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

Primary Purpose

Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MRTX849
Pembrolizumab
Cetuximab
Afatinib
Sponsored by
Mirati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring KRAS, NSCLC, Colorectal Cancer, Colon Cancer, Metastatic Cancer, Pancreatic Cancer, Adagrasib, STK11 mutation, KRAS G12C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Alaska Oncology and HematologyRecruiting
  • Mayo Clinic in ArizonaRecruiting
  • Arizona Oncology AssociatesRecruiting
  • Kaiser Permanente-Bellflower Medical OfficesRecruiting
  • Beverly Hills Cancer CenterRecruiting
  • City of HopeRecruiting
  • St. Joseph Heritage HealthcareRecruiting
  • University of California San Diego Moores Cancer CenterRecruiting
  • Cancer & Blood Specialty ClinicRecruiting
  • Valkyrie Clinical TrialsRecruiting
  • Hoag Memorial Hospital PresbyterianRecruiting
  • University of California, IrvineRecruiting
  • California Cancer Associates for Research and ExcellenceRecruiting
  • Ridley - Tree Cancer Center - Santa BarbaraRecruiting
  • Kaiser PermanenteRecruiting
  • Rocky Mountain Cancer CentersRecruiting
  • University of Colorado HospitalRecruiting
  • SCL Health - Saint Joseph Hospital Cancer Center
  • St. Mary's Hospital & Regional Medical Center - ResearchRecruiting
  • Yale Cancer CenterRecruiting
  • Medical Oncology Hematology ConsultantsRecruiting
  • SCRI - Florida Cancer Specialists- SouthRecruiting
  • Mayo Clinic in FloridaRecruiting
  • Mount Sinai Comprehensive Cancer CenterRecruiting
  • Miami Cancer Institute Baptist HealthRecruiting
  • Florida Cancer Affiliates - OcalaRecruiting
  • Mid Florida Hematology and Oncology CenterRecruiting
  • Woodlands Medical SpecialistsRecruiting
  • BRCR Medical CenterRecruiting
  • SCRI - Florida Cancer Specialists-NorthRecruiting
  • SCRI - Florida Cancer Specialists- EastRecruiting
  • University Cancer and Blood CenterRecruiting
  • Northwest Georgia Oncology Centers, PCRecruiting
  • Affiliated Oncologists - Millenium Medical CenterRecruiting
  • Illinois Cancer Specialists - NilesRecruiting
  • University of Iowa Hospital & ClinicsRecruiting
  • University of Kansas Medical CenterRecruiting
  • University of KentuckyRecruiting
  • SCRI - Hematology Oncology ClinicRecruiting
  • Main Health Cancer Center BiddefordRecruiting
  • Maryland Oncology Hematology-ColumbiaRecruiting
  • Massachusetts General HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Barbara Ann Karmanos Cancer InstituteRecruiting
  • Henry Ford Medical CenterRecruiting
  • Minnesota OncologyRecruiting
  • University of MinnesotaRecruiting
  • Mayo Clinic in MinnesotaRecruiting
  • Metro-Minnesota Community Oncology Research ConsortiumRecruiting
  • Central Care Cancer Center - BolivarRecruiting
  • Goldschmidt Cancer Center- Central Region Medical CenterRecruiting
  • Frontier Cancer CenterRecruiting
  • Nebraska Cancer SpecialistsRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Comprehensive Cancer Centers of NevadaRecruiting
  • New York Oncology Hematology - Albany Medical CenterRecruiting
  • Roswell ParkRecruiting
  • Perlmutter Cancer CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University of North CarolinaRecruiting
  • FirstHealth Outpatient Cancer CenterRecruiting
  • The Christ Hospital Cancer CenterRecruiting
  • University of Cincinnati Health Barrett Cancer CenterRecruiting
  • Cleveland ClinicRecruiting
  • OSU Medical CenterRecruiting
  • SCRI - Mark H. Zangmeister Cancer CenterRecruiting
  • Kettering Cancer Center
  • Cancer Centers of Southwest Oklahoma - Leah M. Fitch Cancer CenterRecruiting
  • St. Charles Health SystemRecruiting
  • Willamette Valley Cancer Institute and Research Center - EugeneRecruiting
  • Lehigh Valley HeathRecruiting
  • Penn State Health Milton S. Hershey Medical CenterRecruiting
  • Charleston Oncology P.A.Recruiting
  • Medical University of South CarolinaRecruiting
  • Tennessee Oncology/The Sarah Cannon Research InstituteRecruiting
  • Texas Oncology-ArlingtonRecruiting
  • USOR - Texas Oncology - Austin CentralRecruiting
  • Mary Crowley Cancer ResearchRecruiting
  • Texas Oncology at Presbyterian DallasRecruiting
  • USOR Texas Oncology Baylor Charles A. Sammons Cancer CenterRecruiting
  • Texas OncologyRecruiting
  • Oncology Consultants - Texas Medical CenterRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Lumi ResearchRecruiting
  • Texas Oncology MidlandRecruiting
  • South Texas Accelerated Research TherapeuticsRecruiting
  • Texas OncologyRecruiting
  • Texas OncologyRecruiting
  • Texas Oncology WacoRecruiting
  • Virginia Cancer SpecialistsRecruiting
  • Hematology Oncology Associates of FredericksburgRecruiting
  • Virginia Oncology Associates-Newport NewsRecruiting
  • Virginia Cancer InstituteRecruiting
  • Seattle Cancer Care AllianceRecruiting
  • USOR - Compass Oncology - VancouverRecruiting
  • University of Wisconsin Carbone Cancer CenterRecruiting
  • PanOncology TrialsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1 Dose Exploration

