ACTIVE_NOT_RECRUITING

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

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Conditions

Advanced CancerMetastatic CancerMalignant Neoplastic DiseaseKRASNSCLCColorectal CancerColon CancerPancreatic CancerAdagrasibSTK11 mutationKRAS G12C

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1

Quick Facts

Study Start:2019-01-15
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03785249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
  2. * Unresectable or metastatic disease
  3. * Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
  4. * Adequate organ function
  1. * History of intestinal disease or major gastric surgery or inability to swallow oral medications
  2. * Other active cancer

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 001-826
Birmingham, Alabama, 35294
United States
Local Institution - 001-965
Anchorage, Alaska, 99508
United States
Local Institution - 001-821
Phoenix, Arizona, 85054
United States
Local Institution - 001-873-A
Tucson, Arizona, 85704
United States
Local Institution - 001-873
Tucson, Arizona, 85704
United States
Local Institution - 001-840-B
Bellflower, California, 90706
United States
Local Institution - 001-834
Beverly Hills, California, 90211
United States
Local Institution - 001-843
Duarte, California, 91010
United States
Local Institution - 001-850-K
Dublin, California, 94568
United States
Local Institution - 001-851
Fullerton, California, 92835
United States
Local Institution - 001-840-C
Harbor City, California, 90710
United States
Local Institution - 001-805
La Jolla, California, 92093
United States
Local Institution - 001-779
Los Alamitos, California, 90720
United States
Local Institution - 001-840
Los Angeles, California, 90027
United States
Local Institution - 001-578
Los Angeles, California, 90067
United States
Local Institution - 001-847
Newport Beach, California, 92663
United States
Local Institution - 001-850-B
Oakland, California, 94611
United States
Local Institution - 001-803
Orange, California, 92868
United States
Local Institution - 001-850-C
Roseville, California, 95661
United States
Local Institution - 001-850-J
Sacramento, California, 95814
United States
Local Institution - 001-850-D
Sacramento, California, 95825
United States
Local Institution - 001-845
San Diego, California, 92111
United States
Local Institution - 001-840-A
San Diego, California, 92120
United States
Local Institution - 001-850-H
San Francisco, California, 94080
United States
Local Institution - 001-850-E
San Francisco, California, 94115
United States
Local Institution - 001-850-F
San Jose, California, 95119
United States
Local Institution - 001-850-A
San Leandro, California, 94577
United States
Local Institution - 001-884
Santa Barbara, California, 93105
United States
Local Institution - 001-850-I
Santa Clara, California, 95051
United States
Local Institution - 001-884-A
Solvang, California, 93463
United States
Local Institution - 001-850
Vallejo, California, 94589
United States
Local Institution - 001-850-G
Walnut Creek, California, 94596
United States
Local Institution - 001-872
Aurora, Colorado, 80012
United States
Local Institution - 001-810
Aurora, Colorado, 80045
United States
Local Institution - 001-872-H
Boulder, Colorado, 80303
United States
Local Institution - 001-872-E
Colorado Springs, Colorado, 80907
United States
Local Institution - 001-872-L
Colorado Springs, Colorado, 80920
United States
Local Institution - 001-872-B
Denver, Colorado, 80218
United States
Local Institution - 001-951 - A
Denver, Colorado, 80218
United States
Local Institution - 001-951 - B
Denver, Colorado, 80218
United States
Local Institution - 001-846
Grand Junction, Colorado, 81501
United States
Local Institution - 001-951
Lafayette, Colorado, 80026
United States
Local Institution - 001-872-A
Lakewood, Colorado, 80228
United States
Local Institution - 001-872-D
Littleton, Colorado, 80218
United States
Local Institution - 001-872-K
Lone Tree, Colorado, 80124
United States
Local Institution - 001-872-C
Longmont, Colorado, 80501
United States
Local Institution - 001-872-J
Parker, Colorado, 80138
United States
