CTRI/2019/01/017364已完成3 期
Efficacy and safety of Intas Denosumab in comparison with Xgeva in patients with solid tumours with bone metastases
Intas Pharmaceuticals Ltd Biopharma Division0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
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. Adults with greater than or equal to 18 years.
- •2. Histological or Cytological confirmation of
- •a. Breast adenocarcinoma or
- •b. Prostate cancer or
- •c. Non-small cell lung cancer.
- •3. Radiographic evidence of at least 1 bone metastasis (Confirmed by X-ray, computed
- •tomography, magnetic resonance imaging or bone scan).
- •4. Eastern Cooperative Oncology Group performance status less than or equal to 2.
- •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 at least 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:
- •a. Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
- •b. Active dental or jaw condition which requires oral surgery.
- •c. Planned invasive dental procedure.
- •d. 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 less than or equal to 8 mg per dl.
- •8. Estimated creatinine clearance less than or equal to 30 ml per 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. Uncontrolled hypertension (Blood pressure more than 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 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 greater than or equal to 2.0 x upper limits of normal ULN
- •ii. ALT or SGPT greater than or equal to 2.0 x ULN
- •iii. Alkaline phosphatase and bilirubin greater than or equal to 1.5 x
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