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Monoclonal Antibodies
Sotorasib + Panitumumab for Colorectal Cancer (CodeBreak300 Trial)
Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically documented metastatic colorectal adenocarcinoma with Kirsten rat sarcoma (KRAS) p.G12C mutation as determined by prospective central testing, using the analytically validated Qiagen Therascreen KRAS RGQ polymerase chain reaction Kit in CRC as an investigational device demonstrating a KRAS p.G12C mutation is present. Local testing and documentation of KRAS p.G12C mutation should have been previously performed as part of standard of care.
- Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥30 mL/min/1.73 m^2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights
CodeBreak300 Trial 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.
Who is the study for?
Adults over 18 with metastatic colorectal cancer that has a specific mutation (KRAS p.G12C) can join this trial. They must have tried at least one other treatment and their cancer should be measurable by certain medical criteria. Good organ function and performance status are required, but those with severe skin, breast, or prostate conditions without current disease, brain metastases treated over 4 weeks ago without progression, or other cancers cured more than 3 years ago may also qualify.Check my eligibility
What is being tested?
The study is testing the effectiveness of Sotorasib combined with Panitumumab against either Trifluridine/Tipiracil or Regorafenib in patients whose colorectal cancer has progressed after previous treatments. The main goal is to see which combination helps slow down the cancer's growth better.See study design
What are the potential side effects?
Potential side effects include skin reactions from Panitumumab; liver enzyme changes from Sotorasib; fatigue and hand-foot syndrome from Regorafenib; and low blood counts leading to infections, fatigue, nausea from Trifluridine/Tipiracil.
CodeBreak300 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My colorectal cancer has a specific KRAS mutation.
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My kidney function, based on a specific test, is at an acceptable level.
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My blood counts and organ functions are within the required ranges for the trial.
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.
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My colorectal cancer has a specific KRAS mutation.
CodeBreak300 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
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 moreCodeBreak300 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
2020
Completed Phase 3
~6490
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,528 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,971 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bladder cancer has been treated and is not invasive.I had skin cancer (not melanoma) treated and currently show no signs of it.My cancer was treated over 3 years ago, with no current signs of it and considered low risk for coming back.My breast ductal carcinoma in situ has been treated and shows no signs of disease.I had brain metastases treated and stable for over 4 weeks with no new growth.I do not have serious heart conditions like recent heart attacks or unstable heart rhythms.My cancer can be measured by scans and has grown after any radiation treatments.My colorectal cancer has a specific KRAS mutation.My kidney function, based on a specific test, is at an acceptable level.My blood and organ functions are within normal ranges as of two weeks ago.I've had at least one treatment for my cancer after it spread and it didn't work or my cancer came back.I had cervical cancer that was treated and now shows no signs of the disease.My blood counts and organ functions are within the required ranges for the trial.I have or had lung scarring or inflammation.I have had cancer other than my current one in the last 3 years.I have a prostate condition but no prostate cancer.I am able to care for myself and perform daily activities.I am 18 years old or older.I have a severe stomach or intestine problem that affects my nutrition.I have been treated with a KRAS G12C inhibitor before.My cancer has spread to the lining of my brain and spinal cord.My colorectal cancer has a specific KRAS mutation.I had blood cancer but have been free of it for over 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Sotorasib 960 mg QD + panitumumab
- Group 2: Arm B: Sotorasib 240 mg QD + panitumumab
- Group 3: Arm C : Investigator's choice
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 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
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