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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years 9 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests a new combination of drugs for patients with a specific type of colorectal cancer who haven't responded to other treatments. The combination includes antibodies that help the immune system attack cancer cells and a chemotherapy drug that stops them from growing.
Eligible Conditions
- Metastatic Colorectal Cancer
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Adverse Events (Phase III Part)
Overall Survival (In Triple Negative) (Phase III Part)
Overall Survival (Safety Lead-In Part)
+1 moreAwards & Highlights
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.
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
~760
Find a Location
Who is running the clinical trial?
ADIR, a Servier Group companyIndustry Sponsor
32 Previous Clinical Trials
4,327 Total Patients Enrolled
Institut de Recherches Internationales ServierLead Sponsor
90 Previous Clinical Trials
67,147 Total Patients Enrolled
Fortunato CiardielloPrincipal InvestigatorUniversity of Campania "Luigi Vanvitelli"
3 Previous Clinical Trials
460 Total Patients Enrolled
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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.
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