Phase 1b Expansion

Phase 2

Pilot Phase 1b Combination with Pembrolizumab

Pilot Phase 1b Combination with Cetuximab

Pilot Phase 1b Combination with Afatinib

Phase 2 Combination with Cetuximab

Pilot Phase 1b Combination with Cetuximab in NSCLC

Pilot Phase 1b Combination with Cetuximab in PDAC

Arm Description

Dose escalation of MRTX849 to determine maximum tolerated dose

Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens

Separate cohorts of patients stratified by histological diagnosis, prior treatment history or co-mutation status (e.g., STK11) for evaluation of clinical activity of MRTX849

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with pembrolizumab in patients with NSCLC

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with CRC

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC

Phase 2 evaluation of the clinical activity of MRTX849 in combination with cetuximab in patients with CRC

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with NSCLC

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with pancreatic adenocarcinoma (PDAC)

Outcomes

Primary Outcome Measures

Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation
Number of participants with treatment related adverse events
Evaluate the pharmacokinetics of MRTX849
Blood plasma concentration
Evaluate clinical activity/efficacy of MRTX849
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcome Measures

Establish maximum tolerated dose
Number of participants with dose limiting toxicity
Characterize safety and tolerability of MRTX849 in combination with selected therapeutic agents
Number of participants with dose limiting toxicity
Evaluate the pharmacokinetics of new MRTX849 oral formulations
Blood plasma concentration
Evaluate the pharmacokinetics of MRTX849 administered with food
Blood plasma concentration

