Trial · NCT05059262
Study of Vimseltinib for Tenosynovial Giant Cell Tumor
NCT05059262, Phase 3, Active not recruiting, Deciphera Pharmaceuticals, LLC; results first posted 2025-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Vimseltinib for Tenosynovial Giant Cell Tumor. Trials, record NCT05059262. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05059262
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Vimseltinib for Tenosynovial Giant Cell Tumor
- NCT number
- NCT05059262
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 123 participants, actual
- 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
- Vimseltinib, Placebo
- First posted
- 2021-09-28
- Last updated
- 2026-03-20
- Results first posted
- 2025-02-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | ORR was assessed by blinded independent radiologic review (IRR) using RECIST Version 1.1. ORR was defined as the percentage of participants who achieved either complete response (CR) or partial response (PR). * CR: Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in short axis. Non-nodal targets must be absent. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | ORR at Week 25 Per Tumor Volume Score (TVS) | Baseline to Week 25 (Cycle 7, Day 1) | TVS is a semi-quantitative magnetic resonance imaging (MRI) scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. ORR was the percentage of participants who achieved either CR or PR as assessed by blinded IRR using TVS. * CR: Lesion completely gone * PR: ≥50% decrease in volume score relative to Baseline. |
| Secondary | Change From Baseline in Active Range of Motion (ROM) at Week 25 | Baseline to Week 25 (Cycle 7, Day 1) | Presented here is the change from baseline in active ROM to Week 25. Measurement of the affected and contralateral, non-affected joint was assessed by goniometer and measured in degrees. At baseline, the motion with the smallest relative ROM value (worst) was identified, and this motion was used for evaluating the change in relative ROM subsequently. The affected joint measurement was used to derive a relative ROM based on active measurement relative to reference standard value provided by the American Medical Association. Relative ROM is expressed in percent: 100 x (joint ROM measure)/(reference ROM standard). |
| Secondary | Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25 | Baseline to Week 25 (Cycle 7, Day 1) | All participants were asked 15 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." Total scores were converted to T-scores that ranged from 0 to 100, with higher scores representing less physical function interference and better health outcomes. |
| Secondary | Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25 | Baseline to Week 25 (Cycle 7, Day 1) | The Worst Stiffness NRS is a single question that asks the participant to assess their worst stiffness in the last 24 hours. Participants rate their worst stiffness on a scale of 0 to 10, where 0 is "no stiffness" and 10 is "worst imaginable." Lower scores represented better level of stiffness. |
| Secondary | Change From Baseline in EuroQoL Visual Analogue Scale (EQ-VAS) at Week 25 | Baseline to Week 25 (Cycle 7, Day 1) | The EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical VAS scale ranging from a minimum of 0 (worst imaginable health state) to a maximum of 100 (best imaginable health state). Higher scores indicated better health state. |
| Secondary | Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use | Baseline to Week 25 (Cycle 7, Day 1) | Participants reported responses to the BPI Worst Pain NRS. The BPI Worst Pain NRS ranged from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine." A responder was defined as a participant who: (i) experienced a decrease of at least 30% in the mean BPI Worst Pain NRS item and (ii) did not experience a 30% or greater increase in narcotic analgesic use. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | The ITT Set consisted of participants who were randomized to a study treatment regimen. | percentage of participants with CR or PR | NUMBER |
