Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: KRABEVA® /or AbevmyTM: Study Type:- INTERVENTION
Name:- KRABEVA® /or AbevmyTM
Details:- 100 mg per 4 mL single-use vial and /or 400 mg per 16 mL single-use vial administered as per th
Sponsors
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant, non-lactating females of age 18 years and above 2. Patients with indicated malignancies eligible to receive bevacizumab as per the prescribing information and judgement of the investigator 3. Adequate bone marrow, liver and renal function (judged by the investigator based on investigations at screening) 4. ECOG of 0, 1 or 2. 5. All women of child bearing potential (i.e., ovulating, pre-menopausal) should use at least 2 reliable forms of contraception during the trial.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to bevacizumab or other drugs required as part of treatment regimen for the malignancy. 2. History or presence of serious non-healing wound or active ulcer or untreated bone fracture. 3. Presence of or history of severe haemorrhage hemoptysis within 3 months prior to bevacizumab administration; significant gastrointestinal bleeding; intracranial hemorrhage or significant pathological vaginal bleeding. 4. Presence or history of severe arterial or venous thrombotic or thromboembolic events within the 6 months prior to first dose of bevacizumab in the trial. 5. History of gastrointestinal fistula/abscess/perforation or other fistula. 6. Tumor location known to be in close contact with major vessels, especially NSCLC 7. Presence of incompletely healed surgical wound at the time of first dosing of bevacizumab in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature and severity of adverse events causally related to bevacizumabTimepoint: Up to 6 months ( throughout the study) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients discontinuing Bevacizumab and/or chemotherapy /other cancer treatment due to adverse events related to bevacizumab. 2. Evaluation of efficacy parameters such as Progression Free Survival (PFS), Time to progression (TTP), Disease Control Rate (DCR), overall response rate (ORR), Duration of Response (DR) Timepoint: Up to 6 months | — |
Countries
India
Contacts
Public ContactJayanti Panda
Biocon Research Limited A subsidiary of Biocon Limited
Outcome results
None listed