Study of emactuzumab compared to placebo in patients with tenosynovial giant cell tumor

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What is this study about?

This study focuses on Tenosynovial Giant Cell Tumour (TGCT), which is a rare type of growth that affects the tissue lining around joints and tendons. The study will test a medication called emactuzumab, which will be given through intravenous infusion, comparing it with placebo to determine if it can effectively treat this condition.

The purpose of this research is to evaluate how well emactuzumab works in treating TGCT by measuring the rate at which tumors respond to treatment within 6 months of starting therapy. The medication will be given as a solution that is administered directly into a vein. Some participants will receive emactuzumab, while others will receive placebo.

During the study, participants will first take part in a 6-month phase where they will receive either emactuzumab or placebo without knowing which treatment they are getting. The study will track various aspects of participants’ health, including their pain levels, joint stiffness, and physical function. Doctors will use magnetic resonance imaging (MRI) to monitor changes in the tumors. The total treatment period may last up to 10 months, and participants will be monitored for any effects of the treatment.

1 Initial evaluation and randomization

You will be randomly assigned to receive either emactuzumab or placebo through intravenous infusion

Your tumor must be measurable with a longest diameter of at least 20 mm

Initial assessments will include blood tests to confirm adequate organ and bone marrow function

2 Treatment phase – first 6 months

You will receive either emactuzumab or placebo through IV infusion

Regular assessments will track changes in pain and stiffness using a numerical rating scale

Your joint mobility will be measured regularly

Imaging scans will be performed to measure tumor response

You will complete quality of life questionnaires during visits

3 6-month evaluation

Your tumor response will be evaluated using imaging scans

Your physical function and symptoms will be assessed

The effectiveness of the treatment will be measured

4 Open-label phase option

If your disease progresses after the 6-month period, you may be eligible to receive emactuzumab

At least 3 months must pass between completing the initial treatment and starting open-label treatment

Any side effects from the previous treatment must have improved to mild level or less

This phase is only available for adult patients who completed the initial 6-month phase

5 Safety monitoring

Regular monitoring of side effects throughout the study

Blood tests will be performed to check organ function

Your ability to work and general health status will be tracked

Who Can Join the Study?

Must provide written informed consent to participate in the study
Must have confirmed TGCT (Tenosynovial Giant Cell Tumour) through biopsy, where surgery is not recommended due to:
– Risk of joint function limitations
– High chance of tumor returning after surgery
– Surgery unlikely to improve patient’s condition
– Other health issues making surgery risky
Must have a measurable tumor of at least 20 millimeters in size
Must be at least 12 years old and weigh at least 30 kilograms
Must have adequate blood test results showing:
– Hemoglobin above 10.0 g/dL
– Neutrophils (white blood cells) above 1.5 × 109/L
– Platelets above 100 × 109/L
Must have an average pain score of at least 4 on a pain scale during the week before starting the study
Must have an average stiffness score of at least 4 on a stiffness scale during the week before starting the study
Women who can become pregnant must:
– Have negative pregnancy tests
– Use effective birth control during treatment and for 7 months after
– Acceptable birth control methods include hormonal contraception, IUD, tubal ligation, or partner’s vasectomy
Men with partners who can become pregnant must use barrier contraception during treatment and for 5 months after, unless surgically sterile

Who Cannot Join the Study?

Age below 18 years or above 75 years
Pregnant or breastfeeding women
History of other cancers within the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
Presence of active infections requiring systemic treatment
Serious heart conditions, including:
- Uncontrolled high blood pressure
- Heart attack within the past 6 months
- Unstable heart rhythm problems
Severe liver disease
Severe kidney disease requiring dialysis
Known allergies to study medication or its components
Participation in other clinical trials within the past 30 days
Mental conditions that could interfere with following study procedures
Use of medications that could interact with the study drug
History of organ transplantation
Active autoimmune diseases requiring immunosuppression
Inability to swallow oral medications
Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Medical University Of Vienna	Vienna	Austria

Other Sites

Site Name	City	Country
Istituto Ortopedico Rizzoli	Bologna	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universita’ Di Pisa	Pisa	Italy
Azienda USL Toscana Centro	Prato	Italy
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Ccsnsxmiu Uqvhaadxelovkm Sunavjmcu	Woluwe-Saint-Lambert	Belgium
Cpiquk Lhfh Bkgujz	Lyon	France
Imizvs Iajtbsev Fnabxdwcebhqb Ophwbemndtl	Rome	Italy
Lkqev Utzlaetjkuht Mauwrnd Crtfcfu (dxtsz	Leiden	The Netherlands
Oltjzs Syrgqds Wbfkercgppraeipyaviy Sjr z omhi	Komorowice	Poland
Mtafiag Ufgnxklzbt Oz Ghvq	Graz	Austria
Nmfiykud Ilrmtyrj Ozjmedsmn Igd Mscph Sqignduygjhwdvighmeyqrnrupnc Irkajffn Brfcnzls	Cracow	Poland
Hbupoprv Dd Ln Satmv Clfu I Sxdl Pgg	Barcelona	Spain
Cbdxxk Oekdy Lnwlpfp	Lille	France
Inxkrvfc Ccbhv	Paris	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.09.2024
Belgium	Not recruiting	01.09.2024
France	Not recruiting	01.09.2024
Italy	Not recruiting	01.09.2024
Poland	Not recruiting	01.09.2024
Spain	Not recruiting	01.09.2024
Sweden	Not recruiting	01.09.2024
The Netherlands	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Emactuzumab

Emactuzumab is a medication being studied for the treatment of Tenosynovial Giant Cell Tumor. It is a targeted therapy that works by blocking specific proteins that contribute to tumor growth. This medication is being tested to see if it can help reduce tumor size and improve symptoms in patients with this rare joint condition.

Placebo is an inactive substance that contains no medication. It is used as a comparison to determine if emactuzumab is effective in treating the condition. Some patients in the study will receive the placebo instead of the active medication to help researchers understand how well emactuzumab works.

Investigated diseases:

Giant cell tumour of tendon sheath

Tenosynovial Giant Cell Tumour – A rare, non-cancerous growth that affects the joints, particularly in the knees, hips, ankles, or other large joints. The condition develops in the synovial membrane, which is the protective lining of joints and tendons. The tumor causes the synovial tissue to thicken and overgrow, leading to swelling, stiffness, reduced movement, and pain in the affected joint. This condition can occur in two forms: a localized form that affects a specific area of a joint, and a diffuse form that impacts larger areas of the joint lining. The tumor can gradually limit joint function and mobility over time.

Trial ID:

2023-510422-32-00

Protocol code:

SNX-301-020

NCT ID:

NCT05417789

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of emactuzumab compared to placebo in patients with tenosynovial giant cell tumor

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?