Comparative pharmacokinetic, pharmacodynamic, safety, efficacy and immunogenicity study of VBDNSM01 (Virchow Denosumab) versus Xgeva (Amgen Denosumab) in patients with bone metastasis from solid tumours
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 23
- 主要终点
- Proportion of patients having skeletal-related events
研究概览
简要总结
Randomized, controlled, open-label, multicentre, comparative clinical trial. The primary objective of the study is to evaluate the efficacy of Virchow’s Denosumab (test product) with that of Xgeva (reference product) in patients with bone metastasis from solid tumours. Patients will be randomized in 1:1 ratio to one of the following groups: Group 1: VBDNSM01 (Virchow Biotech - Denosumab) Each single vial contains 120 mg of Denosumab in 1.7 mL of solution (70 mg/mL). Frequency: every 4 weeks; Mode of Administration: Subcutaneous; Duration of treatment: 24 weeks (a total of six doses); Group 2: Xgeva (Amgen - Denosumab) Each single vial contains 120 mg of Denosumab in 1.7 mL of solution (70 mg/mL). Frequency: every 4 weeks; Mode of Administration: Subcutaneous; Duration of treatment: 24 weeks (a total of six doses). Eligible patients will be randomised to receive either Virchow Biotech Denosumab or Xgeva in 1:1 ratio. Patients will receive 120 mg of denosumab every 4 weeks for 24 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen as per the randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female with ≥ 18 to ≤ 75 years.
- •2.Histological or Cytological confirmation of Breast adenocarcinoma or Prostate cancer or Non-small cell lung cancer.
- •3.Radiographic evidence of atleast 1 bone metastasis (Confirmed by X-ray, computed tomography, magnetic resonance imaging or bone scan).
- •4.Eastern Cooperative Oncology Group performance status ≤
- •5.Willing to provide written informed consent and comply with protocol requirements.
- •6.Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •7.Patients of child-bearing potential must agree to use acceptable methods of contraception (as per investigator discretion) during the study.
- •Female patients of child bearing potential must agree to use contraceptive methods for atleast 5 months after the last dose of the drug.
排除标准
- •1.History of hypersensitivity to denosumab or prior use of denosumab.
- •2.Any of the following oral/dental conditions: Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
- •Active dental or jaw condition which requires oral surgery.
- •Planned invasive dental procedure.
- •Non-healed dental or oral surgery.
- •3.Administration of intravenous (IV) bisphosphonates, fluoride, or strontium for osteoporosis within the last 1 year or oral bisphosphonates treatment for osteoporosis in last 3 months.
- •4.Currently enrolled in or has not yet completed at least 30 days (or 5 half-lives, whichever is longer) since ending earlier investigational device or drug trial(s), or patient is receiving another investigational agent(s).
- •5.Planned bone surgery or radiation to the bone.
- •6.Life expectancy less than 6 months.
- •7.Serum calcium levels ≤8 mg/dl.
- •8.Estimated creatinine clearance ≤30 ml/min.
- •9.Females with a positive pregnancy test at screening or lactating females.
- •10.Tested positive for HIV, HCV or HBsAg or known to be tested positive.
- •11.Un controlled hypertension (Blood pressure ≥ 140 by 90 mm of Hg).
- •Patient on stable antihypertensive medication for more than 3 months with controlled hypertension will be eligible.
- •12.Any other significant medical condition which in the opinion of the investigator increases the safety risk if patient participate in the trial.
- •13.Clinically relevant ECG abnormality that affects the successful completion of patient’s treatment in the trial as per investigator.
- •14.Recent history (within the past 1 year) of myocardial infarction or cerebral stroke or patients with NYHA III or IV heart failure.
- •15.History of drug or alcohol abuse within the 12 months prior to dosing.
- •16.Any of the following abnormal investigational values: a.General: Any laboratory abnormality which, in the opinion of the Investigator, would prevent the patient from safely completing the study or interfere with the interpretation of the study results.
- •b.Liver transaminases: i.AST or SGOT ≥2.0 x upper limits of normal ULN; ii.ALT or SGPT ≥2.0 x ULN; iii.
- •Alkaline phosphatase and bilirubin ≥1.5 x ULN.
结局指标
主要结局
Proportion of patients having skeletal-related events
时间窗: 24 weeks
次要结局
- 1. Proportion of patients having skeletal-related events at week 12;(week 12)
- 2. Time to first skeletal-related events(0-24 weeks)
- 4. Mean decrease in urinary N-telopeptide adjusted for creatinine (uNTx/Cr) from baseline to week 4, 12, 20 and 24(week 4, 12, 20 and 24)
研究者
Dr Hemanth Nandigala
Virchow Biotech Private Limited