Metastatic Colorectal CancerPhase 3NCT03391934
Comparing Efficacy and Safety of Cetuximab (CinnaGen) Versus Erbitux® (Merck) in Metastatic Colorectal Cancer
A Phase 3 study testing Cetuximab + FOLFIRI in people with Metastatic Colorectal Cancer, run by Cinnagen at 1 site in Iran.
Trial summary
The study is designed as phase III, randomized, two armed, parallel, double blind (patient and assessor blinded), active controlled, and equivalency clinical trial with primary endpoint of Progression-Free Survival of Cetuximab® (produced by CinnaGen) compared with Erbitux® (Cetuximab, the reference drug) in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Cetuximab + FOLFIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteIran
- Study dates
- 20 Jan 2018to 1 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Taleqani Hospital
Tehran
Somayeh Amini, Pharm D, 00982143473000, amini.s@orchidpharmed.com
Morteza Azhdarzadeh, Pharm D, 00982143473000, azhdarzadeh.m@orchidpharmed.com
About this study
Official 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
The study is designed as phase III, randomized, two armed, parallel, double blind (patient and assessor blinded), active controlled, and equivalency clinical trial with primary endpoint of Progression-Free Survival of Cetuximab® (produced by CinnaGen) compared with Erbitux® (Cetuximab, the reference drug) in patients with RAS wild-type Metastatic Colorectal Cancer with the allocation ratio of 2:1.Patients who met the following criteria could be recruited to receive the mentioned intervention randomly. 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
Read the detailed description
The study is designed as phase III, randomized, two armed, parallel, double blind (patient and assessor blinded), active controlled, and equivalency clinical trial with primary endpoint of Progression-Free Survival of Cetuximab® (produced by CinnaGen) compared with Erbitux® (Cetuximab, the reference drug) in patients with RAS wild-type Metastatic Colorectal Cancer with the allocation ratio of 2:1.Patients who met the following criteria could be recruited to receive the mentioned intervention randomly. 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
Patients who have 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 will be excluded from the study. Also, female patients who are pregnant or lactating, and 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, and patients with inability to comply with the study and/or follow up procedures will be excluded.The primary endpoint of the study is Progression-Free Survival (PFS) defined as the time from randomization to disease progression or death from any cause. The secondary endpoints of the study are Overall Survival (OS) defined as the time from date of randomization to date of death due to any cause, Objective Response Rate (ORR) defined as the sum of partial and complete responses, according to RECIST criteria and Time to Treatment Failure (TTF) is defined 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 cells, The tumor either became larger (disease progression) or stayed the same size after treatment, Discontinuation of treatment, Death from any cause
Safety and Immunogenicity will also be assessed during the study.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Cetuximab + FOLFIRI
- Keywords
- RAS Wild-type, Cetuximab, Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab + FOLFIRIDrug
Also called FOLFIRI = irinotecan + calcium folinate + 5-fluorouracil
Cetuximab 400 mg/m2 will be administered in the first dose and 250 mg/m2 will be administered in the next doses every week. Irinotecan will be administered 180 mg/m2 biweekly. Leucovorin will be administered 400 mg/m2 biweekly.Fluorouracil will be administered 400 mg/m2 push, and 2400 mg/m2 as 46-h infusion biweekly.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab+ FOLFIRI | Experimental | Cetuximab (Produced by CinnaGen Co.): 400 mg/m2 weekly in the first dose and 250 mg/m2 in the next doses Irinitecan: 180 mg/m2 biweekly Leucovorin: 400 mg/m2 biweekly Fluorouracil: 400 mg/m2 push, and 2400 mg/m2 as 46-h infusion biweekly Receives: Drug: Cetuximab + FOLFIRI |
| Cetuximab + FOLFIRI | Active comparator | Erbitux® (Produced by Merk Co.): 400 mg/m2 weekly Irinitecan: 180 mg/m2 biweekly Leucovorin: 400 mg/m2 biweekly Fluorouracil: 400 mg/m2 push, and 2400 mg/m2 as 46-h infusion biweekly Receives: Drug: Cetuximab + FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
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.
Measured: 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 outcomes (5)
Overall Survival (OS)
Overall survival OS is defines as the time from date of randomization to date of death due to any cause
Measured: 26 weeks after study start
Objective Response rate
Tumor response was defined as partial and complete responses, according to the RECIST criteria.
