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Monoclonal Antibodies
Futuximab/modotuximab for Colorectal Cancer (COLSTAR Trial)
Phase 3
Waitlist Available
Led By Fortunato Ciardiello
Research Sponsored by Institut de Recherches Internationales Servier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with measurable or non-measurable lesion
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years 9 months
Awards & highlights
COLSTAR Trial Summary
This trial is testing a new combo drug for people with metastatic colorectal cancer who have already tried other treatments. The first part is to see if it's safe, and the second part is to see if it's better than the current best treatment.
Eligible Conditions
- Metastatic Colorectal Cancer
COLSTAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have visible signs of a medical condition that can be measured or not measured by medical tests.
COLSTAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Dose-limiting Toxicities (DLTs) (Safety Lead-In Part)
Overall Survival (OS) (In Double Negative, KRAS/NRAS and BRAF Wild Type Patients) (Phase III Part)
Secondary outcome measures
Adverse Events (Phase III Part)
Overall Survival (In Triple Negative) (Phase III Part)
Overall Survival (Safety Lead-In Part)
+1 moreCOLSTAR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Futuximab/modotuximab combined with trifluridine/tipiracil (Safety Lead-In and Phase III parts)Experimental Treatment2 Interventions
Group II: Trifluridine/tipiracil (Phase III part)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trifluridine/Tipiracil
2019
Completed Phase 3
~790
Find a Location
Who is running the clinical trial?
ADIR, a Servier Group companyIndustry Sponsor
32 Previous Clinical Trials
4,389 Total Patients Enrolled
Institut de Recherches Internationales ServierLead Sponsor
86 Previous Clinical Trials
69,554 Total Patients Enrolled
Fortunato CiardielloPrincipal InvestigatorUniversity of Campania "Luigi Vanvitelli"
3 Previous Clinical Trials
460 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have visible signs of a medical condition that can be measured or not measured by medical tests.You have been diagnosed with another type of cancer.You currently have a severe, active, or uncontrolled infection.You have a serious problem with your stomach or intestines.You have a severe skin rash or other skin problems that prevent you from participating in the study, as determined by the doctor in charge.
Research Study Groups:
This trial has the following groups:- Group 1: Trifluridine/tipiracil (Phase III part)
- Group 2: Futuximab/modotuximab combined with trifluridine/tipiracil (Safety Lead-In and Phase III parts)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are receiving therapy through this clinical trial?
"That is correct. The clinicaltrials.gov website lists this trial as active and presently looking for 500 patients from 2 locations. The first posting was on 4/21/2022 with the most recent update being on 7/5/2022."
Answered by AI
Is Futuximab/modotuximab a safe medication for people?
"Futuximab/modotuximab is a Phase 3 trial drug, so it has some evidence of efficacy and multiple rounds of data supporting safety. We rated its safety as a 3."
Answered by AI
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