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NCT05059262 (Vimseltinib in Tenosynovial Giant Cell Tumor): BVCT ex-ante prediction vs. reported outcome

On 23 Aug 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 22 Jun 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

Acronym
MOTION
Drug Name
Vimseltinib (DCC-3014)
Drug MoA
CSF1R inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Tenosynovial Giant Cell Tumor (TGCT)
Human Patients
123
Sponsor
Deciphera Pharmaceuticals
Phase
Phase 3

Prediction of , index 1221

Prospective Prediction
Prediction Index
1221
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit superior to pexidartinib)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
304 days in advance
Readout Data Interpretation
vimseltinib achieved 40% placebo-adjusted ORR at week 25 (p<0.0001), which is numerically superior to 39% placebo-adjusted ORR at week 25 (p<0.0001) achieved by pexidartinib (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official 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)
Phase
Phase 3
Status
Active not recruiting
Enrollment
123
Lead sponsor
Deciphera Pharmaceuticals, LLC
Conditions
Tenosynovial Giant Cell Tumor; Pigmented Villonodular Synovitis; Giant Cell Tumor of Tendon Sheath; Tenosynovial Giant Cell Tumor, Diffuse; Tenosynovial Giant Cell Tumor, Localized
Interventions
DRUG: Vimseltinib; DRUG: Placebo
Design
Randomized · Crossover · Quadruple
Primary purpose
Treatment
Start
2021-10-14
Primary completion
2023-08-10
Completion
2028-07
Results first posted
2025-02-24
Primary outcomes
  • Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (Baseline to Week 25 (Cycle 7, Day 1))

NCT05059262 on ClinicalTrials.gov

How to read these records: evidence · methodology · all trials