Comparing Efficacy and Safety of Stivant (AryoGen Bevacizumab) Versus Avastin in Metastatic Colorectal Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

October 4, 2016

Primary Completion Date

July 30, 2018

Study Completion Date

July 30, 2018

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Bevacizumab + FOLFIRI-3

Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent.

Trial Locations (22)

Unknown

Shafa Hospital, Ahvāz

Shahid Beheshti Hospital, Hamadan

Saba Clinic, Isfahan

Sheikh Mofid, Isfahan

Payandeh Clinic, Kermanshah

Shazad Clinic, Kermanshah

Imam Reza Hospital, Mashhad

Qaem Hospital, Mashhad

Rasool Hospital, Rasht

Razi Hospital, Rasht

Namazi Hospital, Shiraz

Firoozgar Hospital, Tehran

Imam Khomeini Hospital, Tehran

Imam Reza Hospital (501 Artesh), Tehran

Masih Daneshvari Hospital, Tehran

Masoud Internal Clinic, Tehran

Safa najafi clinic, Tehran

Shariati Hospital, Tehran

Sina Hospital, Tehran

Taleqani Hospital, Tehran

Mortazavizadeh Clinic, Yazd

Seyedshohada Hospital, Yazd

Sponsors
All Listed Sponsors
lead

AryoGen Pharmed Co.

INDUSTRY