Clinical trial NCT03785249: Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Official title: A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Metastatic Cancer
Malignant Neoplastic Disease
Keywords: KRAS
NSCLC
Colorectal Cancer
Colon Cancer
Metastatic Cancer
Pancreatic Cancer
Adagrasib
STK11 mutation
KRAS G12C
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-24
Enrollment: 822
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.

Detailed description: This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
* Unresectable or metastatic disease
* Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
* Adequate organ function

Exclusion Criteria:

* History of intestinal disease or major gastric surgery or inability to swallow oral medications
* Other active cancer

Primary outcomes:
measure: Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation
timeFrame: 20 months
measure: Evaluate the pharmacokinetics of MRTX849
timeFrame: 20 months
measure: Evaluate clinical activity/efficacy of MRTX849
timeFrame: 20 months
Secondary outcomes:
measure: Establish maximum tolerated dose
timeFrame: 12 months
measure: Characterize safety and tolerability of MRTX849 in combination with selected therapeutic agents
timeFrame: 12 months
measure: Evaluate the pharmacokinetics of new MRTX849 oral formulations
timeFrame: 6 months
measure: Evaluate the pharmacokinetics of MRTX849 administered with food
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: ONeal Comprehensive Cancer Center at the University of Alabama at Birmingham
state: Alabama
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology
state: Alaska
city: Phoenix
country: United States
facility: Mayo Clinic Arizona - Phoenix Campus
state: Arizona
city: Scottsdale
country: United States
facility: Local Institution - 001-807
state: Arizona
city: Tucson
country: United States
facility: Local Institution - 001-873-A
state: Arizona
city: Tucson
country: United States
facility: USOR - Arizona Oncology - Tucson - Rudasill
state: Arizona
city: Bellflower
country: United States
facility: Local Institution - 001-840-B
state: California
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Duarte
country: United States
facility: City of Hope - Duarte (Main Campus)
state: California
city: Dublin
country: United States
facility: Local Institution - 001-850-K
state: California
city: Fullerton
country: United States
facility: Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton
state: California
city: Harbor City
country: United States
facility: Local Institution - 001-840-C
state: California
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: Los Alamitos
country: United States
facility: TRIO - Cancer and Blood Specialty Clinic
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group - Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian - Newport Beach
state: California
city: Oakland
country: United States
facility: Local Institution - 001-850-B
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Roseville
country: United States
facility: Local Institution - 001-850-C
state: California
city: Sacramento
country: United States
facility: Local Institution - 001-850-J
state: California
city: Sacramento
country: United States
facility: Local Institution - 001-850-D
state: California
city: San Diego
country: United States
facility: California Cancer Associates for Research and Excellence (cCARE) - San Diego 4S Ranch
state: California
city: San Diego
country: United States
facility: Local Institution - 001-840-A
state: California
city: San Francisco
country: United States
facility: Local Institution - 001-850-H
state: California
city: San Francisco
country: United States
facility: Local Institution - 001-850-E
state: California
city: San Jose
country: United States
facility: Local Institution - 001-850-F
state: California
city: San Leandro
country: United States
facility: Local Institution - 001-850-A
state: California
city: Santa Barbara
country: United States
facility: Ridley - Tree Cancer Center - Santa Barbara
state: California
city: Santa Clara
country: United States
facility: Local Institution - 001-850-I
state: California
city: Solvang
country: United States
facility: Local Institution - 001-884-A
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Vallejo Medical Center
state: California
city: Walnut Creek
country: United States
facility: Local Institution - 001-850-G
state: California
city: Aurora
country: United States
facility: USOR - Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Aurora
country: United States
facility: UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
state: Colorado
city: Boulder
country: United States
facility: Local Institution - 001-872-H
state: Colorado
city: Colorado Springs
country: United States
facility: Local Institution - 001-872-E
state: Colorado
city: Colorado Springs
country: United States
facility: Local Institution - 001-872-L
state: Colorado
city: Denver
country: United States
facility: Local Institution - 001-872-B
state: Colorado
city: Denver
country: United States
facility: Local Institution - 001-951 - A
state: Colorado
city: Denver
country: United States
facility: Local Institution - 001-951 - B
state: Colorado
city: Grand Junction
country: United States
facility: Cancer Centers of Colorado - St. Marys Regional Hospital
state: Colorado
city: Lafayette
country: United States
facility: SCL Health - Saint Joseph Hospital Cancer Center
state: Colorado
city: Lakewood
country: United States
facility: Local Institution - 001-872-A
state: Colorado
city: Littleton
country: United States
facility: Local Institution - 001-872-D
state: Colorado
city: Lone Tree
country: United States
facility: Local Institution - 001-872-K
state: Colorado
city: Longmont
country: United States
facility: Local Institution - 001-872-C
state: Colorado
city: Parker
country: United States
facility: Local Institution - 001-872-J
state: Colorado
city: Pueblo
country: United States
facility: Local Institution - 001-872-F
state: Colorado
city: Pueblo
country: United States
facility: Local Institution - 001-872-G
state: Colorado
city: Thornton
country: United States
facility: Local Institution - 001-872-I
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Newark
country: United States
facility: USOR - Medical Oncology Hematology Consultants
state: Delaware
city: Altamonte Springs
country: United States
facility: Local Institution - 001-929i
state: Florida
city: Boca Raton
country: United States
facility: Boca Raton Clinical Research Associates, Inc.
