- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04810585
Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer
Efficacy and Biomarker Exploration of 2nd Line Aflibercept in Combination With FOLFIRI in Advanced Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, multicenter, open-label, single arm study. Patients will be considered "on study" upon signing the written informed consent form (ICF). The study consists of a baseline period, followed by a treatment period, consisting of 14-day treatment cycles, which will end by a 30-day Follow-up visit, which in turn, will be followed by a post-treatment follow-up period.
Patients will be evaluated for PFS then be followed on study until death or until cut-off date for final analysis of OS has been reached, whichever comes first.
During the 21-day baseline period, all baseline procedures will have to be performed within defined timelines, including review of eligibility criteria During the treatment period, the study treatment, aflibercept combined with FOLFIRI will be administered every 2 weeks unless a definitive treatment discontinuation criterion is met. Cycle lengths may be extended in case of unresolved toxicity.
Imaging to document tumor response and progressive disease will take place every 6 weeks and will continue to be done during the follow-up period in case of early study treatment discontinuation (i.e. prior to documented progression). Once disease progression is documented, patients will be followed every 2 months for survival status and collection of data regarding further anticancer therapy, until death or until the study cutoff date, whichever comes first.
The patients will be followed for safety for a minimum of 30 days following the last administration of the study treatment (30-day Follow-up visit). Beyond this date, all study drug related AEs and all SAEs should be followed until resolution/stabilization. Study drug-related AEs brought to the attention of the investigator at any time after the 30-day Follow-up visit should be recorded in the case report form (CRF).
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Joong Bae Ahn, MD, PhD
- Phone Number: 82-2-2228-8134
- Email: vvswm513@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Yonsei University
-
Contact:
- Joong Bae Ahn, MD, PhD
- Phone Number: 02-2228-8134
- Email: vvswm513@yuhs.ac
-
Principal Investigator:
- Joong Bae Ahn, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient is an adult, ≥ 19 years old at the time of informed consent
- Patient has histologically confirmed advanced adenocarcinoma of colon or rectum
- Patients who were failed in only one treatment with target agent (anti-EGFR Ab or anti-VEGF Ab) combined with FOLFOX
- At least one measurable disease, as defined by RECIST version 1.1
- ECOG PS of 0 to 2.
- Life expectancy ≥ 3 months.
Acceptable hematologic status (without growth factor support or transfusion dependency):
- ANC ≧ 1.5 x 109/L,
- Platelet count ≧100 x 109/L
- Hemoglobin ≧9.0 g/dL.
Acceptable liver function:
- Bilirubin ≤ 1.0 x upper limit of normal(ULN)
- AST, ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN in case of liver metastasis
- Serum creatinine ≤ 1.0 x UNL
- Patients who understand study protocol and signed informed consents.
Exclusion Criteria:
- Previous therapy with other VEGFR inhibitors (other than bevacizumab) or irinotecan
- Patients who have serious underlying co-morbidities which could cause end-organ dysfunction, interfere with the conduct of the study, or that would pose an unacceptable risk to the subject in this study. in the opinion of the Investigator
- Contraindications to the use of FOLFIRI or aflibercept
- Female patients who are pregnant or breast feeding, or male/female patients of reproductive potential who are not willing to employ effective birth control
- Patients who are unable to read the study consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
|
Day 1. Aflibercept + FOLFIRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: up to 5years
|
progressive disease (PD) or death, whichever occurs first. Results will be summarized by arm
|
up to 5years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival (OS)
Time Frame: up to 5years
|
up to 5years
|
ORR (Objective Response Rate)
Time Frame: up to 5years
|
up to 5years
|
Incidence of Adverse events (Safety)/ vital sign(Safety)/ ECOG PS(Safety)
Time Frame: up to 5years
|
up to 5years
|
Prognostic or Predictive Biomarker for Aflibercept (plasma biomarker)
Time Frame: up to 5years
|
up to 5years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joong Bae Ahn, MD, PhD, Severance Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Aflibercept
Other Study ID Numbers
- 4-2019-1285
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
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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