Study on Vimseltinib for Patients with Tenosynovial Giant Cell Tumor

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What is this study about?

This clinical trial is focused on studying a condition known as Tenosynovial Giant Cell Tumor (TGCT). TGCT is a type of tumor that affects the joints and can cause pain and stiffness. The study is testing a new treatment called Vimseltinib, which is taken as a capsule. The purpose of the study is to evaluate how effective and safe Vimseltinib is for patients with TGCT.

The study is divided into two parts. In the first part, participants will be randomly assigned to receive either Vimseltinib or a placebo, which looks like the medication but does not contain the active ingredient. This part of the study is double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication. In the second part, all participants will receive Vimseltinib, and this phase is open-label, meaning everyone will know they are receiving the medication.

Participants will take the medication orally and will be monitored over a period of time to assess the response of their tumor to the treatment. The study will also look at changes in joint movement, pain levels, and overall physical function. The goal is to see if Vimseltinib can reduce the size of the tumor and improve symptoms without causing significant side effects. The study will help determine if Vimseltinib is a viable treatment option for people with Tenosynovial Giant Cell Tumor.

1 Joining the study

Upon joining the study, the participant will be randomly assigned to receive either vimseltinib or a placebo. This is a double-blind study, meaning neither the participant nor the researchers will know which treatment is being administered during Part 1 of the study.

2 Medication administration

The participant will take the assigned medication orally in the form of a hard capsule. The specific dosage and frequency will be determined by the study protocol and communicated to the participant at the start of the trial.

3 Monitoring and assessments

Throughout the study, the participant will undergo regular assessments to monitor the response to the treatment. This includes imaging tests to evaluate tumor size and questionnaires to assess symptoms such as pain and stiffness.

The primary goal is to measure the objective response rate at Week 25, which includes any complete or partial response to the treatment.

4 Completion of Part 1

At the end of Part 1, which lasts until Week 25, the participant’s response to the treatment will be evaluated. This includes changes in joint function, pain levels, and overall health status.

5 Transition to Part 2

Part 2 of the study is open-label, meaning all participants will receive vimseltinib. The purpose of this phase is to continue monitoring the long-term effects and safety of the medication.

6 Ongoing evaluations

Participants will continue to have regular check-ups and assessments to track the duration of response and any side effects. This includes monitoring for any adverse events and changes in laboratory parameters.

7 Study conclusion

The study is expected to conclude by July 2026. At this point, all data will be analyzed to determine the overall efficacy and safety of vimseltinib for treating Tenosynovial Giant Cell Tumor.

Who Can Join the Study?

Participants must be male or female and 18 years of age or older.
Participants who can have children must:
- Have a negative pregnancy test at the start of the study (for females).
- Agree to use birth control as described in the study plan.
Participants must understand and agree to follow the study rules and sign a consent form before starting any study-related activities.
Participants must be willing and able to complete questionnaires on an electronic device.
Participants must have a confirmed diagnosis of Tenosynovial Giant Cell Tumor (TGCT), which may require a tumor biopsy if previous test results are not available. The tumor should be in a single joint where range of motion can be checked.
The disease should be such that surgery could lead to worse movement problems or serious health issues, as determined by a doctor or a group of specialists.
Participants must have symptoms like moderate pain or stiffness, rated as a score of 4 or more out of 10, recorded during the screening period.
Participants must complete 14 days of questionnaires during the screening period and meet the minimum requirements set in the study plan.
If participants are using pain medication, the dose must not change for at least 2 weeks before starting the study drug.
Participants must have a measurable tumor of at least 2 cm in size, as seen on an MRI scan.
Participants must have adequate organ function and bone marrow reserve, shown by specific lab tests done within 21 days before starting the study drug. This includes:
- Bone marrow function: certain levels of blood cells and platelets.
- Liver function: certain levels of bilirubin and liver enzymes.
- Kidney function: a creatinine clearance of 50 mL/min or more.
- Normal levels of electrolytes like potassium, magnesium, and calcium.
Participants must be able to take oral medication.

Who Cannot Join the Study?

Patients who have a different type of tumor than Tenosynovial Giant Cell Tumor cannot participate. This is a specific type of tumor that affects the tissue around joints and tendons.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or who have conditions that might interfere with the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
Patients who have participated in another clinical trial recently may not be eligible, as this could affect the study results.
Patients with certain medical conditions that could interfere with the study or pose a risk to their health cannot participate.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study procedures, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Uslbfoazhcmvwlgqmxzex Ebead Anh	Essen	Germany
Itxmyh Iulaaqdr Fmphuhueahjln Obdwrtchjue	Rome	Italy
Lufgu Uxxjdbrtvhtl Mwfwvpx Ckjjxzn (cfsjz	Leiden	The Netherlands
Npvltopu Ikvhynpx Onqrutbba Iur Msrtd Shfxyakxqcjuiasznwqsctxcykfz Insbkqqq Bdqsvtfh	Cracow	Poland
Cioavv Lzck Byuuhv	Lyon	France
Htsxphch Vjeg dukxewcn	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	10.01.2023
Germany	Not recruiting	10.01.2023
Italy	Not recruiting	10.01.2023
Norway	Not recruiting	10.01.2023
Poland	Not recruiting	10.01.2023
Spain	Not recruiting	10.01.2023
The Netherlands	Not recruiting	10.01.2023

Trial locations

Investigated drugs:

Vimseltinib

Vimseltinib is a medication being studied for its ability to reduce the size of tumors in patients with Tenosynovial Giant Cell Tumor. This trial aims to assess how well the medication works in shrinking tumors by using specific criteria to measure changes in tumor size.

Investigated diseases:

Myasthenia gravis

Tenosynovial Giant Cell Tumor – This is a type of non-cancerous tumor that affects the synovium, which is the lining of joints and tendons. It often occurs in the knee, hip, ankle, or fingers, leading to swelling and pain in the affected area. The tumor can grow slowly and may cause joint stiffness and reduced range of motion over time. Although it is not cancerous, it can cause significant discomfort and impair joint function. The condition may recur after treatment, necessitating ongoing monitoring. It is more common in adults and can vary in size and severity.

Trial ID:

2024-513624-42-00

Protocol code:

DCC-3014-03-001

NCT ID:

NCT05059262

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Vimseltinib for Patients with Tenosynovial Giant Cell Tumor

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