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Study on the Safety and Effectiveness of ABSK021 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). This is a type of tumor that affects the joints and can cause pain and stiffness. The study is testing a new treatment called ABSK021, which is taken as a capsule. The purpose of the study is to determine if ABSK021 is safe and effective in treating TGCT.

Participants in the study will be randomly assigned to receive either the ABSK021 treatment or a placebo. The study will last for up to 48 weeks, during which participants will take the medication and attend regular check-ups. These check-ups will help researchers monitor the effects of the treatment on the tumor and any changes in symptoms like joint movement, stiffness, and pain.

The study aims to see how well the treatment works by measuring the size of the tumor and assessing improvements in joint function and quality of life. Participants will be closely monitored to ensure their safety throughout the study. The results will help determine if ABSK021 can be a beneficial treatment option for people with Tenosynovial Giant Cell Tumor.

1 randomization

Upon joining the study, participants are randomly assigned to receive either the study drug ABSK021 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

2 treatment administration

Participants take the assigned treatment orally in the form of a capsule. The specific dosage and frequency are determined by the study protocol and are followed throughout the trial period.

3 treatment duration

The treatment is administered over a period of 25 weeks. During this time, participants are monitored for any changes in their condition and any side effects.

4 evaluation of response

The primary goal is to assess the Objective Response Rate (ORR) within 25 weeks, based on specific criteria. This involves measuring the size of the tumor and evaluating any changes.

5 secondary assessments

Additional assessments include changes in joint movement, stiffness, pain levels, and overall physical functioning. These are measured using various scales and questionnaires.

6 end of treatment evaluation

At the end of the 25-week period, a comprehensive evaluation is conducted to determine the overall effectiveness of the treatment and any lasting effects.

Who Can Join the Study?

  • Patients should understand the study procedures and sign the informed consent form before the screening process begins.
  • Patients must be 18 years or older.
  • Patients must have a histologically confirmed Tenosynovial Giant Cell Tumor (TGCT) that cannot be treated with surgery before the study starts. Histologically confirmed means that the diagnosis was made by examining tissue under a microscope.
  • Patients must have a measurable disease as defined by RECIST 1.1, with at least one tumor or lesion that is 2 centimeters or larger before the study starts. Measurable disease means that the tumor can be measured in size.
  • Patients who need pain medication must have a stable prescription for their pain medication during the 2 weeks before the study starts.
  • Patients should complete stiffness and pain scales during the screening period, and their symptoms due to active TGCT should meet the minimum requirements as outlined in the study protocol.
  • Patients must have adequate organ function and bone marrow function. This means their organs and bone marrow, which is the soft tissue inside bones, are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients who have a different condition than Tenosynovial Giant Cell Tumor cannot participate. This is a specific type of tumor that affects the lining of joints and tendons.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is defined by the study organizers.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Academisch Ziekenhuis Leiden Leiden The Netherlands
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Azienda USL Toscana Centro Prato Italy
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Istituto Ortopedico Rizzoli Bologna Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hebnjohc Vwza dexblwlq Barcelona Spain
Cgwput Oqzuo Lsozrdv Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
15.08.2023
Italy Italy
Not recruiting
15.08.2023
Poland Poland
Not recruiting
15.08.2023
Spain Spain
Not recruiting
15.08.2023
The Netherlands The Netherlands
Not recruiting
15.08.2023

Trial locations

Investigated drugs:

ABSK021 is a medication being studied for its effectiveness and safety in treating patients with Tenosynovial Giant Cell Tumor (TGCT). This trial aims to determine how well ABSK021 works in reducing the size of the tumor and improving symptoms in patients over a period of 25 weeks. The study compares the results of patients taking ABSK021 to those who do not receive the active medication.

Investigated diseases:

Tenosynovial Giant Cell Tumor – This is a rare, non-cancerous tumor that typically affects the synovium, bursae, and tendon sheaths. It often occurs in the joints, most commonly in the knee or hip, and can cause swelling, pain, and reduced joint movement. The tumor grows slowly and can vary in size, sometimes becoming large enough to cause significant discomfort or joint dysfunction. It is characterized by the overgrowth of the synovial tissue, which can lead to joint damage if left untreated. The condition is more prevalent in young to middle-aged adults and can affect both men and women. Although benign, it can recur after surgical removal, necessitating careful monitoring.

Trial ID:
2023-503245-58-00
Protocol code:
ABSK021-301
Trial Phase:
Therapeutic confirmatory (Phase III)

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