RecruitingPHASE2INTERVENTIONAL

A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation

This study is for people with advanced solid cancers who have a specific genetic change called KRAS p.G12C. These patients are already benefiting from treatment with sotorasib in another study. This new study, called a 'rollover study,' aims to let them continue receiving sotorasib, either on its own or sometimes साथ with another drug called panitumumab. The main goal is to carefully check how safe these treatments are and how well patients tolerate them over a longer period. It's designed to ensure that those who are already finding benefit from their current treatment can keep access to it as their initial study concludes.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Amgen

Enrolment target

Start

02 Jan 2026

Estimated completion

02 Jan 2028

Advanced Solid Tumors

What is this study about?

This study is for people who have advanced cancer that has a specific genetic change, known as a KRAS p.G12C mutation. You might be considering this study if you're already taking part in another Amgen study where you've been receiving sotorasib (either alone or with other cancer treatments) and your doctors feel you are still benefiting from it. As your current study is ending, this new study provides a way for you to potentially continue receiving sotorasib.

In this study, some people might continue with sotorasib only, while others might receive sotorasib along with another treatment called panitumumab, or even other anti-cancer therapies if that's what they were already on. The main purpose of this research is to keep a close eye on the safety of these treatments and see how well people cope with them over time. It's really about ensuring that those who are already benefiting from sotorasib can continue to access it responsibly.

It's important to understand that this isn’t a new trial testing if sotorasib works; rather, it’s a way for people already doing well on sotorasib to continue their treatment. The researchers want to gather more information on the long-term safety and tolerability when treatment is continued. This kind of study is helpful for gathering more comprehensive data on these treatments.

Key takeaways

This study continues treatment for people already benefiting from sotorasib.
It's for advanced solid cancers with a specific KRAS p.G12C genetic change.
You might receive sotorasib alone or with panitumumab.
The main goal is to check treatment safety and how well it's tolerated over time.
Participation involves ongoing monitoring and taking medication as prescribed.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 18 years old and already be receiving sotorasib treatment in another Amgen study. Your doctor must believe that you are currently benefiting from this treatment and that you have a life expectancy of more than three months. You also need to be able to take medicines by mouth and keep a daily record of when you take your sotorasib.

There are also some reasons why you might not be able to join. For example, if you stopped sotorasib treatment permanently in your previous study before it finished, or if you have side effects that haven't cleared up and need your sotorasib treatment to be paused. Your doctor will also consider if continuing the treatment is truly beneficial for you and if you have any other serious health conditions that could make taking part unsafe or difficult.

Women who could become pregnant must agree to use specific birth control methods during the study and for a period after their last dose of sotorasib or panitumumab. Women who are breastfeeding cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently receiving sotorasib in another Amgen study and benefiting from it?
Can you take medicines by mouth and keep a daily diary?
Do you have a life expectancy of more than 3 months (as judged by your doctor)?
Are you able to attend regular appointments for monitoring?
If female and able to become pregnant, are you willing to use specific birth control methods?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to take sotorasib by mouth, likely every day, and you'll need to keep a diary to record when you take it. Depending on your situation, you might also receive panitumumab or other anti-cancer treatments you were already on in your previous study. The study doesn't specify the exact number of visits, but you can expect regular check-ups with your study doctor and nurses.

During these visits, healthcare professionals will monitor your health closely, asking about any side effects you might be experiencing. They will also perform physical examinations and likely take blood tests or other assessments to check how your body is responding to the treatment and to monitor for any potential issues. The duration of your participation will depend on how you respond to the treatment and until the study concludes, or if you and your doctor decide to stop treatment. You will also have follow-up appointments and assessments after you stop the study medicine.

Potential risks and benefits

The potential benefit of joining this study is that you can continue to receive sotorasib, and possibly panitumumab, if your doctor believes it is currently helping your cancer. This allows you to maintain access to a treatment that is working for you as your previous study ends. However, like all medications, sotorasib and panitumumab can have side effects, which vary from person to person. These risks will be fully explained by your study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (11)

Florida Cancer Specialists - Fort Myers
Verified postcode
Fort Myers, United States· Recruiting
University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Scientia Clinical Research Ltd
Verified postcode
Randwick, Australia· Recruiting
Centre Leon Berard
Verified postcode
Lyon, France· Recruiting
Evangelische Lungenklinik
Verified postcode
Berlin, Germany· Recruiting
Henry Dunant Hospital Center
Verified postcode
Athens, Greece· Recruiting
Theagenion Cancer Hospital
Verified postcode
Thessaloniki, Greece· Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verified postcode
Roma, Italy· Recruiting
National Hospital Organization Hokkaido Cancer Center
Verified postcode
Sapporo, Japan· Recruiting
Universitaetsspital Basel
Verified postcode
Basel, Switzerland· Recruiting
Taichung Veterans General Hospital
Verified postcode
Taichung, Taiwan· Recruiting

Common questions

What is the main purpose of this study?

The main purpose is to let people who are currently benefiting from sotorasib continue their treatment and to monitor its long-term safety and tolerability.

Who is eligible to join this study?

It's for adults (18+) with advanced solid cancers who have a specific genetic change (KRAS p.G12C) and are already doing well on sotorasib in another Amgen study.

Will I receive new drugs in this study?

You'll continue sotorasib, and you might also receive panitumumab if that's what your doctor decides, or other treatments if you were already on them.

What does 'rollover study' mean?

It means you're moving from one study to another to continue getting a treatment that is benefiting you, because the first study is ending.

What are the potential side effects?

Like all medicines, sotorasib and panitumumab can have side effects. Your study doctor will explain all known and potential side effects to you.

How to find out more

Amgen Call Center

medinfo@amgen.com 866-572-6436 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.