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Vimseltinib

Clinical trials are investigating Vimseltinib in patients with tenosynovial giant cell tumor, and in one earlier study also in people with advanced tumors. These studies aim to evaluate safety, response to treatment, and other measures such as how the body processes the study drug. Both Phase 1/2 and Phase 3 trials are included.

Table of contents

Trial overview

The trial data show two interventional studies of Vimseltinib, both marked as authorised.[1][2] One study is a Phase 3 trial in patients with tenosynovial giant cell tumor, and the other is a Phase 1/2 study in patients with advanced tumors and tenosynovial giant cell tumor.[1][2]

Conditions studied

The main condition studied is Tenosynovial Giant Cell Tumor, a rare tumor that affects tissue around joints and tendons.[1][2] In the Phase 1/2 study, the trial also included patients with advanced tumors, which means tumors that are more widespread or harder to treat.[2]

The Phase 3 study focused only on tenosynovial giant cell tumor.[1] The Phase 1/2 study had a broader population because it included both advanced tumors and tenosynovial giant cell tumor.[2]

Trial design and phases

The Phase 3 study was multicenter and randomized, which means it was run at more than one site and patients were assigned to groups by chance.[1] It also had two parts: Part 1 was double blinded, and Part 2 was open label.[1]

Double blinded means that neither the patient nor the study team knew who was receiving the active treatment or the placebo during that part of the trial.[1] Open label means that both the patient and the study team knew which treatment was being given.[1]

The Phase 1/2 study was also multicenter and open label.[2] This earlier study was designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and early signs of antitumor activity.[2]

Who can participate

From the trial data, the main group of participants is patients with tenosynovial giant cell tumor.[1][2] The Phase 1/2 study also allowed patients with advanced tumors, so this study had a broader entry group.[2]

The data do not list all detailed eligibility rules, so the exact participation criteria cannot be fully described here.[1][2] What is clear is that the studies were built around people with the target tumor type and, in one study, people with more advanced disease.[1][2]

What the trials measure

The Phase 3 study’s main outcome was objective response rate (ORR), including complete response and partial response, measured by RECIST v1.1 at Week 25.[1] RECIST v1.1 is a standard way to measure whether a tumor shrinks, stays stable, or grows on scans.[1]

The Phase 1/2 study looked at several safety outcomes, including dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, dose reduction or stopping the study drug because of toxicity, physical examination findings, ECOG performance status, lab changes, ECGs, left ventricular ejection fraction, and vital signs.[2] These measures help researchers understand how well the treatment is tolerated and how it affects the body.[2]

The same Phase 1/2 study also measured pharmacokinetics, which describes how the body absorbs, moves, and removes the study drug and its metabolite DP-7005 if detected.[2] The listed pharmacokinetic measures included Tmax, Cmax, Cmin, AUC, and t1/2.[2]

For efficacy in the TGCT expansion cohort, the Phase 1/2 study measured ORR at Week 25 and duration of response, which is the time from a complete or partial response until disease progression or death.[2]

Key trials in the data

NCT05059262 is a Phase 3, multicenter, randomized study in tenosynovial giant cell tumor with 123 planned participants.[1] It compared Vimseltinib with placebo and used a two-part design, with Part 1 double blinded and Part 2 open label.[1] The main endpoint was ORR at Week 25 by RECIST v1.1, reviewed by blinded independent radiological review.[1]

NCT03069469 is a Phase 1/2, multicenter, open-label study with 135 planned participants.[2] It studied patients with advanced tumors and tenosynovial giant cell tumor and focused on safety, pharmacokinetics, dose finding, and early antitumor activity.[2] In the TGCT expansion cohort, it also measured ORR and duration of response.[2]

Important terms explained

Interventional study means the researchers give a treatment and then watch what happens.[1][2] This is different from a study that only observes patients without assigning treatment.[1][2]

Enrolment is the number of people planned for a study.[1][2] In these trials, enrolment was 123 in the Phase 3 study and 135 in the Phase 1/2 study.[1][2]

Safety means the researchers are checking for unwanted medical problems during the study.[2] Efficacy means whether the treatment seems to work against the disease.[1][2]

Blinded independent radiological review means that scan results are checked by independent experts who do not know which treatment the patient received.[1] This helps make the result more objective.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05059262 Phase 3 Tenosynovial Giant Cell Tumor Authorised 123
NCT03069469 Phase 1/2 Advanced tumors and Tenosynovial Giant Cell Tumor Authorised 135

FAQ

  • What conditions are being studied in the Vimseltinib trials? The main condition studied is tenosynovial giant cell tumor. One earlier study also included patients with advanced tumors.
  • What phases are the Vimseltinib trials? The trial data include a Phase 1/2 study and a Phase 3 study. This means the research is looking at both early safety and later effectiveness.
  • What are the main goals of these trials? The trials aim to measure safety, how well the treatment works, and how the body handles the study drug. They also look at response rates and how long the response lasts.
  • Who can take part in these studies? The main target group is patients with tenosynovial giant cell tumor. One study also included patients with advanced tumors, so eligibility depends on the specific trial.
  • What results are the trials measuring? The studies measure objective response rate, which means how many patients have their tumor shrink or disappear. They also measure duration of response, safety findings, and drug levels in the body.

Sperimentazioni cliniche in corso su Vimseltinib

  • Studio sull’efficacia e sicurezza di Vimseltinib nei pazienti con Tumore a Cellule Giganti della Guaina Tendinea

    Arruolamento concluso

    1 1
    Malattie in studio:
    Farmaci in studio:
    Francia Germania Italia Paesi Bassi Norvegia Polonia +1

  • Studio sulla sicurezza ed efficacia di Vimseltinib nei pazienti con tumori avanzati e tumore a cellule giganti tenosinoviali

    Arruolamento concluso

    1 1
    Farmaci in studio:
    Francia Italia Paesi Bassi Polonia Spagna

Glossario

  • Tenosynovial Giant Cell Tumor: A rare tumor that affects the tissue around joints and tendons. It is the main condition studied in the Vimseltinib trials.
  • Advanced tumors: Tumors that are more widespread or harder to treat. One early study included patients with this type of cancer.
  • Phase 1/2: An early stage of research that checks safety first and also looks for signs that the treatment may work.
  • Phase 3: A later stage of research with more patients. It is used to compare treatment effects and confirm benefits.
  • Randomized: Patients are placed into study groups by chance. This helps make the comparison fair.
  • Placebo: A look-alike treatment with no active study drug. It is used to compare against the real treatment.
  • Double blinded: Neither the patient nor the study team knows who is receiving the active treatment or placebo during that part of the study.
  • Open-label: Both the patient and the study team know what treatment is being given.
  • Objective response rate (ORR): The percentage of patients whose tumors shrink or disappear during treatment.
  • Complete response (CR): No visible signs of the tumor on scans or examinations.
  • Partial response (PR): The tumor gets smaller, but does not disappear completely.
  • Duration of response (DOR): How long the tumor stays smaller or gone after a response is seen.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sullefficacia-e-sicurezza-di-vimseltinib-nei-pazienti-con-tumore-a-cellule-giganti-della-guaina-tendinea/
  2. https://studi-clinici.it/studio/studio-sulla-sicurezza-ed-efficacia-di-vimseltinib-nei-pazienti-con-tumori-avanzati-e-tumore-a-cellule-giganti-tenosinoviali/