state: Florida
city: Bonita Springs
country: United States
facility: Local Institution - 001-922A
state: Florida
city: Bradenton
country: United States
facility: Local Institution - 001-922D
state: Florida
city: Brandon
country: United States
facility: Local Institution - 001-929c
state: Florida
city: Cape Coral
country: United States
facility: Local Institution - 001-922E
state: Florida
city: Clearwater
country: United States
facility: Local Institution - 001-929g
state: Florida
city: Daytona Beach
country: United States
facility: Local Institution - 001-926b
state: Florida
city: Fort Myers
country: United States
facility: SCRI - Florida Cancer Specialists - South Region Research Office
state: Florida
city: Fort Myers
country: United States
facility: Local Institution - 001-922B
state: Florida
city: Fort Myers
country: United States
facility: Local Institution - 001-922C
state: Florida
city: Gainesville
country: United States
facility: Local Institution - 001-929b
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Lady Lake
country: United States
facility: Local Institution - 001-929m
state: Florida
city: Largo
country: United States
facility: Local Institution - 001-929e
state: Florida
city: Lecanto
country: United States
facility: Local Institution - 001-929n
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Naples
country: United States
facility: Local Institution - 001-922F
state: Florida
city: Naples
country: United States
facility: Local Institution - 001-922G
state: Florida
city: Ocala
country: United States
facility: Florida Cancer Affiliates - Ocala - Main
state: Florida
city: Ocala
country: United States
facility: Local Institution - 001-929p
state: Florida
city: Orange City
country: United States
facility: Local Institution - 001-929j
state: Florida
city: Orange City
country: United States
facility: Mid Florida Cancer Centers - Orange City
state: Florida
city: Orlando
country: United States
facility: Local Institution - 001-929l
state: Florida
city: Pensacola
country: United States
facility: Woodlands Medical Specialists
state: Florida
city: Port Charlotte
country: United States
facility: Local Institution - 001-922H
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution - 001-929a
state: Florida
city: Saint Petersburg
country: United States
facility: SCRI - Florida Cancer Specialists - North Region Research Office
state: Florida
city: Sarasota
country: United States
facility: Local Institution - 001-922I
state: Florida
city: Sarasota
country: United States
facility: Local Institution - 001-922J
state: Florida
city: Spring Hill
country: United States
facility: Local Institution - 001-929h
state: Florida
city: Stuart
country: United States
facility: Local Institution - 001-926d
state: Florida
city: Tampa
country: United States
facility: Local Institution - 001-929d
state: Florida
city: Tavares
country: United States
facility: Local Institution - 001-929k
state: Florida
city: Trinity
country: United States
facility: Local Institution - 001-929f
state: Florida
city: Venice
country: United States
facility: Local Institution - 001-922K
state: Florida
city: Venice
country: United States
facility: Local Institution - 001-922L
state: Florida
city: Vero Beach
country: United States
facility: Local Institution - 001-926c
state: Florida
city: Wellington
country: United States
facility: Local Institution - 001-926a
state: Florida
city: West Palm Beach
country: United States
facility: SCRI - Florida Cancer Specialists - East Region Research Office
state: Florida
city: Winter Park
country: United States
facility: Local Institution - 001-929o
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center (UCBC) - Athens
state: Georgia
city: Austell
country: United States
facility: Local Institution - 001-835-C
state: Georgia
city: Austell
country: United States
facility: Local Institution - 001-835-E
state: Georgia
city: Carrollton
country: United States
facility: Local Institution - 001-835-D
state: Georgia
city: Carrollton
country: United States
facility: Local Institution - 001-835-F
state: Georgia
city: Cartersville
country: United States
facility: Local Institution - 001-835-A
state: Georgia
city: Douglasville
country: United States
facility: Local Institution - 001-835-B
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers Wellstar - Marietta
state: Georgia
city: Chicago Ridge
country: United States
facility: Affiliated Oncologists, LLC
state: Illinois
city: Chicago
country: United States
facility: Local Institution - 001-828
state: Illinois
city: Niles
country: United States
facility: USOR - Illinois Cancer Specialists - Niles
state: Illinois
city: South Bend
country: United States
facility: Memorial Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Westwood
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baton Rouge
country: United States
