Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 2: C189- Malignant neoplasm of colon, unspecified Health Condition 3: C569- Malignant neoplasm of unspecifiedovary Health Condition 4: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: DRL_BZ (Dr Reddys Bevacizumab): Dose and frequency:
1). mCRC: 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 week
Sponsors
Dr Reddys Laboratories ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 ââ?°Â¥ 6 months, as per Investigatorââ?¬•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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Incidence of adverse events (AEs) and serious adverse events (SAEs)Timepoint: from enrollment till EOS including unscheduled visits | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the Overall Response Rate (ORR, RECIST 1.1 criteria) and Disease Control Rate (DCR, RECIST 1.1. criteria)Timepoint: from cycle 1 to EOS | — |
Countries
India
Contacts
Public ContactMr Prasad Govind Hande
Dr. Reddy�s Laboratories Ltd.
Outcome results
None listed