]>
IRCT2017110821315N10 IRCT 2017-11-15 CinnaGen company An equivalency clinical trial to determine the efficacy and safety between Cetuximab (produced by CinnaGen) compared with Erbitux® in RAS wild-type Metastatic Colorectal Cancer A Phase III, randomized, two armed, parallel, double blind, active controlled, equivalency clinical trial to determine the therapeutic efficacy and safety between Cetuximab (produced by CinnaGen) and FOLFIRI compared with Erbitux® (Cetuximab, the reference drug, produced by Merck Company) and FOLFIRI as first-line treatment for RAS wild-type Metastatic Colorectal Cancer 2017-11-30 anticipated 234 Complete https://irct.ir/trial/18716 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be assigned to treatment with the use of a dynamic randomization algorithm that will be designed to achieve overall balance between groups; randomization will be stratified according to site of primary tumor and number of metastasis (1 or more than 1) with 1:2 allocation ratio. After randomization procedure, a code will be allocated to each patient that will be used as patient identifier throughout the study. The assigned code will be denoted by 4 initials (corresponding to the 2 first letter of the first name, the 2 first letter of the first surname) and 3 numbers (center code). Moreover, the code described is followed by study unique identification consisting of first three letters of the generic name (which is CET-) and 3 numbers (corresponding to the randomization number), e.g. ABCD001CET-001. The randomization number will be assigned in a consecutive way. concealment process: Randomization will not be exposed to those conducting the study and will be provided in sealed opaque envelopes with successive numbers. The original paper of randomized remains in the CRO Trial and after checking eligibility criteria, the randomization code is given to the prescriber by telephone. Randomization will not be exposed to the trial executers and will be provided to the researcher of each center in non-transparent sealed envelopes, Blinding description: Both cetuximab products are indistinguishable for patients and health care providers. Since the route of administration is infusion, and the size and shape of the vial, cap, seal, aluminum and the color are quite similar, it is not possible to distinguish the type of brand from the appearance of vials and it will be possible to make patients blind about the treatment group which they have been allocated to. 3 RAS wild-type Metastatic Colorectal Cancer. Intervention 1: CinnaGen Cetuximab (produced by CinnaGen) 400 mg/m2 for the first infusion, then weekly intravenous infusions of 250 mg/m2, every week for 6 months. Intervention 2: Erbitux® 400 mg/m2 for the first infusion, then weekly intravenous infusions of 250 mg/m2, every week for 6 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is it is not yet known if there will be a plan to make this available
public Dr. Hamidreza Kafi
No 42, Attar St., Vanak Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1468813112 +98 21 4347 3000 Kafi.H@orchidpharmed.com Orchid Pharmed company scientific Dr Hamid Rezvani
AyatollahTaleghani Hospital, Shahid Erabi street. Yaman street, Shahid Chamran highway
Tehran Iran (Islamic Republic of) 1468813112 +98 21 2293 7031 hampegrad@gmail.com Shahid Beheshti university of medical sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) male or female Age of 18 till 75 histologically confirmed adenocarcinoma of the colon or rectum having one or more bi-dimensionally measurable lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria metastatic disease that could not be resected for curative purposes immunohistochemical evidence of tumor EGFR expression (expanded wild-type RAS) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less life expectancy of longer than 3 months (by clinical assessment) adequate organ and marrow function. 18 years 75 years Both Previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy the use of 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 a history of another primary malignancy in less than 5 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 chemically or biologically similar to Cetuximab, irinotecan, 5-FU 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 Subjects with known infection with HIV, HBV, HCV first line treatment in patient with right sided primary tumor C18.9, C20 Malignant neoplasm of colon, Malignant neoplasm of rectum Treatment - Drugs Treatment - Drugs CinnaGen Cetuximab (produced by CinnaGen) 400 mg/m2 for the first infusion, then weekly intravenous infusions of 250 mg/m2, every week for 6 months Erbitux® 400 mg/m2 for the first infusion, then weekly intravenous infusions of 250 mg/m2, every week for 6 months Assessment of Progression-Free Survival (PFS) time of Cetuximab and Erbitux®. Timepoint: a 12-month period. Method of measurement: PFS is defined as the time from the date of randomization to the first date of documentation progression (per investigator assessment) or death as a result of any cause. Overall survival. Timepoint: a 12-month period. Method of measurement: the time from date of randomization to date of death due to any cause. Objective response rate. Timepoint: a 12-month period. Method of measurement: RECIST criteria (Response Evaluation Criteria in Solid Tumors). Time to treatment failure. Timepoint: a 12-month period. Method of measurement: - Time of treatment failures define as the time from the date of randomization to the date of each of the following, - The treatment modalities did not destroy or modify the cancer cell. - The tumor either became larger (disease progression) or stayed the same size after treatment, - Death from any cause - Discontinuation of treatment. Safety and frequency of AEs. Timepoint: a 12-month period. Method of measurement: Safety wills assess on the basis of reports of adverse events, laboratory-test results, and vital sign measurements. Immunogenicity. Timepoint: Weeks 1, 2, 4, 10, 16, 22, 28, 34, 40 and 46. Method of measurement: assessment (antidrug antibody [ADA] and neutralizing antibody [nAb]). NCT03391934 ClinicalTrial.gov CinnaGen company Approved 2017-11-05 Shahid Beheshti University of Medical Science Tabnak St., Velenjak, Chamran High Way, Tehran Tehran Tehran Iran (Islamic Republic of) Approved 2017-10-15 Tabriz University of Medical science Tabriz University of Medical science,Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)