Prospective, multi-center, randomized, double-blind,two-arm, parallel group, active control, comparativeclinical study to evaluate efficacy and safety of R-TPR-045 / XgevaÂ® for prevention of skeletal related events inpatients with bone metastases from solid tumours

Reliance Life Sciences Pvt Ltd15 个研究点分布在 1 个国家目标入组 136 人开始时间: 2018年9月28日最近更新: 2019年12月24日

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方: Reliance Life Sciences Pvt Ltd
入组人数: 136
试验地点: 15
主要终点: solid tumours receiving R-TPR-045 / XgevaÂ®.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a prospective, multi-center, randomized, double-blind, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-045 / XgevaÂ® for prevention of skeletal related events in patients with bone metastases from solid tumours.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator 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

•Males and females patients of â‰¥18 -65 years of age.
•Patients with bone metastases from solid tumours and radiographic evidence of at least one bone metastasis
•Patients with ECOG PS â‰¤ 2 (after excluding skeletal related morbidity)
•Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
•The screening laboratory tests must meet the following criteria: â€¢ Haemoglobin â‰¥9.0 g/dL.
•â€¢ WBC â‰¥3.5 x 109/L â€¢ Neutrophils â‰¥1.5 x 109/L â€¢ Platelets â‰¥100 x 109/L â€¢ Serum transaminase â‰¤2 times the upper limit of normal â€¢ Alkaline phosphatase levels â‰¤2 times the upper limit of normal â€¢ Serum creatinine â‰¤150 Î¼mol/L (â‰¤1.7mg/dL)
•Subjects must have the ability to understand and comply with instructions and be able to complete study-related forms and questionnaires.
•Men and women of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication
•Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.

排除标准

•Patients with multiple myeloma
•Patients who had disorders associated with abnormal bone metabolism including uncontrolled hyper- or hypothyroidism or Pagetâ€™s disease; untreated or symptomatic brain metastases
•Patients currently receiving therapy with chronic systemic corticosteroid administration; or received calcitonin, parathyroid hormone related peptides, mithramycin, strontium ranelate, or gallium nitrate within 8 weeks of random assignment
•Patients with life expectancy <6 months
•Patient with severe renal impairment (creatine clearance <30 mL/min) or receiving dialysis.
•Patients with severe, untreated hypocalcaemia
•Patient with rare hereditary problems of fructose intolerance
•Prior use of Denosumab or ongoing treatment with bisphosphonates.
•Hypersensitivity to the active substance or to any of the excipients
•Patient with invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery in last 6months before screening), poor oral hygiene or other pre-existing dental disease
•Current use or known history of systemic (injectable or oral) corticosteroid medication use in last 6 months before screening Visit.
•Patients with planned radiation therapy or surgery to bone
•Patients with current or previous osteonecrosis or osteomyelitis of the jaw, any planned invasive dental procedure during the study
•Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis etc.).
•Current smoker or smoking history within 12 months prior to the Screening Visit.
•Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen; Unstable angina; New York Heart Association (NYHA) greater than/equal to grade 2 congestive heart failure
•Myocardial infarction within 6 months of study enrollment; History of stroke within 6 months of study enrollment; Unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible); Clinically significant peripheral vascular disease; Uncontrolled diabetes; Serious active or uncontrolled infection
•History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
•Inability to comply with study and/or follow-up procedures.
•Subjects who are HIV, HBsAg, HCV test positive.
•Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the subject incapable of participating in the study
•History of serious infection, which caused hospitalization within 6 months prior to randomization or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, invasive fungal infection such as histoplasmosis, or a history of recurrent herpes zoster or other chronic or recurrent infection) or a past diagnosis without sufficient documentation of complete resolution following treatment.
•Pre-existing central nervous system demyelinating disorders.
•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.
•Participation in any clinical study of an investigational product within the previous 3 months.