Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SynOx Therapeutics Limited
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
