A clinical trial to study the safety and efficacy of biosimilar Bevacizumab in patients with metastatic colorectal cancer.

Phase 3

• Conditions: Health Condition 1: C189- Malignant neoplasm of colon, unspecified

• Registration Number: CTRI/2020/06/025851
• Lead Sponsor: Enzene Biosciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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

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) < 1,500/mm3

b. Hemoglobin (Hb) < 9 g/dL

c. Total Leucocyte count < 3000/mm3

d. Platelet count < 100,000/mm3

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified