Vimseltinib for Tenosynovial Giant Cell Tumor (MOTION)

 

Trial name: Vimseltinib for Tenosynovial Giant Cell Tumor (TGCT), MOTION study
Agents: Vimseltinib vs. placebo
Phase III
Status  Recruiting/open
Sponsor Deciphera Pharmaceuticals

 

This Phase 3 clinical study aims to evaluate the effectiveness of vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. Further information: https://clinicaltrials.gov/ct2/show/NCT05059262

  

WHO is the trial for?

  • Patients ≥18 years of age with confirmed TGCT and for which surgical resection is not an option
  • Symptomatic disease as defined as at least moderate pain or at least moderate stiffness (defined as a score of 4 or more, with 10 describing the worst condition)
  • Excluded are patients who received previous systemic therapy (investigational or approved) with a targeting colony stimulating factor 1 (CSF1) or CSFR1 receptor (CSF1R); previous therapy with imatinib and nilotinib is allowed.

WHAT is the key question that this trial is attempting to answer?

This study assesses the efficacy, safety and tolerability of vimseltinib in patients with unresectable TGCT. Assessed will be response rate, but also range of motion, physical function, quality of life, stiffness and pain.

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in TGCT and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

More about the importance and benefits of joining clinical trials: Please click here.

WHEN will the trial be open?

 The study is open and recruiting.

WHERE is the trial available?

The trial is being conducted in several study centers in the US, Australia, Canada, Netherlands, Poland, Spain, Switzerland and the UK. Further study sites are planned. For further information please check here.

Study contact:

Clinical Team
Phone: +1785-830-2100
Email: clinicaltrials@deciphera.com

STUDY DESIGN: What does the study look like?

There are 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Patients in one group will be assigned to vimseltinib, the other group will receive placebo. 

The study consists of two parts. In Part 1, 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 tumors 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.

Vimseltinib will be given at a dosage of 30 mg twice a week (biw) vimseltinib for 24 weeks in Part 1 and continue on 30 mg biw vimseltinib in Part 2.

HOW do I get more information?

Patient organisations supporting TGCT (or sarcoma) patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients. If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.eu

SHARE your experience

You want to share your experience on this trial?
Send us an e-mail to: info@sarcoma-patients.eu
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

No results are available at this time. Future results will be linked here.

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken

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