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Trial Summary

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors

Acronym:

CodeBreak 101

ACTRN/NCT /ethics:

NCT04185883

Scientific title:

A Phase 1b/2, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Sponsor / Cooperative group:

Amgen

Trial & Patient Characteristics

Cancer TypeAll cancers
Trial TypeTreatment
PhasePhase I, Phase II
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageLocally Advanced
Anticipated Start Date2019-12-17
Anticipated End Date2024-01-12

Participating Hospitals

HospitalThe Queen Elizabeth Hospital
Clinical Trial CoordinatorPamela Cooper
Emailpamela.cooper@sa.gov.au
Phone08 8222 6140
Principal InvestigatorDr Timothy Price
Recruitment StatusRecruiting