Local Institution - 001-872-F
Pueblo, Colorado, 81008
United States
Local Institution - 001-872-G
Pueblo, Colorado, 81008
United States
Local Institution - 001-872-I
Thornton, Colorado, 80260
United States
Local Institution - 001-816
New Haven, Connecticut, 06510
United States
Local Institution - 001-871
Newark, Delaware, 19713-2055
United States
Local Institution - 001-929i
Altamonte Springs, Florida, 32701
United States
Local Institution - 001-839
Boca Raton, Florida, 33432
United States
Local Institution - 001-922A
Bonita Springs, Florida, 34135
United States
Local Institution - 001-922D
Bradenton, Florida, 34211
United States
Local Institution - 001-929c
Brandon, Florida, 33511
United States
Local Institution - 001-922E
Cape Coral, Florida, 33909
United States
Local Institution - 001-929g
Clearwater, Florida, 33761
United States
Local Institution - 001-926b
Daytona Beach, Florida, 32117
United States
Local Institution - 001-922
Fort Myers, Florida, 33901
United States
Local Institution - 001-922B
Fort Myers, Florida, 33905
United States
Local Institution - 001-922C
Fort Myers, Florida, 33908
United States
Local Institution - 001-929b
Gainesville, Florida, 32605
United States
Local Institution - 001-829
Jacksonville, Florida, 32224
United States
Local Institution - 001-929m
Lady Lake, Florida, 32159
United States
Local Institution - 001-929e
Largo, Florida, 33770
United States
Local Institution - 001-929n
Lecanto, Florida, 34461
United States
Local Institution - 001-870
Miami, Florida, 33176
United States
Local Institution - 001-825
Miami Beach, Florida, 33140
United States
Local Institution - 001-922F
Naples, Florida, 34102
United States
Local Institution - 001-922G
Naples, Florida, 34102
United States
Local Institution - 001-538
Ocala, Florida, 34474
United States
Local Institution - 001-929p
Ocala, Florida, 34474
United States
Local Institution - 001-914
Orange City, Florida, 32763
United States
Local Institution - 001-929j
Orange City, Florida, 32763
United States
Local Institution - 001-929l
Orlando, Florida, 32806
United States
Local Institution - 001-877
Pensacola, Florida, 32503
United States
Local Institution - 001-922H
Port Charlotte, Florida, 33980
United States
Local Institution - 001-922I
Sarasota, Florida, 34232
United States
Local Institution - 001-922J
Sarasota, Florida, 34236
United States
Local Institution - 001-929h
Spring Hill, Florida, 34608
United States
Local Institution - 001-929a
St. Petersburg, Florida, 33705
United States
Local Institution - 001-929
St. Petersburg, Florida, 33705
United States
Local Institution - 001-926d
Stuart, Florida, 34994
United States
Local Institution - 001-929d
Tampa, Florida, 33607
United States
Local Institution - 001-929k
Tavares, Florida, 32778
United States
Local Institution - 001-929f
Trinity, Florida, 34655
United States
Local Institution - 001-922K
Venice, Florida, 34285
United States
Local Institution - 001-922L
Venice, Florida, 34292
United States
Local Institution - 001-926c
Vero Beach, Florida, 32960
United States
Local Institution - 001-926a
Wellington, Florida, 33414
United States
Local Institution - 001-926
West Palm Beach, Florida, 33401
United States
Local Institution - 001-929o
Winter Park, Florida, 32789
United States
Local Institution - 001-967
Athens, Georgia, 30607
United States
Local Institution - 001-835-C
Austell, Georgia, 30106
United States
Local Institution - 001-835-E
Austell, Georgia, 30106
United States
Local Institution - 001-835-D
Carrollton, Georgia, 30117
United States
Local Institution - 001-835-F
Carrollton, Georgia, 30117
United States
Local Institution - 001-835-A
Cartersville, Georgia, 30121
United States
Local Institution - 001-835-B
Douglasville, Georgia, 30134
United States
Local Institution - 001-835
Marietta, Georgia, 30060
United States
Local Institution - 001-862
Chicago Ridge, Illinois, 60415
United States
Local Institution - 001-883
Niles, Illinois, 60714
United States
Local Institution - 001-781
South Bend, Indiana, 46601
United States
Local Institution - 001-831
Iowa City, Iowa, 52242
United States
Local Institution - 001-820
Westwood, Kansas, 66205
United States
