Informations générales (source: ClinicalTrials.gov)
A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab Vs. Placebo in Subjects with Tenosynovial Giant Cell Tumour (TANGENT)
Interventional
Phase 3
SynOx Therapeutics Limited (Voir sur ClinicalTrials)
avril 2024
septembre 2027
05 avril 2025
This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which
aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the
treatment of patients with localized or diffuse TGCT where surgical removal of the tumor
is not viewed as an option.
The study consists of two parts. In Part 1, eligible subjects will be assigned in a 2:1
ratio to receive either emactuzumab or matching placebo in a double-blind fashion, that
will be administered in total 5 times as an intravenous (i.v.) infusion once every 2
weeks. This will be followed by an observation period of 3 months leading to a total
duration of 24 weeks in Part 1. A number of assessments will be carried out during the
course of the study, including physical examinations, blood tests, imaging studies,
electrocardiograms, and questionnaires. Part 2 is a long-term double-blind follow-up
phase of the subjects on emactuzumab or placebo. Subjects assigned to placebo in Part 1
have the option, subject to eligibility, to crossover to receive open-label emactuzumab
in Part 2. Subjects assigned to active drug in Part 1 have the option to receive
open-label retreatment under certain circumstances.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:06 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - Alpes-Maritimes - France | Dr Agnès Ducoulombier | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes - 69373 - Lyon - Rhône - France | Dr Jean-Yves Blay | Contact (sur clinicalTrials) | |||
| Institut Bergonie - PPDS - 33000 - Bordeaux - Gironde - France | Dr Antoine Italiano | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de Ouest - Saint Herblain - 44115 - Saint-Herblain - Loire-Atlantique - France | Dr Emmanuelle Bompas | Contact (sur clinicalTrials) | |||
| Oncopole Claudius Regaud Oncologie Médicale - 31059 - Toulouse - France | Dr Valentin Thibaud | Contact (sur clinicalTrials) | |||
| UNICANCER - Centre Oscar Lambret - 59000 - Lille - France | Dr Thomas Ryckewaert | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age >12 years
- Biopsy-confirmed (standard of care diagnosis history) local or diffuse TGCT where
surgical resection would be associated with predicted worsening functional
limitations through surgical joint damage, and/or subject has an anticipated high
risk of early recurrence as determined by a multidisciplinary tumour board or
equivalent, or any other morbidity associated with the surgery, and/or surgical
treatment is not expected to improve the clinical outcomes of the subject.
- Measurable disease: longest diameter ≥20 mm.
- Adequate organ and bone marrow function
- If a woman of childbearing potential (WOCBP), must have a negative pregnancy test
prior to starting treatment and agree to use a highly effective method of
contraception
- Participants must have given written consent
- Age >12 years
- Biopsy-confirmed (standard of care diagnosis history) local or diffuse TGCT where
surgical resection would be associated with predicted worsening functional
limitations through surgical joint damage, and/or subject has an anticipated high
risk of early recurrence as determined by a multidisciplinary tumour board or
equivalent, or any other morbidity associated with the surgery, and/or surgical
treatment is not expected to improve the clinical outcomes of the subject.
- Measurable disease: longest diameter ≥20 mm.
- Adequate organ and bone marrow function
- If a woman of childbearing potential (WOCBP), must have a negative pregnancy test
prior to starting treatment and agree to use a highly effective method of
contraception
- Participants must have given written consent
- If a female, the subject is pregnant or breast feeding.
- Medical conditions, including auto-immune, requiring systemic immunosuppression. Any
systemic treatment for these conditions (eg, glucocorticoids) is not allowed within
4 weeks of Screening and during the study.
- Known metastatic TGCT or other active cancer that requires concurrent or planned
treatment
- Received systemic therapy for TGCT (investigational or approved) targeting CSF-1 or
CSF-1R or any multi-tyrosine kinase inhibitor (eg nilotinib and imatinib) within 3
months prior to screening
- Any surgery, chemotherapy or radiotherapy within 3 months of screening
- Unresolved clinically significant toxicity from a previous treatment or any history
of serious liver toxicity.
- Current or chronic history of liver disease.
- Inadequate renal and liver function
- Systemic antiretroviral therapy within 3 months of baseline
- Within 6 months of baseline has experienced: clinically significant myocardial
infarction, severe/unstable angina pectoris, congestive heart failure New York Heart
Association (NYHA) Class III or IV, or pulmonary disease (NYHA Criteria 1994)
including severe thromboembolic event; incompletely healed clinically significant
wounds, including bone fractures; pathological fracture or significant
hypercalcaemia.