Health Condition 1: null- patients with metastatic ColoRectal Cancer (mCRC)
Conditions
Interventions
Intervention1: Bevacizumab
Biosimilar: Bevacizumab (5 mg/kg) will be administered initially as a 90-minute infusion
Control Intervention1: AVASTIN (Roche/Genentech: Avastin® (5 mg/kg) will be adminis
Sponsors
MABXIENCE SA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must have signed an informed consent before any study related procedure or evaluation is performed. 2. Patients must be > 18 years of age. 3. Patient must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy. 4. Patient with mCRC for whom bio-chemotherapy is indicated. 5. Patients must have at least one measurable non-irradiated site of disease according to RECIST criteria. 6. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy. 7. ECOG performance status <= 2.
Exclusion criteria
Exclusion criteria: 1. Prior treatment for advanced or metastatic colorectal cancer. 2. Prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting. 3. Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment). 4. History of any other malignancy unless the malignancy is in complete remission and the patient has been off all therapy for that malignancy for at least 5 years. 5. Chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed. 6. Scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry. 7. Uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases. 8. Patients with active bleeding or history of bleeding diathesis on oral anti-vitamin K medication (except low dose coumadin) within the past 6 month prior to randomization or coagulopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the PK profile of Bevacizumab and Avastin®, both administered in combination with FOLFOX (any) or FOLFIRI.Timepoint: Cycle 1: 0 h(pre-infusion), end of infusion; 1 h, 2 h, 6 h, 24 h (D2), 48h (D3),72h (D4), 120h (D6), 168 h (D8) & 240 h (D11) after end of infusion.Cycle 2- Cycle 5: 0 h(pre-infusion), end of infusion on D1 of Cycles 2 and 5 Cycle 7: 0h, end of infusion; 1 h, 2 h, 6 h after end of infusion on D1 and thereafter one sample at 24 h (D2), 48 h (D3), 72 h (D4), 120 h (D6), 168 h (D8), 240 h (D11) after end of infusion (Cycle 7)and 336 h(D15, just before the start of the bevacizumab of Cycle 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparation the safety profile of Bevacizumab and Avastin®, both administered in combination with FOLFOX (any) or FOLFIRI.Timepoint: At the End of study. i.e. After 12 months. | — |
Countries
Argentina, Brazil, India, Peru, Russian Federation, Ukraine
Contacts
Public ContactDr Chirag Shah
Cliantha Research Limited
Outcome results
None listed