Local Institution - 001-844
Lexington, Kentucky, 40536
United States
Local Institution - 001-920
Baton Rouge, Louisiana, 70809
United States
Local Institution - 001-827
Biddeford, Maine, 04005
United States
Local Institution - 001-881-B
Brandywine, Maryland, 20613
United States
Local Institution - 001-881
Columbia, Maryland, 21044
United States
Local Institution - 001-881-A
Silver Spring, Maryland, 20904
United States
Local Institution - 001-808
Boston, Massachusetts, 02215
United States
Local Institution - 001-842
Detroit, Michigan, 48201
United States
Local Institution - 001-811
Detroit, Michigan, 48202
United States
Local Institution - 001-842-A
Farmington Hills, Michigan, 48334
United States
Local Institution - 001-838-F
Coon Rapids, Minnesota, 55433
United States
Local Institution - 001-838-E
Edina, Minnesota, 55435
United States
Local Institution - 001-875 - D
Edina, Minnesota, 55435
United States
Local Institution - 001-838-D
Maplewood, Minnesota, 55109
United States
Local Institution - 001-875 - A
Maplewood, Minnesota, 55109
United States
Local Institution - 001-838-C
Minneapolis, Minnesota, 55404
United States
Local Institution - 001-875
Minneapolis, Minnesota, 55404
United States
Local Institution - 001-838-G
Minneapolis, Minnesota, 55415
United States
Local Institution - 001-822-A
Minneapolis, Minnesota, 55455
United States
Local Institution - 001-822
Minneapolis, Minnesota, 55455
United States
Local Institution - 001-830
Rochester, Minnesota, 55905
United States
Local Institution - 001-838
Saint Louis Park, Minnesota, 55416
United States
Local Institution - 001-838-B
Saint Louis Park, Minnesota, 55426-5000
United States
Local Institution - 001-838-A
Saint Paul, Minnesota, 55101
United States
Local Institution - 001-875 - B
Saint Paul, Minnesota, 55102
United States
Local Institution - 001-875 - C
Woodbury, Minnesota, 55125
United States
Local Institution - 001-952
Bolivar, Missouri, 65613
United States
Local Institution - 001-950
Jefferson City, Missouri, 65109
United States
Local Institution - 001-841
Billings, Montana, 59102
United States
Local Institution - 001-544B
Omaha, Nebraska, 68105-1850
United States
Local Institution - 001-959
Omaha, Nebraska, 68114
United States
Local Institution - 001-544A
Omaha, Nebraska, 68118
United States
Local Institution - 001-544
Omaha, Nebraska, 68198
United States
Local Institution - 001-860A
Henderson, Nevada, 89052
United States
Local Institution - 001-860C
Henderson, Nevada, 89052
United States
Local Institution - 001-860B
Henderson, Nevada, 89074
United States
Local Institution - 001-860
Henderson, Nevada, 89074
United States
Local Institution - 001-860E
Las Vegas, Nevada, 89128
United States
Local Institution - 001-860D
Las Vegas, Nevada, 89144
United States
Local Institution - 001-860F
Las Vegas, Nevada, 89148
United States
Local Institution - 001-861
Albany, New York, 12206
United States
Local Institution - 001-815
Buffalo, New York, 14203
United States
Local Institution - 001-813
New York, New York, 10016
United States
Local Institution - 001-806
New York, New York, 10065
United States
Local Institution - 001-812
Chapel Hill, North Carolina, 27514
United States
Local Institution - 001-971
Pinehurst, North Carolina, 28374
United States
Local Institution - 001-966
Cincinnati, Ohio, 45219
United States
Local Institution - 001-823
Cincinnati, Ohio, 45267
United States
Local Institution - 001-818
Cleveland, Ohio, 44195
United States
Local Institution - 001-833 - H
Columbus, Ohio, 43201
United States
Local Institution - 001-833 - C
Columbus, Ohio, 43203
United States
Local Institution - 001-833 - J
Columbus, Ohio, 43203
United States
Local Institution - 001-833 - A
Columbus, Ohio, 43210
United States
Local Institution - 001-833 - F
Columbus, Ohio, 43210
United States
Local Institution - 001-833
Columbus, Ohio, 43210
United States
Local Institution - 001-833 - D
Columbus, Ohio, 43212
United States
Local Institution - 001-833 - I
Columbus, Ohio, 43212
United States
Local Institution - 001-930
Columbus, Ohio, 43219
United States
Local Institution - 001-833 - B
Columbus, Ohio, 43221
United States
Local Institution - 001-833 - G
