CTRI/2021/06/034402已完成4 期
A prospective, multi-center, single arm, open label, Phase IV clinical study to evaluate safety and efficacy of DenosuRel™ containing Denosumab manufactured by Reliance Life Sciences Pvt. Ltd. India for prevention of skeletal related events in patients with bone metastases from solid tumours - K099_DenosuRel™ Phase IV study
Reliance Life Sciences Pvt Ltd RLS0 个研究点目标入组 220 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
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
入选标准
- •1.Male and female patients of =18 - 70 years of age (both inclusive).
- •2.Patients with bone metastases from solid tumours and radiographic evidence of at least one bone metastasis.
- •3.Patients with ECOG PS = 2 (after excluding skeletal related morbidity).
- •4.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.
- •5.The screening laboratory tests must meet the following criteria:
- •- Haemoglobin >8.0 g/dL.
- •- WBC =3.5 x 109/L
- •- Neutrophils =1.5 x 109/L
- •- Platelets =100 x 109/L
- •- Serum transaminase =2 times the upper limit of normal
- •- Alkaline phosphatase levels =3 times the upper limit of normal
- •- Serum creatinine =150 µmol/L (=1.7mg/dL)
- •6.Subjects must have the ability to understand and comply with instructions and be able to complete study-related forms and questionnaires.
- •7.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.
- •8.Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
- •Note-Female patients of child bearing potential must agree to use adequate contraception during the study and continue at least six months after the last dose of study drug. For this study, acceptable and effective methods of contraception for females include:
- •- Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period,
- •- Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or
- •- Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).
- •For males, adequate birth control methods suggested and defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
- •It is absolutely essential that patients are adequately counselled at the time of ICF and also, reminded at each visit that the use of birth control measures is mandatory.
排除标准
- •1.Patients who had disorders associated with abnormal bone metabolism including uncontrolled hyper- or hypothyroidism or Paget’s disease; untreated or symptomatic brain metastases.
- •2.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.
- •3.Patients with life expectancy <6 months.
- •4.Patient with severe renal impairment (creatinine clearance <30 mL/min) or receiving dialysis.
- •5.Patients with severe, untreated hypocalcaemia.
- •6.Patient with rare hereditary problems of fructose intolerance.
- •7.Ongoing treatment with bisphosphonates.
- •8.Patients on hormone replacement therapy for menopausal symptoms.
- •9.Hypersensitivity to the active substance or to any of the excipients of DenosuRelTM
- •10.Patient with invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery in last 6 months before screening), poor oral hygiene or other pre-existing dental disease
- •11.Current use or known history of systemic (injectable or oral) corticosteroid medication use in last 6 months before screening Visit i.e. Date of informed consent. Investigator will assess this criterion and decision to include such patient can be taken based on justification for use of these medications as a premedication ( <5 mg/day) and for short duration not greater than 5-7 days after approval from sponsor medical monitor.
- •12.Patients with planned radiation therapy to bone or surgery to bone.
- •13.Patients with current or previous osteonecrosis or osteomyelitis of the jaw, any planned invasive dental procedure during the study.
- •14.Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis etc.).
- •15.Current smoker or smoking history within 12 months prior to the Screening Visit.
- •16.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
- •17.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.
- •18.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.
- •19.Inability to comply with study and/or follow-up procedures.
- •20.Subjects who are HIV, HBsAg, HCV test positive.
- •21.Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulm
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