Phase IV study of use of marketed KRABEVA®/Abevmy® in patients with compact growth forming cancers
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2019/02/017859
- Lead Sponsor
- Biocon Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 116
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method