Comparing Efficacy and Safety of Stivant (AryoGen Bevacizumab) Versus Avastin in Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2018-07-30
Target enrollment:
Participant gender:
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 evaluate the efficacy and safety of bevacizumab (produced by AryoGen
Pharmed) plus FOLFIRI-3 compared with bevacizumab (Avastin®) plus FOLFIRI-3 in patients with
metastatic colorectal cancer (mCRC). Patients who met the following criteria could be
recruited to receive the mentioned intervention randomly. Inclusion criteria: male or female
aged 18-75 years, 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 (ECOG) performance
status of ≤ 1, Life expectancy of longer than 3 months, Adequate organ and marrow function,
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.