Contact an Amgen Medical Information Healthcare Professional to learn about ongoing clinical trials.
Why are CodeBreaK 100 and 101 clinical trials being done?
The purpose of the CodeBreaK 100 and 101 clinical trials is to evaluate the effectiveness, safety, and tolerability of a study drug known as sotorasib. The CodeBreaK 100 and 101 clinical trials are evaluating sotorasib when it is given alone and when it is given in combination with approved anti-cancer therapies.
CodeBreaK 100
NCT03600883
CodeBreaK 101
NCT04185883
If you’re interested in the CodeBreaK clinical trial, you can print this page and show it to your doctor or give the above clinical trial reference numbers to your doctor.
Who can participate?
A study doctor will determine eligibility of each potential participant. If you fit the profile below, a CodeBreaK clinical trial might be an option for you.
Advanced Solid Tumors
Patients diagnosed with a solid tumor that has spread to areas near the part of the body where it started (locally advanced) or to other parts of the body (metastatic)
KRAS G12C Mutation
Patients whose solid tumor has the KRAS G12C mutation
Age
Patients who are age 18 years and older
Study participants must also meet additional eligibility criteria. For information about these criteria, please contact an Amgen Medical Information Healthcare Professional
How do I know if my cancer has the KRAS G12C mutation?
You may have already been tested for genetic mutations related to cancer. You can ask your doctor about this testing, which is called biomarker testing, to determine if your cancer has the KRAS G12C mutation. You or your doctor can also contact us for more information.
What are the study drugs?
All CodeBreaK clinical trial participants receive either sotorasib alone or sotorasib in combination with other anti-cancer therapies. Whether you receive sotorasib alone or in combination with other anti-cancer therapies depends on which CodeBreaK study you are in and the study group to which you are assigned.
Sotorasib (oral tablets)
- Once a day
- Alone or in combination with an anti-cancer therapy
Anti-cancer therapy
- Specific treatment varies by study treatment group and may include oral tablets, oral capsules, or IV infusions.
- Approved drug*
What happens in the CodeBreaK 100 and 101 clinical trials?
If you agree to join a CodeBreaK clinical trial, you will go to the study clinic for assessments of your cancer and your overall health to find out if you meet all requirements for participation.
If you meet all requirements for participation and decide to continue, you will be assigned to a study group. The study group to which you are assigned will determine whether you receive sotorasib alone or sotorasib in combination with other anti-cancer therapies.
CodeBreaK 100 is a Phase 1/2
study.
CodeBreaK 101 is a Phase 1b/2
study.
Screening period (up to 4 weeks)
- Attend a screening visit to provide medical history
- Have medical testing done to see if you meet the requirements for participating in a CodeBreaK clinical trial
Study treatment period**
- Receive sotorasib alone or sotorasib in combination with other anti-cancer therapies.
- Attend study appointments and get imaging to monitor how your disease is responding to treatment
**The length of time that you receive treatment will vary depending on how you respond to treatment.
Long-term follow up period (approximately 3 to 5 years)
- Talk to the study team by phone or visit the study clinic about every 3 months
Where are the CodeBreaK clinical trial locations?
Initially, this map displays the clinical trial locations near the “internet address” of the computer you are using to view this website. Amgen will not attempt to find your location using this information. Read our privacy statement for more information about data privacy and your rights.
You can use the search field to find different locations. Additional locations may be added on an ongoing basis.
If you want more information about a CodeBreaK clinical trial, finding a trial location near you, or how to enroll in a trial, contact an Amgen Medical Information Healthcare Professional.
-
{{i.distance}}
miles
Where can I get more information?
If you want more information about CodeBreaK clinical trials and whether you may be eligible for one of these clinical trials, please contact an Amgen Medical Information Healthcare Professional or talk to your doctor.
