Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site
Conditions
Interventions
Intervention1: IV bevacizumab 10-15 mg/kg of Intas Pharmaceuticals Limited, India: Dose: 10-15 mg/kg
Frequency: every 2 to 3
weekly
Mode of Administration: Intravenous injection via infusion
Duration of treatment: 6 Cycles
Control Intervention1: NA: NA
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 ( 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the safety and tolerability of bevacizumabTimepoint: Visit 1 to visit 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the efficacy and immunogenicity of bevacizumabTimepoint: At the end of 6th cycle. | — |
Countries
India
Contacts
Public ContactMr Sumanta Nandi
Lambda Therapeutic Research Ltd
Outcome results
None listed