Monoclonal Antibodies

Sotorasib for Colorectal Cancer

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

Sotorasib +3 morePhase 3Waitlist AvailableResearch Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow upsapproximately 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Study Summary

This trial is testing two doses of a new drug, sotorasib, to see if it can help people with a certain type of colorectal cancer that has come back after treatment.

Eligible Conditions

Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow ups ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow ups ~ approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS)

Secondary outcome measures

AUC of Panitumumab

Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib

Average Score of Patient Global Impression of Change (PGIC)

+19 more

Awards & 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

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Sotorasib 240 mg QD + panitumumabExperimental Treatment2 Interventions

Group II: Arm A: Sotorasib 960 mg QD + panitumumabExperimental Treatment2 Interventions

Group III: Arm C : Investigator's choiceActive Control2 Interventions

Participants will be administered trifluridine and tipiracil, or regorafenib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sotorasib

2021

Completed Phase 1

~370

Panitumumab

2017

Completed Phase 3

~6580

Do I qualify?Apply below to find out

Find a site

Who is running the clinical trial?

AmgenLead Sponsor

1,326 Previous Clinical Trials

1,341,298 Total Patients Enrolled

MDStudy Director

Amgen

870 Previous Clinical Trials

904,179 Total Patients Enrolled

Media Library

Panitumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05198934 — Phase 3

Colorectal Cancer Research Study Groups: Arm A: Sotorasib 960 mg QD + panitumumab, Arm B: Sotorasib 240 mg QD + panitumumab, Arm C : Investigator's choice

Colorectal Cancer Clinical Trial 2023: Panitumumab Highlights & Side Effects. Trial Name: NCT05198934 — Phase 3

Panitumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05198934 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many facilities are participating in this clinical trial?

"Currently, there are 16 sites where this trial is recruiting patients. To make things more convenient for patients, these sites are located in major cities such as Lansing, Washington and Columbus."

Answered by AI

What are some severe side effects that have been linked to Sotorasib?

"Sotorasib has undergone Phase 3 trials, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety. As such, our team has given it a score of 3 for safety."

Answered by AI

Our research indicates that this study is only meant for individuals who are adults, correct?

"The age requirements to participate in this study are that patients must have celebrated their 18th birthday, and not have their 100th birthday."

Answered by AI

Are there any available vacancies for potential participants in this research?

"Yes, if you visit clinicaltrials.gov you'll see that this trial is still looking for participants. The trial was created on 4/19/2022 and was updated on 10/12/2022. In total, they need 153 participants from 16 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

2022. "Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05198934.