Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 2: C189- Malignant neoplasm of colon, unspecified Health Condition 3: C711- Malignant neoplasm of frontal lobe Health Condition 4: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis Health Condition 5: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung Health Condition 6: null- Metastatic colorectal cancer, Non-Squamous Non–Small Cell Lung Cancer, Glioblastoma, Metastatic Renal
Conditions
Interventions
Intervention1: Hetero-Bevacizumab Solution for intravenous infusion: 100 mg per 4 mL single-use vial and 400 mg per 16 mL single-use vial administered as per the prescribing information
Control Interv
Sponsors
Hetero Biopharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female adult patients, 18 years or older 2. Patients with solid malignancies indicated Bevacizumab as per physician’s discretion according to the prescribing information. 3. Patient judged to be at low risk for obstruction or perforation 4. Adequate hematological function: ANC = 1.5 x 10(9)/L; platelets = 100 x 10(9)/L, Hb = 9 g/dl 5. Major surgery, open surgical biopsy or significant traumatic injury at least 4 weeks before randomization. If post-operative, at least 4 weeks’ time after surgery and until the surgical wound is fully healed.
Exclusion criteria
Exclusion criteria: 1. Patients with serious hemorrhage or recent hemoptysis. 2. Presence of a serious, non-healing wound, ulcer, or bone fracture 3. History of hemorrhagic diathesis or coagulopathy 4. Significant vascular disease (e.g., aortic aneurysm or dissection) or recent peripheral arterial thrombosis within 6 months prior to dosing, any peripheral vascular disease, or venous thrombo-embolic events within the past 3 months 5. Patients who are likely to be pregnant or lactating patients. 6. Patients with clinical history/evidence of allergy/ hypersensitivity to murine proteins or components of Hetero- Bevacizumab. 7. Patients with history or pre-existing clinical evidence of medically significant abnormality or requirements for surgery that precludes the usage of Hetero- Bevacizumab, as per investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity, outcome, duration, action taken, and causality of individual adverse events [Expected and Unexpected adverse events (Serious and Non-serious Adverse Events)] reported during the studyTimepoint: All time points | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity - development and change in antidrug antibodies (ADA) titer against Hetero-BevacizumabTimepoint: At screening, at the end of 6-8 cycles or at the end of study, if happens early and at the end of 12 months;Efficacy- Change in efficacyTimepoint: At the end of 6-8 cycles or at the end of study, if happens earlier | — |
Countries
India
Contacts
Public ContactDr SD Sinha
Hetero Drugs Limited
Outcome results
None listed