue onto Part 2 of the study and after the extension period. Participation is voluntary.
The study medicine comes as capsules which will need to be taken orally twice a week. The maximum dose a participant can receive is 30mg of vimseltinib. Side effects will be monitored throughout the study.
Vimseltinib will be given to participants during this study, until or if the participants disease progresses, an unacceptable side effect occurs, participants withdraw their consent, vimseltinib becomes approved and commercially available in UK or the study is closed.
Participants will be expected to attend clinic visits whereby study assessments will take place e.g. routine (safety) blood and urine tests, body scan of the affected joint/s, physical examination, vital signs and completion of questionnaires.
REC name
Wales REC 2
REC reference
21/WA/0241
Date of REC Opinion
13 Aug 2021
REC opinion
Favourable Opinion