facility: SCRI - Hematology Oncology Clinic - Baton Rouge
state: Louisiana
city: Biddeford
country: United States
facility: MaineHealth Cancer Care - Biddeford
state: Maine
city: Brandywine
country: United States
facility: Local Institution - 001-881-B
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology - Columbia
state: Maryland
city: Silver Spring
country: United States
facility: Local Institution - 001-881-A
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Farmington Hills
country: United States
facility: Local Institution - 001-842-A
state: Michigan
city: Coon Rapids
country: United States
facility: Local Institution - 001-838-F
state: Minnesota
city: Edina
country: United States
facility: Local Institution - 001-838-E
state: Minnesota
city: Edina
country: United States
facility: Local Institution - 001-875 - D
state: Minnesota
city: Maplewood
country: United States
facility: Local Institution - 001-838-D
state: Minnesota
city: Maplewood
country: United States
facility: Local Institution - 001-875 - A
state: Minnesota
city: Minneapolis
country: United States
facility: Local Institution - 001-838-C
state: Minnesota
city: Minneapolis
country: United States
facility: USOR - Minnesota Oncology - Minneapolis Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: Local Institution - 001-838-G
state: Minnesota
city: Minneapolis
country: United States
facility: Local Institution - 001-822-A
state: Minnesota
city: Minneapolis
country: United States
facility: Masonic Cancer Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro-Minnesota Community Oncology Research Consortium (MMCORC)
state: Minnesota
city: Saint Louis Park
country: United States
facility: Local Institution - 001-838-B
state: Minnesota
city: Saint Paul
country: United States
facility: Local Institution - 001-838-A
state: Minnesota
city: Saint Paul
country: United States
facility: Local Institution - 001-875 - B
state: Minnesota
city: Woodbury
country: United States
facility: Local Institution - 001-875 - C
state: Minnesota
city: Bolivar
country: United States
facility: Central Care Cancer Center - Bolivar
state: Missouri
city: Jefferson City
country: United States
facility: Goldschmidt Cancer Center
state: Missouri
city: Billings
country: United States
facility: Sisters of Charity of Leavenworth Health St. Marys
state: Montana
city: Omaha
country: United States
facility: Local Institution - 001-544B
state: Nebraska
city: Omaha
country: United States
facility: Methodist Estabrook Cancer Center
state: Nebraska
city: Omaha
country: United States
facility: Local Institution - 001-544A
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Henderson
country: United States
facility: Local Institution - 001-860A
state: Nevada
city: Henderson
country: United States
facility: Local Institution - 001-860C
state: Nevada
city: Henderson
country: United States
facility: Local Institution - 001-860B
state: Nevada
city: Henderson
country: United States
facility: USOR - Comprehensive Cancer Centers of Nevada - Southeast Henderson
state: Nevada
city: Las Vegas
country: United States
facility: Local Institution - 001-860E
state: Nevada
city: Las Vegas
country: United States
facility: Local Institution - 001-860D
state: Nevada
city: Las Vegas
country: United States
facility: Local Institution - 001-860F
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology - Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: Lake Success
country: United States
facility: Local Institution - 001-832
state: New York
city: New York
country: United States
facility: Perlmutter Cancer Center - 34th Street
state: New York
city: New York
country: United States
facility: Local Institution - 001-583
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - New York
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Health Barrett Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Lerner College of Medicine
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 001-833 - H
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 001-833 - C
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 001-833 - J
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 001-833 - A
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 001-833 - F
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University College of Medicine
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 001-833 - D
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 001-833 - I
state: Ohio
city: Columbus
country: United States
facility: SCRI - Mark H. Zangmeister Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 001-833 - B
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 001-833 - G
state: Ohio
city: Gahanna
country: United States
facility: Local Institution - 001-833 - E
state: Ohio
city: Kettering
country: United States
facility: Kettering Health Cancer Center - Main Campus
state: Ohio
