Phase
Condition
N/ATreatment
Panitumumab
Sotorasib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed informed consent.
Age ≥ 18 years.
Life expectancy of > 3 months, in the opinion of the investigator.
Ability to take oral medications and willing to record daily adherence to sotorasibthrough the use of a written diary.
Participant is currently receiving treatment with sotorasib alone or in combinationtherapy in an Amgen-sponsored trial that has met its endpoints or otherwise will bestopping (also referred to as parent study) and are continuing to receive clinicalbenefit in the opinion of the investigator.
For a participant on combination therapy in their parent study, treatment with otheranti-cancer therapies is allowed provided it matches the parent study.
Eastern Cooperative Oncology Group Performance Status of ≤ 2.
Exclusion
Exclusion Criteria:
Participant had permanently discontinued from sotorasib study treatment in theparent study before the parent study's completion.
Ongoing, unresolved toxicity requiring interruption of sotorasib treatment at thetime of the termination of the parent study.
Local access to commercially available investigational product(s) at no cost to theparticipant as permitted by local/country regulation.
Anticipated toxicities of sotorasib study treatment outweigh the clinical benefit tothe participant in the opinion of the investigator.
Participant unlikely to be able to complete all protocol-required procedures,restrictions and requirements, in the judgment of the individual and investigator.
Significant uncontrolled concomitant disease that could affect compliance withprotocol procedures or interpretation of results or that pose a risk to participantsafety, in the opinion of the investigator.
Female participants of childbearing potential unwilling to use protocol-specifiedmethod of contraception during treatment and for an additional:
7 days after the last dose of sotorasib.
2 months after the last dose of panitumumab.
Female participants who are breastfeeding or who plan to breastfeed while on studythrough:
7 days after the last dose of sotorasib.
2 months after the last dose of panitumumab.
Female participants planning to become pregnant while on study through:
7 days after the last dose of sotorasib.
2 months after the last dose of panitumumab.
Female participants of childbearing potential with a positive pregnancy testassessed at screening or day 1 by a highly sensitive urine or serum pregnancy test.
Male participants with a female partner of childbearing potential who are unwillingto practice sexual abstinence (refrain from heterosexual intercourse) or usecontraception during treatment and for an additional 7 days after the last dose ofsotorasib.
Male participants with a pregnant partner who are unwilling to practice abstinenceor use a condom during treatment and for an additional 7 days after the last dose ofsotorasib.
Male participants unwilling to abstain from donating sperm during treatment and foran additional 7 days after the last dose of sotorasib.
Study Design
Connect with a study center
Scientia Clinical Research Ltd
Randwick, New South Wales 2031
AustraliaActive - Recruiting
Centre Leon Berard
Lyon, 69008
FranceActive - Recruiting
Evangelische Lungenklinik
Berlin, 13125
GermanyActive - Recruiting
Henry Dunant Hospital Center
Athens, 11526
GreeceActive - Recruiting
Theagenion Cancer Hospital
Thessaloniki, 54007
GreeceActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
ItalyActive - Recruiting
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido 003-0804
JapanActive - Recruiting
Universitaetsspital Basel
Basel, 4031
SwitzerlandActive - Recruiting
Universitaetsspital Basel
Basel 2661604, 4031
SwitzerlandSite Not Available
Taichung Veterans General Hospital
Taichung, 40705
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung 1668399, 40705
TaiwanSite Not Available
Florida Cancer Specialists - Fort Myers
Fort Myers, Florida 33901
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.