- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03206151
CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer
Open, Randomized, Controlled, Multicenter Phase III Study Comparing CMAB009 Plus FOLFIRI Versus FOLFIRI Alone as First-line Treatment for Epidermal Growth Factor Receptor-expressing, RAS/BRAF Wild-type, Metastatic Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomly assign in one of the two groups to either receive the combination chemotherapy alone or with CMAB009 and will then be treated until progression of the disease or unacceptable toxicity occurred. Regular efficacy assessments(every 8 weeks)based on imaging will be performed throughout the study together with regular safety assessments.
After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100021
- Cancer Hospital Chinese Academy of Medical Sciences
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Tianjin
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Tianjin, Tianjin, China, 300000
- Tianjing Medical University Cancer Institute and Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males or females, Aged ≥18 years and ≤75 years
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- First occurrence of metastatic disease(not curatively resected)
- RAS/BRAF wild-type status in tumor tissue
- At least one measurable lesion by computer tomography(CT) or magnetic resonance imaging (MRI)according to RECIST1.1 criteria (not in an irradiated area)
- Eastern Cooperative Oncology Group(ECOG)performance status of 0 or 1 at trial entry
- Life expectancy of at least 3 months
- Medically accepted effective contraception if procreative potential exists(applicable for both male and female subjects until at least 90 days after the last dose of trial treatment)
- Recovery from relevant toxicity due to previous treatment before trial entry
- Signed the informed consent form voluntarily
Exclusion Criteria:
- Radiotherapy or surgery(excluding prior diagnostic biopsy)in the 30 days before trial treatment
Hepatic, marrow, liver and renal function as follows:
Marrow: white blood cell count <3.0 × 109/L with neutrophils<1.5 × 109/L, platelet count<100×109/L and hemoglobin<90 g/L; Liver function: Total bilirubin >1.5 × upper limit of reference range; Aspartate transaminase (AST) and alanine transaminase (ALT) > 2.5 × upper limit of reference range , or> 5 × upper reference range in subjects with liver metastasis; Renal function: Serum creatinine >1.5 × upper limit of reference range, or creatinine clearance<50 mL/min
- Previous chemotherapy for CRC adjuvant treatment if terminated <12 months before diagnosis of recurrence or metastatic disease
- Previous treatment with anti-EGFR monoclonal antibody, epidermal growth factor receptor tyrosine kinase inhibitor, or other EGFR targeted inhibitors(such as cetuximab, Nimotuzumab, or panitumumab)
- Known hypersensitivity or allergic reactions against any of the components of the trial treatments
- History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
- Other non-permitted concomitant anti-cancer therapies
- Known brain metastasis and/or leptomeningeal disease
- Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
- Participation in another clinical trial within the past 30 days
- Concurrent chronic systemic immune therapy or hormone therapy except physiologic replacement
- Any unstable systemic disease, such as active infection, uncontrolled hypertension, unstable angina pectoris, angina in the last 3 months, cardiac failure of New York Heart Association classes ≥II, history of myocardial infarction, serious cardiac arrhythmias that require drug treatment, liver, kidney or metabolic disease in the last 6 months
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- severe bone marrow function failure
- Any disease, metabolic disorders, or physical/laboratory examination suspected, or patients with high risk of complications
- Known and declared history of human immunodeficiency virus(HIV)infection
- HBV-DNA >1.0 × 103copy
- Pregnancy or breastfeeding
- Alcohol or drug abuse
- Legal incapacity or limited legal capacity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CMAB009 + FOLFIRI
Drug: CMAB009(recombinant chimeric anti-EGFR monoclonal antibody injection), will be administered every 7 days at an initial dose of 400mg/m^2 and 250mg/m^2 for subsequent infusions until progression of disease , withdrawal of consent, or unacceptable toxicity. Drug: Irinotecan bi-weekly irinotecan infusion of 180mg/m^2 on Day 1. Drug: Folinic Acid infusion 400mg/m^2 of folinic acid in on Day 1. Drug: 5-Fluorouracil bolus 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-48 h continuous infusion of 2400mg/m^2. every 2 weeks until progression of disease , withdrawal of consent, or unacceptable toxicity. |
for injection only
Other Names:
for injection only
Other Names:
for injection only
Other Names:
for injection only
Other Names:
|
Active Comparator: FOLFIRI
FOLFIRI Drug: Irinotecan bi-weekly irinotecan infusion of 180mg/m^2 on Day 1. Drug: Folinic Acid infusion 400mg/m^2 of folinic acid in on Day 1. Drug: 5-Fluorouracil bolus 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-48 h continuous infusion of 2400mg/m^2. every 2 weeks until progression of disease , withdrawal of consent, or unacceptable toxicity. |
for injection only
Other Names:
for injection only
Other Names:
for injection only
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: Baseline up to 24 months
|
Defined as the duration from randomization until the date of first documented progression or date of death from any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later.
Progressive disease assessed by RECIST1.1
|
Baseline up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Overall Response Rate(ORR)
Time Frame: Baseline up to 24 months
|
Defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response based on RECIST1.1
|
Baseline up to 24 months
|
Overall Survival Time (OS)
Time Frame: Baseline up to 48 months
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Defined as the time from randomization to death
|
Baseline up to 48 months
|
Duration of Response
Time Frame: Baseline up to 24 months
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Defined as the time from first assessment of CR or PR to disease progression or death
|
Baseline up to 24 months
|
Number of Subjects with Curative Surgery of Liver Metastases
Time Frame: Baseline up to 12 months
|
Defined as the number of subjects who underwent liver metastatic surgery with all lesions been resected completely after start of treatment
|
Baseline up to 12 months
|
Quality of Life Assessment
Time Frame: Baseline up to 24 months
|
EORTC-QLQ-C30
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Baseline up to 24 months
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Pharmacokinetic Parameters
Time Frame: Baseline up to 50 days
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Area under the curve and the Maximum concentration of CMAB009
|
Baseline up to 50 days
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Incidence of anti-CMAB009 antibody
Time Frame: baseline up to 32 weeks
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The incidence rate of ADA (anti-CMAB009 antibody)and Nab(neutralizing antibody)
|
baseline up to 32 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yuankai Shi Professor, Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Principal Investigator: Yi Ba Professor, Ph.D, Tianjin Medical University Cancer Institute & Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Micronutrients
- Vitamins
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Hematinics
- Fluorouracil
- Leucovorin
- Irinotecan
- Levoleucovorin
- Folic Acid
Other Study ID Numbers
- 009mCRCIIIP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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