CTRI/2017/12/010893招募中4 期
An Open Label, Single Arm, Multicentric, Phase IV study to evaluate the safety and efficacy of Bevacizumab of Intas Pharmaceuticals Limited in approved indications. - NA
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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. Patient suffering from suffering from Metastatic carcinoma of the colon or rectum or Metastatic breast cancer or Unresectable advanced, metastatic or recurrent, Non-squamous non-small cell lung cancer or Advanced or Metastatic renal cell carcinoma (mRCC) or Advanced epithelial ovarian, fallopian tube or primary peritoneal cancer as Front line treatment, Platinum sensitive recurrent disease or Platinum-resistant recurrent disease or Persistent, recurrent, or metastatic carcinoma of the cervix1
- •2. At-least one measurable lesion according to Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1) criteria.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status ï?£2.
- •4. Patients with adequate haematopoietic and liver function
- •5. Patients must have adequate renal function
- •6. Patients with a history of hypertension has to be well-controlled ( <140/90 mmHg) on a stable regimen of anti-hypertensive therapy
- •7. No immunomodulatory, hormonal or radiation therapy within last three months from day of enrolment
- •8. Patient should have recovered from any toxic effects of previous chemotherapy or radiotherapy and has no so safety concerns as judged by the Investigator.
- •9. Patient with life expectancy of at least 6 months (or more) as judged by the Investigator.
- •10. Women of childbearing potential and sexually active males must agree to use an acceptable and effective method of contraception (hormonal or barrier methods) prior to study entry (a method which has low failure rate) and for the duration of the study
- •11. Patients who understand the investigational nature of this study and gives written informed consent prior to the participation in the trial.
- •12. Able to comply with study requirement in opinion of Principal Investigator.
排除标准
- •1. Prior treatment with bevacizumab
- •2. Patient who is EGFR or ALK positive
- •3. Pregnant and lactating women
- •4. Patients with history of gross haemoptysis
- •5. Patient with known brain metastases.
- •6. Patients with non-healing wound ulcer, bone fracture, major surgical procedure performed, open biopsy or significant traumatic injury within last 28 days OR anticipation of need for major surgical procedure during the course of the study
- •7. Patients with NYHA Grade II (or more severe) cardiac diseases which are clinically significant
- •8. Uncontrolled hypertension
- •9. Patient with ongoing or active infection(s).
- •10. History of thrombotic events like stroke, active symptomatic peripheral vascular disease within last 6 months
- •11. Evidence of bleeding diathesis or coagulopathy.
- •12. Patients receiving chronic antiplatelet or
- •anticoagulant therapy
- •13. Known hypersensitivity to any components of the study medications and excipients
- •14. Receipt of an investigational product, or participation in a drug research study within a period of 30 days prior to the planned first dose of investigational Product
研究者
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