city: Kettering
country: United States
facility: Local Institution - 001-836-A
state: Ohio
city: Lawton
country: United States
facility: Cancer Centers of Southwest Oklahoma - Leah M. Fitch Cancer Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Local Institution - 001-580
state: Oklahoma
city: Tulsa
country: United States
facility: Local Institution - 001-584
state: Oklahoma
city: Bend
country: United States
facility: Local Institution - 001-586-A
state: Oregon
city: Bend
country: United States
facility: St. Charles Health System
state: Oregon
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center - Eugene
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Physician Group Hematology Oncology
state: Pennsylvania
city: Bethlehem
country: United States
facility: Local Institution - 001-837-A
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
city: Media
country: United States
facility: USOR - Alliance Cancer Specialists - Media (Cancer Center at Riddle Memorial Hospital)
state: Pennsylvania
city: Charleston
country: United States
facility: USOR - Charleston Hematology Oncology Associates
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Gallatin
country: United States
facility: Local Institution - 001-801-G
state: Tennessee
city: Hendersonville
country: United States
facility: Local Institution - 001-801-A
state: Tennessee
city: Hermitage
country: United States
facility: Local Institution - 001-801-D
state: Tennessee
city: Murfreesboro
country: United States
facility: Local Institution - 001-801-F
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 001-801-B
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 001-801-E
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 001-801-C
state: Tennessee
city: Arlington
country: United States
facility: Local Institution - 001-888-B
state: Texas
city: Arlington
country: United States
facility: USOR - Texas Oncology Dallas Fort Worth West (DFWW) - Arlington South
state: Texas
city: Austin
country: United States
facility: USOR - Texas Oncology - Austin Central
state: Texas
city: Conroe
country: United States
facility: Local Institution - 001-848a
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Cancer Research - Medical City Hospital
state: Texas
city: Dallas
country: United States
facility: USOR - Texas Oncology - Dallas Fort Worth (DFW) - Presbyterian Cancer Center Dallas
state: Texas
city: Dallas
country: United States
facility: USOR - Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Denison
country: United States
facility: USOR - Texas Oncology Northeast Texas - Denison
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
state: Texas
city: Houston
country: United States
facility: Oncology Consultants - Texas Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Local Institution - 001-935A
state: Texas
city: Irving
country: United States
facility: Local Institution - 001-999
state: Texas
city: Kingwood
country: United States
facility: Local Institution - 001-935D
state: Texas
city: Kingwood
country: United States
facility: Lumi Research
state: Texas
city: Midland
country: United States
facility: USOR - Texas Oncology - Midland Allison Cancer Center
state: Texas
city: San Antonio
country: United States
facility: START Center for Cancer Care
state: Texas
city: Shenandoah
country: United States
facility: Local Institution - 001-935B
state: Texas
city: Spring
country: United States
facility: Local Institution - 001-935C
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology - Sugar Land
state: Texas
city: Tomball
country: United States
facility: Local Institution - 001-935E
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas Cancer and Research Institute - Tyler
state: Texas
city: Waco
country: United States
facility: Texas Oncology - Waco
state: Texas
city: Fairfax
country: United States
facility: Local Institution - 001-919
state: Virginia
city: Fairfax
country: United States
facility: NEXT Virginia
state: Virginia
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg
state: Virginia
city: Newport News
country: United States
facility: USOR - Virginia Oncology Associates - Newport News
state: Virginia
city: Norfolk
country: United States
facility: Local Institution - 001-882-A
state: Virginia
city: Norfolk
country: United States
facility: Local Institution - 001-890-A
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute - West End
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Vancouver
country: United States
facility: USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center
state: Washington
city: Madison
country: United States
facility: University Wisconsin Carbone Cancer Center
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: PanOncology Trials - Rio Piedras Medical Center
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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