Measured: 26 weeks after study start
Time of treatment failures
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
Measured: 26 weeks after study start
Adverse events
Safety wills assess on the basis of reports of adverse events, laboratory-test results, and vital sign measurements. Adverse events were categorized According to the Common Toxicity Criteria of the National Cancer Institute, version 4.0, in which a grade of 1 indicates mild adverse events, a grade of 2 moderate adverse events, a grade of 3 serious adverse events, and a grade of 4 life-threatening adverse events
Measured: 26 weeks after study start
immunogenicity
antidrug antibody [ADA] and neutralizing antibody [nAb] assessment
Measured: 26 weeks after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start20 Jan 2018
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cinnagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391934
- Sponsor's protocol ID
- CET.CIN.HR.96 (III)
- Status last verified
- Apr 2023
- First submitted
- 31 Dec 2017
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03391934
- Acronym / sponsor ID
- CET.CIN.HR.96 (III)
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- RAS Wild-type, Cetuximab, Metastatic Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- CinnagenIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed as phase III, randomized, two armed, parallel, double blind (patient and assessor blinded), active controlled, and equivalency clinical trial with primary endpoint of Progression-Free Survival of Cetuximab® (produced by CinnaGen) compared with Erbitux® (Cetuximab, the reference drug) in patients with RAS wild-type Metastatic Colorectal Cancer with the allocation ratio of 2:1.Patients who met the following criteria could be recruited to receive the mentioned intervention randomly. 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
Detailed description
The study is designed as phase III, randomized, two armed, parallel, double blind (patient and assessor blinded), active controlled, and equivalency clinical trial with primary endpoint of Progression-Free Survival of Cetuximab® (produced by CinnaGen) compared with Erbitux® (Cetuximab, the reference drug) in patients with RAS wild-type Metastatic Colorectal Cancer with the allocation ratio of 2:1.Patients who met the following criteria could be recruited to receive the mentioned intervention randomly. 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
Patients who have 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 will be excluded from the study. Also, female patients who are pregnant or lactating, and 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, and patients with inability to comply with the study and/or follow up procedures will be excluded.The primary endpoint of the study is Progression-Free Survival (PFS) defined as the time from randomization to disease progression or death from any cause. The secondary endpoints of the study are Overall Survival (OS) defined as the time from date of randomization to date of death due to any cause, Objective Response Rate (ORR) defined as the sum of partial and complete responses, according to RECIST criteria and Time to Treatment Failure (TTF) is defined 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 cells, The tumor either became larger (disease progression) or stayed the same size after treatment, Discontinuation of treatment, Death from any cause
Safety and Immunogenicity will also be assessed during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetuximab+ FOLFIRI | Experimental | Drug: Cetuximab + FOLFIRICetuximab (Produced by CinnaGen Co.): 400 mg/m2 weekly in the first dose and 250 mg/m2 in the next doses Irinitecan: 180 mg/m2 biweekly Leucovorin: 400 mg/m2 biweekly Fluorouracil: 400 mg/m2 push, and 2400 mg/m2 as 46-h infusion biweekly |
| Cetuximab + FOLFIRI | Active comparator | Drug: Cetuximab + FOLFIRIErbitux® (Produced by Merk Co.): 400 mg/m2 weekly Irinitecan: 180 mg/m2 biweekly Leucovorin: 400 mg/m2 biweekly Fluorouracil: 400 mg/m2 push, and 2400 mg/m2 as 46-h infusion biweekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab + FOLFIRIAlso: FOLFIRI = irinotecan + calcium folinate + 5-fluorouracilCetuximab 400 mg/m2 will be administered in the first dose and 250 mg/m2 will be administered in the next doses every week. Irinotecan will be administered 180 mg/m2 biweekly. Leucovorin will be administered 400 mg/m2 biweekly.Fluorouracil will be administered 400 mg/m2 push, and 2400 mg/m2 as 46-h infusion biweekly. | Drug | Cetuximab + FOLFIRI, Cetuximab+ FOLFIRI |
Primary outcome
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
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.
5 secondary outcomes
Overall Survival (OS)
Time frame: 26 weeks after study start
Objective Response rate
Time frame: 26 weeks after study start
Time of treatment failures
Time frame: 26 weeks after study start
Adverse events
Time frame: 26 weeks after study start
immunogenicity
Time frame: 26 weeks after study start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- This protocol is planned to be registered according to program in Iran Registry of Clinical Trial (IRCT).Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetuximab + FOLFIRI in people with Metastatic Colorectal Cancer, run by Cinnagen at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Somayeh Amini, Pharm D (00982143473000, amini.s@orchidpharmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.