A clinical trial for patients with advanced solid tumors that have the KRAS G12C mutation

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Status

Recruiting

PHASE

Phase 1b

CONDITION

Advanced solid tumors

STUDY DRUGS

sotorasib and other anti-cancer therapies

Contact an Amgen Medical Information Healthcare Professional to learn about ongoing clinical trials.

Why is the CodeBreaK 101 clinical trial being done?

The purpose of the clinical trial is to evaluate the safety and tolerability of a study drug known as sotorasib when used in combination with other anti-cancer therapies. Different study drug combinations will be evaluated in patients with advanced solid tumors that have the KRAS G12C mutation.

Study to evaluate sotorasib with other anti-cancer therapies in advanced solid tumor patients whose cancer has the KRAS G12C mutation

Clinical Trial Reference Number:

NCT04185883

Protocol number: 20190135
If you’re interested in the CodeBreaK 101 clinical trial, you can print this page and show it to your doctor or give this clinical trial reference number to your doctor.

Who can participate?

The study doctor will determine eligibility of each potential participant. If you fit the profile below, this trial might be an option for you.

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Advanced Solid Tumor

Patients diagnosed with 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)

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KRAS G12C Mutation

Patients whose solid tumor contains the KRAS G12C mutation

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Age

Patients who are age 18 years and older

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 find out about the KRAS G12C mutation. You or your doctor can also contact us for more information.

What are the study drugs?

Each study participant will receive a combination of active study drugs-sotorasib plus another anti-cancer therapy-during this clinical trial. The study drug combination you receive is based on your study treatment group. You will know which combination you receive.

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Sotorasib (oral tablets)

  • Once a day

COMBINED WITH

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Anti-cancer therapy

  • Specific treatment varies by study treatment group and may include oral tablets, oral capsules, or IV infusions

What happens in this clinical trial?

If you agree to join the 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 one of two treatment groups. The treatment group you are assigned determines which study drug you receive.

CodeBreaK 101 is a Phase 1b clinical trial.

  • About 500 study participants


Timeline

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 the clinical trial
Timeline

Treatment period

  • The length of time that you receive treatment will vary depending on how you respond to treatment.
  • Attend study appointments
  • Take your assigned study drug
  • Record when you take your dose each day

Long-term follow up period

  • 3+ years
  • Talk to the study team by phone about every 3 months

Where are the 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 this clinical trial, finding a trial location near you, or how to enroll in the trial, contact an Amgen Medical Information Healthcare Professional.

Where can I get more information?

If you want more information about CodeBreaK 101 and whether this clinical trial is an option for you, please contact an Amgen Medical Information Healthcare Professional or talk to your doctor.

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AmgenMedInfo.com

866-572-6436

Monday–Friday 8am to 8pm (ET)

medinfo@amgen.com