| SECONDARY | ORR at Week 25 Per Tumor Volume Score (TVS) | Baseline to Week 25 (Cycle 7, Day 1) | The ITT Set consisted of participants who were randomized to a study treatment regimen. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Active Range of Motion (ROM) at Week 25 | Baseline to Week 25 (Cycle 7, Day 1) | The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure at the specified time point. | Change in percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25 | Baseline to Week 25 (Cycle 7, Day 1) | The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure at the specified time point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25 | Baseline to Week 25 (Cycle 7, Day 1) | The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure at the specified time point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EuroQoL Visual Analogue Scale (EQ-VAS) at Week 25 | Baseline to Week 25 (Cycle 7, Day 1) | The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure at the specified time point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use | Baseline to Week 25 (Cycle 7, Day 1) | The ITT Set consisted of participants who were randomized to a study treatment regimen. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Vimseltinib | 39.8 | 95% Confidence Interval 29.2 to 51.1 | percentage of participants with CR or PR | |
| Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | Placebo | 0 | 95% Confidence Interval 0.0 to 8.8 | percentage of participants with CR or PR | |
| ORR at Week 25 Per Tumor Volume Score (TVS) | Vimseltinib | 67.5 | 95% Confidence Interval 56.3 to 77.4 | percentage of participants | |
| ORR at Week 25 Per Tumor Volume Score (TVS) | Placebo | 0 | 95% Confidence Interval 0.0 to 8.8 | percentage of participants | |
| Change From Baseline in Active Range of Motion (ROM) at Week 25 | Vimseltinib | 18.4 | Standard Error 6.46 | Change in percent | |
| Change From Baseline in Active Range of Motion (ROM) at Week 25 | Placebo | 3.8 | Standard Error 7.19 | Change in percent | |
| Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25 | Vimseltinib | 4.6 | Standard Error 0.96 | score on a scale | |
| Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25 | Placebo | 1.3 | Standard Error 0.88 | score on a scale | |
| Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25 | Vimseltinib | -2.1 | Standard Error 0.24 | score on a scale | |
| Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25 | Placebo | -0.3 | Standard Error 0.28 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: Double Blind (Weeks 1 - 24) | STARTED | Part 1/Part 2: Vimseltinib/Vimseltinib | 83 | |
| Part 1: Double Blind (Weeks 1 - 24) | STARTED | Part 1/Part 2: Placebo/Vimseltinib | 40 | |
| Part 1: Double Blind (Weeks 1 - 24) | Received at Least 1 Dose of Study Drug | Part 1/Part 2: Vimseltinib/Vimseltinib | 83 | |
| Part 1: Double Blind (Weeks 1 - 24) | Received at Least 1 Dose of Study Drug | Part 1/Part 2: Placebo/Vimseltinib | 39 | |
| Part 1: Double Blind (Weeks 1 - 24) | COMPLETED | Part 1/Part 2: Vimseltinib/Vimseltinib | 75 | |
| Part 1: Double Blind (Weeks 1 - 24) | COMPLETED | Part 1/Part 2: Placebo/Vimseltinib | 35 | |
| Part 1: Double Blind (Weeks 1 - 24) | NOT COMPLETED | Part 1/Part 2: Vimseltinib/Vimseltinib | 8 | |
| Part 1: Double Blind (Weeks 1 - 24) | NOT COMPLETED | Part 1/Part 2: Placebo/Vimseltinib | 5 | |
| Part 2: Open Label (Weeks 25 - EoS) | STARTED | Part 1/Part 2: Vimseltinib/Vimseltinib | 74 | |
| Part 2: Open Label (Weeks 25 - EoS) | STARTED | Part 1/Part 2: Placebo/Vimseltinib | 35 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Total - Vimseltinib | 6 | 118 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 39 | 2 |
| other | Dry eye | Eye disorders | Total - Vimseltinib | 9 | 118 | 9 |
| other | Dry eye | Eye disorders | Placebo | 0 | 39 | 0 |
| other | Eyelid oedema | Eye disorders | Total - Vimseltinib | 11 | 118 | 19 |
| other | Eyelid oedema | Eye disorders | Placebo | 2 | 39 | 2 |
| other | Lacrimation increased | Eye disorders | Total - Vimseltinib | 10 | 118 | 12 |
| other | Lacrimation increased | Eye disorders | Placebo | 0 | 39 | 0 |
| other | Periorbital oedema | Eye disorders | Total - Vimseltinib | 53 | 118 | 87 |
| other | Periorbital oedema | Eye disorders | Placebo | 5 | 39 | 6 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total - Vimseltinib | 1 | 118 |
| Total, all-cause mortality | Placebo | 0 | 39 |
| Total, other adverse events | Total - Vimseltinib | 113 | 118 |
| Total, other adverse events | Placebo | 32 | 39 |
| Total, serious adverse events | Total - Vimseltinib | 17 | 118 |
| Total, serious adverse events | Placebo | 1 | 39 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Total - Vimseltinib vs Placebo: deaths from any cause | Trial comparisons |
| Total - Vimseltinib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05059262
GET https://conductscience.org/api/trials/v1/NCT05059262/events?page=2