Columbus, Ohio, 43221
United States
Local Institution - 001-833 - E
Gahanna, Ohio, 43230
United States
Local Institution - 001-836-A
Kettering, Ohio, 45429
United States
Local Institution - 001-836
Kettering, Ohio, 45429
United States
Local Institution - 001-600
Lawton, Oklahoma, 73505
United States
Local Institution - 001-584
Tulsa, Oklahoma, 74146
United States
Local Institution - 001-586-A
Bend, Oregon, 97701
United States
Local Institution - 001-586
Bend, Oregon, 97701
United States
Local Institution - 001-889
Eugene, Oregon, 97401
United States
Local Institution - 001-837
Allentown, Pennsylvania, 18103
United States
Local Institution - 001-837-A
Bethlehem, Pennsylvania, 18017
United States
Local Institution - 001-817
Hershey, Pennsylvania, 17033-0850
United States
Local Institution - 001-783
Media, Pennsylvania, 19063
United States
Local Institution - 001-887
Charleston, South Carolina, 29414
United States
Local Institution - 001-819
Charleston, South Carolina, 29425
United States
Local Institution - 001-801-G
Gallatin, Tennessee, 37066
United States
Local Institution - 001-801-A
Hendersonville, Tennessee, 37075
United States
Local Institution - 001-801-D
Hermitage, Tennessee, 37076
United States
Local Institution - 001-801-F
Murfreesboro, Tennessee, 37129
United States
Local Institution - 001-801-B
Nashville, Tennessee, 37203
United States
Local Institution - 001-801
Nashville, Tennessee, 37203
United States
Local Institution - 001-801-E
Nashville, Tennessee, 37207
United States
Local Institution - 001-801-C
Nashville, Tennessee, 37211
United States
Local Institution - 001-888-B
Arlington, Texas, 76012
United States
Local Institution - 001-888
Arlington, Texas, 76012
United States
Local Institution - 001-880
Austin, Texas, 78731
United States
Local Institution - 001-848a
Conroe, Texas, 77384
United States
Local Institution - 001-809
Dallas, Texas, 75230
United States
Local Institution - 001-886
Dallas, Texas, 75231
United States
Local Institution - 001-879
Dallas, Texas, 75246
United States
Local Institution - 001-785
Denison, Texas, 75020
United States
Local Institution - 001-876
Fort Worth, Texas, 76104
United States
Local Institution - 001-848
Houston, Texas, 77030
United States
Local Institution - 001-969
Houston, Texas, 77030
United States
Local Institution - 001-935A
Houston, Texas, 77090
United States
Local Institution - 001-999
Irving, Texas, 75063
United States
Local Institution - 001-935D
Kingwood, Texas, 77339
United States
Local Institution - 001-935
Kingwood, Texas, 77339
United States
Local Institution - 001-554
Midland, Texas, 79701
United States
Local Institution - 001-802
San Antonio, Texas, 78229
United States
Local Institution - 001-935B
Shenandoah, Texas, 77380
United States
Local Institution - 001-935C
Spring, Texas, 77389
United States
Local Institution - 001-874
Sugar Land, Texas, 77479
United States
Local Institution - 001-935E
Tomball, Texas, 77375
United States
Local Institution - 001-878
Tyler, Texas, 75702
United States
Local Institution - 001-890
Waco, Texas, 76712
United States
Local Institution - 001-814
Fairfax, Virginia, 22031
United States
Local Institution - 001-597
Fredericksburg, Virginia, 24408
United States
Local Institution - 001-882
Newport News, Virginia, 23606
United States
Local Institution - 001-882-A
Norfolk, Virginia, 23502
United States
Local Institution - 001-890-A
Norfolk, Virginia, 23502
United States
Local Institution - 001-968
Richmond, Virginia, 23229
United States
Local Institution - 001-824
Seattle, Washington, 98109
United States
Local Institution - 001-885
Vancouver, Washington, 98684
United States
Local Institution - 001-804
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Mirati Therapeutics Inc.

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-15
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2019-01-15
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • KRAS
  • NSCLC
  • Colorectal Cancer
  • Colon Cancer
  • Metastatic Cancer
  • Pancreatic Cancer
  • Adagrasib
  • STK11 mutation
  • KRAS G12C

Additional Relevant MeSH Terms

  • Advanced Cancer
  • Metastatic Cancer
  • Malignant Neoplastic Disease