Actively Recruiting
A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
Led by Amgen · Updated on 2026-05-14
14
Participants Needed
11
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of the study is to evaluate the safety and tolerability of the continuation of sotorasib with or without panitumumab and/or other anti-cancer therapies in participants continuing to derive benefit in Amgen-sponsored protocols.
CONDITIONS
Official Title
A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Age 18 years or older.
- Life expectancy greater than 3 months as judged by the investigator.
- Ability to take oral medications and willingness to record daily sotorasib adherence with a written diary.
- Currently receiving sotorasib alone or in combination in an Amgen-sponsored trial that has met endpoints or will stop, with ongoing clinical benefit.
- For combination therapy participants, other anti-cancer treatments allowed if matching the parent study.
- Eastern Cooperative Oncology Group Performance Status of 2 or less.
You will not qualify if you...
- Permanently stopped sotorasib treatment in the parent study before its completion.
- Ongoing unresolved toxicity requiring sotorasib interruption at parent study end.
- Local access to investigational products at no cost, if allowed by regulation.
- Investigator judges sotorasib toxicities outweigh clinical benefit.
- Unable to complete protocol procedures or follow restrictions.
- Significant uncontrolled diseases affecting compliance or safety.
- Female of childbearing potential unwilling to use contraception during treatment and for 7 days after sotorasib or 2 months after panitumumab.
- Female breastfeeding or planning to breastfeed during and after treatment as above.
- Female planning pregnancy during and after treatment as above.
- Female of childbearing potential with positive pregnancy test at screening or day 1.
- Male with female partner of childbearing potential unwilling to practice abstinence or use contraception during and 7 days after sotorasib.
- Male with pregnant partner unwilling to abstain or use condoms during and 7 days after sotorasib.
- Male unwilling to abstain from sperm donation during and 7 days after sotorasib.
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Florida Cancer Specialists - Fort Myers
Fort Myers, Florida, United States, 33901
Actively Recruiting
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031
Actively Recruiting
4
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
5
Evangelische Lungenklinik
Berlin, Germany, 13125
Actively Recruiting
6
Henry Dunant Hospital Center
Athens, Greece, 11526
Actively Recruiting
7
Theagenion Cancer Hospital
Thessaloniki, Greece, 54007
Actively Recruiting
8
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
9
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Actively Recruiting
10
Universitaetsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
11
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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