Comparing Efficacy and Safety of Cetuximab (CinnaGen) Versus Erbitux® (Merck) in Metastatic Colorectal Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 April 2023
• Main ID: NCT03391934
• Date of registration: 31/12/2017
• Prospective Registration: Yes
• Primary sponsor: Cinnagen
• Public title: Comparing Efficacy and Safety of Cetuximab (CinnaGen) Versus Erbitux® (Merck) in Metastatic Colorectal Cancer
• Scientific title: A Phase III, Randomized, Two-armed, Parallel, Double-blind, Active-controlled, Equivalency Clinical Trial of Cetuximab (CinnaGen Co.) Efficacy and Safety Compared With Erbitux (Merck Co.) and FOLFIRI for RAS Wild-type mCRC
• Date of first enrolment: January 20, 2018
• Target sample size: 234
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03391934
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Iran, Islamic Republic of

Contacts

• Name: Somayeh Amini, Pharm D

• Name: Somayeh Amini, Pharm D

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female older than 18 years old

- Histologically confirmed adenocarcinoma of the colon or rectum which is metastatic

- Having one or more bi-dimensionally measurable lesions as defined by RECIST criteria

- Tumor that could not be resected for curative purposes

- ECOG performance status score of 2 or less

- Life expectancy of longer than 3 months (clinical assessment)

- Evidence of tumor EGFR expression (expanded wild-type RAS)

- Adequate organ and marrow function as defined:

ANC = 1,500/mm3 Plt = 100,000/mm3 Hb = 9 g/dL (may have had blood transfusions) AST/ALT =
2.5 IULN or = 5 IULN with known liver metastases Total bilirubin = 1.5 IULN Serum
Creatinine = 1.5 IULN INR = 1.5 and PTT = 1.5 IULN

Exclusion Criteria:

- Previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy

- Radiotherapy, surgery (excluding previous diagnostic biopsy), or any investigational
drug in the 30-day period before the start of treatment in our trial

- Female patients who are pregnant or lactating

- Patients with any history of another primary malignancy in the past five years, with
the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix

- Patients with history of allergic reactions attributed to compounds of similar
chemical or biologic drugs as cetuximab, irinotecan, fluorouracil or leucovorin

- Adjuvant treatment that was terminated 6 months or less before the start of treatment
in our trial

- Inability to comply with study and/or follow-up procedures.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Metastatic Colorectal Cancer

Intervention(s)

Drug: Cetuximab + FOLFIRI

Primary Outcome(s)

Progression Free Survival (PFS) [Time Frame: PFS was measured from the start of chemotherapy to the date of disease progression or to the date of death if no progression whichever came first, assessed up to 26 weeks]

Secondary Outcome(s)

Objective Response rate [Time Frame: 26 weeks after study start]

Overall Survival (OS) [Time Frame: 26 weeks after study start]

Adverse events [Time Frame: 26 weeks after study start]

immunogenicity [Time Frame: 26 weeks after study start]

Time of treatment failures [Time Frame: 26 weeks after study start]

Secondary ID(s)

CET.CIN.HR.96 (III)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors