Status:
COMPLETED
Comparing Efficacy and Safety of Stivant (AryoGen Bevacizumab) Versus Avastin in Metastatic Colorectal Cancer
Lead Sponsor:
AryoGen Pharmed Co.
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a Phase III, randomized, two arms, double-blind (patient and assessor blinded), parallel active non inferiority controlled clinical trial with a 2:1 allocation. This trial was conducted to eva...
Detailed Description
This is a Phase III, randomized, two arms, double-blind (patient and assessor blinded), parallel active non inferiority controlled clinical trial with a 2:1 allocation. This trial was conducted to eva...
Eligibility Criteria
Inclusion
- Are male or female aged 18-75 years at the time of signing the informed consent form.
- Have been diagnosed as mCRC verified histologically
- Having one or more bi-dimensionally measurable lesions as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria,
- Was not felt to be amenable to curative resection,
- With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Life expectancy of longer than 3 months ( clinical assessment)
- Adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) greater than/equal to 1,500/mm3;
- Platelets greater than/equal to 100,000/ mm3;
- Hemoglobin greater than/equal to 9 gm/dl (may be transfused to maintain or exceed this level);
- Total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);
- Aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) less than/equal to 2.5 times IULN, or less than/equal to 5 times IULN if known liver metastases;
- May have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent disease was documented
- Patients with history of hypertension must be well-controlled (blood pressure less than/equal to 150/100), on a stable regimen of anti-hypertensive therapy.
Exclusion
- Prior targeted therapy for mCRC
- Radiotherapy or surgery for mCRC less than 4 weeks before random assignment.
- Undergone major surgical procedures or open biopsy within 28 days before the initiation of study treatment
- Experienced significant traumatic injury, within 28 days before study entry
- Currently using or had recently used therapeutic anticoagulants, thrombolytic therapy, chronic, daily treatment with aspirin (higher than 325 mg/daily). (Patients may have prophylactic use of low molecular weight heparin, however therapeutic use of heparin or low molecular weight heparin is not acceptable)
- Proteinuria exceeding 500mg/24 h
- History or presence of central nervous system metastases
- Female patients who are pregnant or lactating
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan, 5-FU, or leucovorin
- Serious non-healing wound, ulcer, or active bone fracture
- Myocardial infarction within 6 months before of study enrollment;
- History of stroke within 6 months before of study enrollment;
- Clinically significant peripheral vascular disease;
- Uncontrolled diabetes; Serious active or uncontrolled infection
- Inability to comply with study and/or follow-up procedures
Key Trial Info
Start Date :
October 4 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2018
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03288987
Start Date
October 4 2016
End Date
July 30 2018
Last Update
January 22 2021
Active Locations (22)
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1
Shafa Hospital
Ahvāz, Iran
2
Shahid Beheshti Hospital
Hamadan, Iran
3
Saba Clinic
Isfahan, Iran
4
Sheikh Mofid
Isfahan, Iran