Clinical trial NCT04185883: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Official title: A Phase 1b, 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Men or women greater than or equal to 18 years old.
* Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Exclusion Criteria:

* Primary brain tumor.
* Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
* Myocardial infarction within 6 months of study day 1.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: 12 Months
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: 12 Months
measure: Number of Participants with Treatment-related Adverse Events
timeFrame: 12 Months
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: 12 Months
measure: Number of Participants with Clinically Significant Changes in ECG Measurements
timeFrame: 12 Months
measure: Number of Participants with Clinically Significant Changes in Laboratory Test Values
timeFrame: 12 Months
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 12 Months
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: 12 Months
measure: Area Under the Plasma Concentration-time Curve (AUC)
timeFrame: 12 Months
measure: Objective Response Rate
timeFrame: 12 Months
measure: Disease Control Rate
timeFrame: 12 Months
measure: Duration of Response
timeFrame: 12 Months
measure: Progression-free Survival
timeFrame: 12 Months
measure: Duration of Stable Disease
timeFrame: 12 Months
measure: Time to Response
timeFrame: 12 Months
measure: Overall Survival
timeFrame: 12 Months
measure: Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels
timeFrame: 12 Months
measure: Sotorasib Monotherapy Only: Intracranial Objective Response Rate
timeFrame: 12 Months
measure: Sotorasib Monotherapy Only: Intracranial Disease Control Rate
timeFrame: 12 Months
measure: Sotorasib Monotherapy Only: Intracranial Duration of Response
timeFrame: 12 Months
measure: Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy
timeFrame: 12 Months
measure: Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS)
timeFrame: 12 Months
measure: Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS)
timeFrame: 12 Months
measure: Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS)
timeFrame: 12 Months
measure: Sotorasib + TNO155 Only: Best Overall Response
timeFrame: 12 Months
measure: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: 12 Months
measure: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: 12 Months
measure: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events
timeFrame: 12 Months
measure: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: 12 Months
measure: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements
timeFrame: 12 Months
measure: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values
timeFrame: 12 Months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates Professional Corporation
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California, Norris Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Mission Bay Campus
state: California
city: Santa Monica
country: United States
facility: University of California Los Angeles
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers Denver Midtown
state: Colorado
city: Denver
country: United States
facility: Sarah Cannon Research Institute
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Gibbs Cancer Center and Research Institute - Spartanburg
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Nashville
country: United States
facility: United States Oncology Regulatory Affairs Corporate Office
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology Central-South
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: US Oncology Research Investigational Products Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology Northeast Texas
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists - Vancouver
state: Washington
city: Kingswood
country: Australia
facility: Nepean Cancer Centre
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare -North Shore Oncology
state: New South Wales
city: South Brisbane
country: Australia
facility: Icon Cancer Care South Brisbane
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Subiaco
country: Australia
facility: St John of God Healthcare
state: Western Australia
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Bruxelles
country: Belgium
facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Quebec
country: Canada
facility: CHU de Quebec Hopital de l Enfant Jesus
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin, Campus Virchow
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Koeln
country: Germany
facility: Universitatsklinikum Koln
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
state: Cataluña
city: Hospitalet de Llobregat
country: Spain
facility: Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
state: Cataluña
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Kuboki Y, Fakih M, Strickler J, Yaeger R, Masuishi T, Kim EJ, Bestvina CM, Kopetz S, Falchook GS, Langer C, Krauss J, Puri S, Cardona P, Chan E, Varrieur T, Mukundan L, Anderson A, Tran Q, Hong DS. Sotorasib with panitumumab in chemotherapy-refractory KRASG12C-mutated colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):265-270. doi: 10.1038/s41591-023-02717-6. Epub 2024 Jan 4.