Monoclonal Antibodies

Sotorasib for Colorectal Cancer

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
Sotorasib +3 morePhase 3Waitlist AvailableResearch Sponsored by Amgen

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


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
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1
Completed Phase 3

Find a site

Who is running the clinical trial?

AmgenLead Sponsor
1,326 Previous Clinical Trials
1,341,298 Total Patients Enrolled
MDStudy Director
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 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
~80 spots leftby Mar 2025