CTRI/2023/09/057660招募中3 期
A Phase IIIb, Prospective, Multicenter, Parallel, Assessor Blinded Extension Study to Evaluate the long-term Efficacy, Immunogenicity, Safety of Subcutaneous Injection of Denosumab (Hetero) in patients with bone metastases from solid tumours
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Median time to first on-study Skeletal Related Events (SRE) including hypercalcemia of malignancy associated with bone metastases/lesions during 12 months.
研究概览
简要总结
· This study is an extension study of HCR/III/DENOSOL/12/2019 to evaluate the long-term efficacy, immunogenicity and safety of subcutaneous Hetero-denosumab and Reference medicinal product (Denosumab, Amgen) in patients with bone metastases from solid tumours, who have completed 24 weeks (06 months) treatment on the HCR/III/DENOSOL/12/2019 study.
· This study will be an assessor blinded, active controlled, comparative, parallel group study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who have completed the 24 weeks of study HCR/III/DENOSOL/12/
- •2.Patients with ECOG score
- •2 3.Patients willing to provide written Informed Consent for extension study, and able to adhere to study schedules and requirements. 4.Patients with screening laboratory tests within the following criteria: a.Haemoglobin ≥9.0 g/dL b.WBC ≥3.5 X 109/L c.Absolute Neutrophil Count ≥1.5 X 109/L d.Platelets ≥100 X 109/L e.Serum transaminase levels ≤2.5xULN (≤5xULN, in case of liver metastases) f.Alkaline phosphatase levels ≤5xULN g.Serum creatinine levels ≤150 μmol/L (≤1.7mg/dL) h.Serum calcium (corrected) levels ≥ 8 to 11.5 mg/dL (2 to 2.9 mmol/L) 5.Women of childbearing potential should neither become pregnant nor lactate and must be using barrier methods of birth control measures during the study period and for 6 months after receiving the last injection of study medication.
排除标准
- •1.Patients with untreated or symptomatic brain metastases.
- •2.Patient with severe renal impairment (creatinine clearance <30 mL/min) or receiving dialysis.
- •3.Patients with severe hypocalcaemia (corrected serum calcium of < 8.0 mg/dL or <2 mmol/L).
- •4.Patients with current or previous osteonecrosis or osteomyelitis of the jaw or non-healed dental/oral surgery or any planned invasive dental procedure during the study.
- •5.Current signs or symptoms of significant, progressive or uncontrolled renal, hepatobiliary, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, vascular, neurologic or cerebral, psychiatric disease that renders the subject incapable of participating in the study.
- •6.Patients with disorders associated with abnormal bone metabolism including uncontrolled hyperthyroidism or hypothyroidism, hyperparathyroidism or hypoparathyroidism, Paget’s disease, osteomalacia, osteogenesis imperfecta, Cushing’s disease or hyperprolactinemia.
- •7.Patients requiring radiotherapy or surgery to bone metastases; or those currently receiving oral bisphosphonates; or have previously received IV bisphosphonate therapy for treatment of bone metastases.
- •8.Severe and/or uncontrolled conditions which could compromise participation in the study: uncontrolled blood pressure (>140/90 mm of Hg); unstable angina; congestive heart failure (NYHA grade 3 or more, history of myocardial infarction or stroke within previous 6 months of randomization; symptomatic arrhythmia requiring medication.
- •9.History or presence of any medical or psychiatric condition or disease, or clinically significant laboratory abnormality, physical examination findings or any other condition that, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation and may prevent the subject from completing the study.
- •10.History of cirrhosis of the liver or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones) 11.Patient who has discontinued/withdrawn from the study HCR/III/DENOSOL/12/
- •12.Patient who has tested positive for anti-denosumab antibodies in previous study HCR/III/DENOSOL/12/
- •13.Patient who has not benefited from denosumab therapy in study HCR/III/DENOSOL/12/2019 as per Investigator’s discretion.
结局指标
主要结局
Median time to first on-study Skeletal Related Events (SRE) including hypercalcemia of malignancy associated with bone metastases/lesions during 12 months.
时间窗: 12 Months
Proportion of patients with first on-study Skeletal Related Events (SRE) including hypercalcemia of malignancy associated with bone metastases/lesions for 12 months.
时间窗: 12 Months
次要结局
- Median time to first & subsequent on-study SREs associated with bone metastases/lesions.(12 months)
- Proportion of patients with first & subsequent on-study SREs associated with bone metastases/lesions.(12 months)
- Mean number of on-study SREs associated with bone metastases/lesions.(12 months)
- Comparative incidence & titers of anti-denosumab antibodies.
- Comparative safety & tolerability for treatment emergent adverse events by monitoring of significant clinical signs & symptoms & laboratory abnormalities during treatment.(12 months)
研究者
研究点 (10)
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