Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Biosimilar Bevacizumab: Dosage Form: It will be supplied in concentration of 25 mg/ml single dose vial for injection Dose: 7.5 mg/kg intravenously every 3 weeks for a total of 4 cycles.
Sponsors
Enzene Biosciences Limited
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to provide voluntary written informed consent. 2. Male or Female subjects between 18 to 80 years of age (both inclusive) 3. Has life expectancy of at least 6 months at the time of screening 4. Histologically or cytologically confirmed metastatic colorectal cancer (Stage IV i.e. Metastatic disease, at least M1 as per AJCC TNM classification) 5. Treatment na�¯ve for mCRC 6. Measurable disease (RECIST criteria version 1.1), based on radiographic studies performed prior to randomization 7. Eastern cooperative oncology group (ECOG) status 0 to 2 at the time of screening 8. Willing and able to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Prior systemic chemotherapy (except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening). 2. Patient with potentially resectable metastatic disease as per investigatorââ?¬•s clinical judgment. 3. History of other malignancy within 5 years of screening 4. Prior use of Bevacizumab or another monoclonal antibody in the past 6 months prior to randomization 5. History of hemoptysis, thrombotic or hemorrhagic event in past 6 months 6. History of wound healing complications. 7. Therapeutic anticoagulation; regular use of aspirin, NSAIDs or agents known to inhibit platelet function 8. Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 28 days before randomization 9. Patients with major trauma within the 28 days before randomization or non-fully healed wound or any other clinically relevant wound or ulcer at the time of dosing or anticipated need for elective surgery during the study duration 10. History of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, diverticulitis or intra-abdominal abscess within the 6 months before screening or any chronic gastrointestinal disease causing diarrhea of a severity above CTCAE grade 1. 11. History of active gastro duodenal ulcer within 4 weeks prior to screening 12. Concomitant anti-tumor therapy or concomitant immunotherapy 13. Known hypersensitivity to any component of the investigational product and other medications used in this study 14. Patients with a non-healed fracture 15. History of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies. 16. Clinical evidence of brain metastasis or leptomeningeal involvement 17. History of Interstitial Lung Disease or pulmonary fibrosis 18. Patients with history of peripheral sensory neuropathy 19. Patients with history of Rhabdomyolysis 20. Patients with coagulopathy 21. Myocardial infarction within 6 months prior to screening 22. Symptomatic congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), unstable angina pectoris within 6 months prior to screening, significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year prior to screening 23. Uncontrolled hypertension defined as systolic blood pressure >150 mm Hg and/or diastolic blood pressure >90 mm Hg despite medication and/or prior history of hypertensive emergencies 24. Patientââ?¬•s having the following laboratory results at screening a. Absolute neutrophil count (ANC) b. Hemoglobin (Hb) c. Total Leucocyte count d. Platelet count e. Total bilirubin level > 1.5 times the upper limit of the normal laboratory range (ULN) f. AST and ALT > 1.5 x ULN ( > 5.0 x ULN if liver metastases are present) g. Alkaline phosphatase > 2.5 x ULN ( > 5.0 x ULN if liver or bone metastases are present) h. Serum Creatinine level > 1.25 x ULN i. INR and aPTT > 1.5 x ULN j. Proteinuria: 3+ 25. Patients suffering from acute or chronic infection(s) 26. Positive serology for human immunodeficiency virus (HIV), hepatitis B v
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of Biosimilar Bevacizumab versus Innovator Bevacizumab, both in Combination with CAPEOX in patients with metastatic colorectal cancer (mCRC) by assessment of best Overall Response Rate (ORR)Timepoint: All patients completed 12 week of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the following: 1. Disease Control Rate (DCR) 2. Pharmacokinetics (PK) of Biosimilar versus Innovator Bevacizumab 3. Immunogenicity of Biosimilar Bevacizumab and Innovator Bevacizumab by assessment of anti- Bevacizumab antibody 4. Safety and tolerability of the investigational product.Timepoint: 1. All patients completed 12 week of treatment. 2. Anti-Bevacizumab antibody (ADA): Baseline and Week 12 visit 3. PK Assessment:Baseline | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratoroes Limited
Outcome results
None listed