EUCTR2021-001716-29-AT进行中（未招募）1 期
A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy ofEmactuzumab vs. Placebo in Subjects with Tenosynovial Giant Cell Tumour. - TANGENT
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Written informed consent.
- •2. Biopsy-confirmed (standard of care diagnosis history) local or diffuse TGCT where surgical resection would be associated with predicted worsening functional limitations due to surgical damage to the joint and adjacent soft tissues, and/or subject presents with
- •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.
- •*The multidisciplinary tumour board or equivalent must comprise at least 2 individuals:
- •the Investigator plus at least one other qualified physician (orthopaedic surgeon or
- •medical oncologist) not involved in this study.
- •3. Measurable disease: longest diameter =20 mm.
- •4. Age >12 years.
- •5. Adequate organ and bone marrow function: haemoglobin (Hb) >10.0 g/dL,
- •neutrophils >1.5 × 109/L and platelets >100 × 109/L.
- •6. Minimum mean score of 4 on NRS for Worst Pain during 7 days prior to randomization,
- •based upon a minimum of 4 days of completed diary data.
- •7. Minimum mean score of 4 on NRS for Worst Stiffness during 7 days prior to
- •randomization, based upon a minimum of 4 days of completed diary data.
- •8. Women of childbearing potential (WOCBP) must have a negative urine and serum pregnancy test prior to starting treatment. WOCBP must agree to use a highly effective method of contraception throughout the treatment period and for 7 months after
- •discontinuation of treatment. Acceptable methods of contraception according to protocol description.
- •9. For Open-Label Phase ONLY:
- •Subjects must either:
- •-Have responded based on RECIST v1.1 (CR or PR) to initial treatment with emactuzumab during the Double-Blind Phase and then progressed (objective progressive disease on imaging) within 9-18 months of initial treatment on D 1 (Visit 1) with a minimum 6-month washout period between treatments; or
- •-Have received placebo and completed the 6-month visit on D 181/Visit 10
- •(3 months treatment and 3 months observation) of the Double-Blind Phase and
- •have not completed more than 18 months of the study since initial treatment on D1 (Visit1).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. Pregnant or breast feeding.
- •2. 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. All Lupus Erythematosus are excluded
- •irrespective of treatment.
- •3. Metastatic TGCT.
- •4. TGCT currently affecting multiple joints.
- •5. Pexidartinib therapy within 3 months of Screening.
- •6. otinib, imatinib; other chemotherapy, radiotherapy, or investigational therapy within 4
- •weeks of Screening.
- •7. Unresolved clinically significant toxicity from a previous treatment or any history of
- •serious liver toxicity.
- •8. Current or chronic history of liver disease. This includes, but is not limited to, hepatitis
- •virus infections, drug- or alcohol-related liver disease, nonalcoholic steatohepatitis,
- •autoimmune hepatitis, haemochromatosis, Wilson’s disease, a-1 antitrypsin deficiency,
- •primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease
- •which in the opinion of the Investigator is considered clinically significant.
- •9. Renal function: creatinine clearance <60 mL/min (Cockcroft-Gault formula).
- •10. Liver function: ALT >3.0 × ULN; OR total bilirubin >1.5 × ULN.
- •11. 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).
- •12. Clinically significant active infection requiring systemic antibiotic treatment.
- •Rescreening may occur any time after 7 days post completion of treatment.
- •13. Systemic antiretroviral therapy within 3 months of baseline.
- •14. Other active cancer that requires concurrent treatment or history of malignancy other than
- •TGCT, unless there is the expectation that the malignancy has been cured, and tumor
- •specific treatment for the malignancy has not been administered within the previous
- •15. Planned surgery during the course of the study with the exception of dental treatment.
- •16. Inability to comply with the study procedures.
- •17. For the Double-Blind Phase ONLY:
- •Previous exposure to emactuzumab and/or neutralizing antibodies.
研究者
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