A prospective, multi center, phase IV Study to Evaluate Safety and Efficacy of Dr Reddys Bevacizumab (DRL_BZ) in patients with Solid tumors.

Dr Reddys Laboratories ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Patients with solid tumours who require BZ treatment
•2. Established histopathologically/cytologically confirmed diagnosis of any of the above diseases with documented evidence of RECIST criteria version 1.1 [at least one measurable target lesion (other than lesions in the colon for non-resectable mCRC)];
•3. Willing to provide written informed consent indicating that they understand the purpose and are willing to participate in this study;
•4. Life expectancy Ã¢â?°Â¥ 6 months, as per InvestigatorÃ¢â?¬•s judgement;
•5. Patients, who the Investigator believes, can comply with requirements of this protocol;
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•7. Patients with adequate renal, liver and haematopoietic function;
•8. Women of childbearing potential and sexually active males must agree to use an acceptable and effective method of contraception (hormonal or barrier methods etc.) prior to study entry and for the duration of the study
•9. Patient should have recovered from any toxic effects of previous chemotherapy or radiotherapy and has no safety concerns as judged by the Investigator

•1. Prior treatment with bevacizumab
•2. Patient with known hypersensitivity to bevacizumab or to any of the excipients
•3. Patients participating or planning to participate in any other interventional drug study during the course of this study
•4. Patients with central nervous system metastases, history or evidence of clinically relevant non-neoplastic CNS disease.
•5. Patients having any medical condition or concurrent use of medications, which may be contraindication to the package insert as per the Investigators opinion

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