NL-OMON51288撤回3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 3
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
- 年龄范围
- 12 至 64（—）
入选标准
- •1. Written informed consent.
- •2. 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).
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
- •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
- •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
- •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
- •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
- •specific treatment for the malignancy has not been administered within the
- •15. Planned surgery during the course of the study with the exception of dental
- •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
相似试验
进行中（未招募）
1 期
A Trial to Assess the Safety and Efficacy of Emactuzumab versus Placebo in Patients with Giant Cell Tumours.Tenosynovial Giant Cell TumourMedDRA version: 21.1Level: LLTClassification code 10025564Term: Malignant giant cell tumorSystem Organ Class: 100000004864EUCTR2021-001716-29-ESSynOx Therapeutics Ltd160
进行中（未招募）
不适用
Evaluation of Ceftaroline Fosamil versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.EUCTR2011-004013-16-BGAstraZeneca AB825
进行中（未招募）
不适用
Evaluation of Ceftaroline Fosamil versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.Complicated bacterial skin and soft tissue infectionsMedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-004013-16-GRAstraZeneca AB765
进行中（未招募）
1 期
A Trial to Assess the Safety and Efficacy of Emactuzumab versus Placebo in Patients with Giant Cell Tumours.EUCTR2021-001716-29-ATSynOx Therapeutics Ltd160
进行中（未招募）
不适用
Evaluation of Ceftaroline Fosamil versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.EUCTR2011-004013-16-ESAstraZeneca AB765