CTRI/2018/06/014501进行中（未招募）3 期
Prospective, multi-center, randomized, double-blind,two-arm, parallel group, active control, comparativeclinical study to evaluate efficacy and safety of R-TPR-045 / Xgeva® for prevention of skeletal related events inpatients with bone metastases from solid tumours
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
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. Males and females patients of >=18 -65 years of age.
- •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 >=9.0 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 <=2 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.
排除标准
- •1. Patients with multiple myeloma
- •2. Patients who had disorders associated with abnormal bone metabolism including
- •uncontrolled hyper- or hypothyroidism or Pagetâ??s disease; untreated or symptomatic
- •brain metastases
- •3. 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
- •4. Patients with life expectancy <6 months
- •5. Patient with severe renal impairment (creatine clearance <30 mL/min) or receiving
- •6. Patients with severe, untreated hypocalcaemia
- •7. Patient with rare hereditary problems of fructose intolerance
- •8. Prior use of Denosumab or ongoing treatment with bisphosphonates.
- •9. Patients on hormone replacement therapy for menopausal symptoms.
- •10. Hypersensitivity to the active substance or to any of the excipients
- •11. 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
- •12. Current use or known history of systemic (injectable or oral) corticosteroid medication
- •use in last 6 months before screening Visit.
- •13. Patients with planned radiation therapy or surgery to bone
- •14. Patients with current or previous osteonecrosis or osteomyelitis of the jaw, any
- •planned invasive dental procedure during the study
- •15. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive
- •pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis etc.).
- •16. Current smoker or smoking history within 12 months prior to the Screening Visit.
- •17. 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
- •18. 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
- •19. 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.
- •20. Inability to comply with study and/or follow-up procedures.
- •21. Subjects who are HIV, HBsAg, HCV test positive.
- •22. 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 participati
研究者
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