A prospective multicenter Open labelled Phase IV study to Establish the Safety & efficacy of Biosimilar Bevacizumab of Enzene Biosciences Ltd in Combination with Chemotherapy in Patients with Metastatic Colorectal Cancer
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enzene Biosciences Limited
- Enrollment
- 200
- Locations
- 7
- Primary Endpoint
- Treatment emergent serious and non-serious adverse events (AEs)
Study Overview
Brief Summary
A prospective, multicenter, Open labelled, Phase IV study to Establish the Safety & efficacy of Biosimilar Bevacizumab of Enzene Biosciences Ltd. in Combination with Chemotherapy in Patients with Metastatic Colorectal Cancer
Two Hundred (200) patients will be enrolled in the study.
The study shall consist of following periods.
Screening Period: It will last up to 21 days during which the patient will be assessed for eligibility in the study;
Treatment Period: It will either be 6 weeks with a 2-week therapy duration or 9 weeks with a 3-week therapy duration. Therapy will consist of 4 cycles of Biosimilar Bevacizumab with Chemotherapy regimen of Physicians choice;
Follow-up Period: 2 - 3 weeks after completion of Treatment Period depending on the chemotherapy regimen decided by the physician.
Primary Endpoint:
Treatment emergent serious and non-serious adverse events (AEs)
Alteration in clinical laboratory parameters
Secondary Endpoint
To evaluate the best overall response rate defined as proportion of patients achieving complete response [CR] or partial response [PR] as per response evaluation criteria in solid tumors (RECIST) version 1.1 at the EOS
To evaluate the Disease control rate defined as proportion of patients achieving complete response [CR] or partial response [PR] or stable disease [SD] as per response evaluation criteria in solid tumors (RECIST) version 1.1 at the EOS Change in ECOG at EOS
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •The subjects will be included in the study based on the following criteria Willing to provide voluntary written informed consent Male or Female subjects between 18 to 80 years of age (both inclusive) Has life expectancy of at least 6 months at the time of screening Histologically or cytologically confirmed metastatic colorectal cancer (Stage IV i.e. Metastatic disease, at least M1 as per AJCC TNM classification) Measurable disease (RECIST criteria version 1.1), based on radiographic studies performed prior to enrollment Eastern cooperative oncology group (ECOG) status 0 to 2 at the time of screening Willing and able to comply with the protocol.
Exclusion Criteria
- •Patient with potentially resectable metastatic disease as per investigator clinical judgment.
- •History of hemoptysis, thrombotic or hemorrhagic event in past 6 months History of wound healing complications.
- •Therapeutic anticoagulation, regular use of aspirin, NSAIDs or agents known to inhibit platelet function Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 28 days before enrollment Patients with major trauma within the 28 days before enrollment 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 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
- •History of active gastro duodenal ulcer within 4 weeks prior to screening Known hypersensitivity to any component of the investigational product and other medications used in this study Patients with a non-healed fracture History of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
- •Clinical evidence of brain metastasis or leptomeningeal involvement History of Interstitial Lung Disease or pulmonary fibrosis Patients with history of peripheral sensory neuropathy Patients with history of Rhabdomyolysis Patients with coagulopathy Myocardial infarction within 6 months prior to screening 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 Uncontrolled hypertension defined as systolic blood pressure more than 150 mm Hg and/or diastolic blood pressure more than 90 mm Hg despite medication and/or prior history of hypertensive emergencies Patients having the following laboratory results at screening Absolute neutrophil count (ANC) less than 1,500/mm3 Hemoglobin (Hb) less than 9 g/dL Total Leucocyte count less than 3000/mm3 Platelet count less than 100,000/mm3 Total bilirubin level more than 1.5 times the upper limit of the normal laboratory range (ULN) AST and ALT more than 1.5 x ULN (more than 5.0 x ULN if liver metastases are present) Alkaline phosphatase more than 2.5 x ULN (more than 5.0 x ULN if liver or bone metastases are present) Serum Creatinine level more than 1.25 x ULN INR and aPTT more than 1.5 x ULN Proteinuria: 3+ Patients suffering from acute or chronic infection(s) Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) at screening Patients who are not willing to use adequate contraception during the study period Female patients who are pregnant or nursing Has any concurrent disease or condition, which in the opinion of the investigator does not allow participation of the patient in this study Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening.
Outcomes
Primary Outcomes
Treatment emergent serious and non-serious adverse events (AEs)
Time Frame: Treatment emergent serious and non-serious adverse events (AEs) from Visit 1 to Visit 6 | Alteration in clinical laboratory parameter during the study period
Alteration in clinical laboratory parameter
Time Frame: Treatment emergent serious and non-serious adverse events (AEs) from Visit 1 to Visit 6 | Alteration in clinical laboratory parameter during the study period
Secondary Outcomes
- To evaluate the best overall response rate defined as proportion of patients achieving complete response [CR] or partial response [PR] as per response evaluation criteria in solid tumors (RECIST) version 1.1 at the EOS(To evaluate the Disease control rate defined as proportion of patients achieving complete response [CR] or partial response [PR] or stable disease [SD] as per response evaluation criteria in solid tumors (RECIST) version 1.1 at the EOS Change in ECOG at EOS)
Investigators
Dr Akhilesh Sharma
Alkem Laboratories Limited