Full Information

First Posted
December 18, 2018
Last Updated
January 6, 2023
Sponsor
Mirati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03785249
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirati Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease
Keywords
KRAS, NSCLC, Colorectal Cancer, Colon Cancer, Metastatic Cancer, Pancreatic Cancer, Adagrasib, STK11 mutation, KRAS G12C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
822 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Dose Exploration
Arm Type
Experimental
Arm Description
Dose escalation of MRTX849 to determine maximum tolerated dose
Arm Title
Phase 1b Expansion
Arm Type
Experimental
Arm Description
Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
Separate cohorts of patients stratified by histological diagnosis, prior treatment history or co-mutation status (e.g., STK11) for evaluation of clinical activity of MRTX849
Arm Title
Pilot Phase 1b Combination with Pembrolizumab
Arm Type
Experimental
Arm Description
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with pembrolizumab in patients with NSCLC
Arm Title
Pilot Phase 1b Combination with Cetuximab
Arm Type
Experimental
Arm Description
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with CRC
Arm Title
Pilot Phase 1b Combination with Afatinib
Arm Type
Experimental
Arm Description
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC
Arm Title
Phase 2 Combination with Cetuximab
Arm Type
Experimental
Arm Description
Phase 2 evaluation of the clinical activity of MRTX849 in combination with cetuximab in patients with CRC
Arm Title
Pilot Phase 1b Combination with Cetuximab in NSCLC
Arm Type
Experimental
Arm Description
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with NSCLC
Arm Title
Pilot Phase 1b Combination with Cetuximab in PDAC
Arm Type
Experimental
Arm Description
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with pancreatic adenocarcinoma (PDAC)
Intervention Type
Drug
Intervention Name(s)
MRTX849
Intervention Description
MRTX849 will be administered orally once or twice daily in a continuous regimen
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab is administered as an intravenous infusion once every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Afatinib
Intervention Description
Afatinib will be administered orally once a day in a continuous regimen
Primary Outcome Measure Information:
Title
Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation
Description
Number of participants with treatment related adverse events
Time Frame
20 months
Title
Evaluate the pharmacokinetics of MRTX849
Description
Blood plasma concentration
Time Frame
20 months
Title
Evaluate clinical activity/efficacy of MRTX849
Description
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Establish maximum tolerated dose
Description
Number of participants with dose limiting toxicity
Time Frame
12 months
Title
Characterize safety and tolerability of MRTX849 in combination with selected therapeutic agents
Description
Number of participants with dose limiting toxicity
Time Frame
12 months
Title
Evaluate the pharmacokinetics of new MRTX849 oral formulations
Description
Blood plasma concentration
Time Frame
6 months
Title
Evaluate the pharmacokinetics of MRTX849 administered with food
Description
Blood plasma concentration
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirati Therapeutics Study Locator Services
Phone
1-844-893-5530
Email
miratistudylocator@emergingmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hirak Der-Torossian
Organizational Affiliation
Mirati Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Completed
Facility Name
Alaska Oncology and Hematology
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente-Bellflower Medical Offices
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Individual Site Status
Recruiting
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer & Blood Specialty Clinic
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Valkyrie Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
California Cancer Associates for Research and Excellence
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Individual Site Status
Recruiting
Facility Name
Ridley - Tree Cancer Center - Santa Barbara
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
SCL Health - Saint Joseph Hospital Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Completed
Facility Name
St. Mary's Hospital & Regional Medical Center - Research
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Oncology Hematology Consultants
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Florida Cancer Specialists- South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Cancer Institute Baptist Health
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Affiliates - Ocala
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid Florida Hematology and Oncology Center
City
Orange City
State/Province
Florida
ZIP/Postal Code
37263
Country
United States
Individual Site Status
Recruiting
Facility Name
Woodlands Medical Specialists
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Name
BRCR Medical Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Florida Cancer Specialists-North
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Florida Cancer Specialists- East
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Name
University Cancer and Blood Center
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Georgia Oncology Centers, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Affiliated Oncologists - Millenium Medical Center
City
Chicago Ridge
State/Province
Illinois
ZIP/Postal Code
60415
Country
United States
Individual Site Status
Recruiting
Facility Name
Illinois Cancer Specialists - Niles
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa Hospital & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Hematology Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Name
Main Health Cancer Center Biddeford
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
Country
United States
Individual Site Status
Recruiting
Facility Name
Maryland Oncology Hematology-Columbia
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Individual Site Status
Recruiting
Facility Name
Minnesota Oncology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic in Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Metro-Minnesota Community Oncology Research Consortium
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Care Cancer Center - Bolivar
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Individual Site Status
Recruiting
Facility Name
Goldschmidt Cancer Center- Central Region Medical Center
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Recruiting
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Oncology Hematology - Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Name
Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Name
FirstHealth Outpatient Cancer Center
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Recruiting
Facility Name
The Christ Hospital Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati Health Barrett Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
OSU Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI - Mark H. Zangmeister Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Individual Site Status
Recruiting
Facility Name
Kettering Cancer Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cancer Centers of Southwest Oklahoma - Leah M. Fitch Cancer Center
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73505
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Charles Health System
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Individual Site Status
Recruiting
Facility Name
Willamette Valley Cancer Institute and Research Center - Eugene
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Name
Lehigh Valley Heath
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
Charleston Oncology P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology/The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology-Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Individual Site Status
Recruiting
Facility Name
USOR - Texas Oncology - Austin Central
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology at Presbyterian Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
USOR Texas Oncology Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Consultants - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Lumi Research
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology Midland
City
Midland
State/Province
Texas
ZIP/Postal Code
79701
Country
United States
Individual Site Status
Recruiting
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology Oncology Associates of Fredericksburg
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Oncology Associates-Newport News
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
USOR - Compass Oncology - Vancouver
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Name
PanOncology Trials
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35658005
Citation
Janne PA, Riely GJ, Gadgeel SM, Heist RS, Ou SI, Pacheco JM, Johnson ML, Sabari JK, Leventakos K, Yau E, Bazhenova L, Negrao MV, Pennell NA, Zhang J, Anderes K, Der-Torossian H, Kheoh T, Velastegui K, Yan X, Christensen JG, Chao RC, Spira AI. Adagrasib in Non-Small-Cell Lung Cancer Harboring a KRASG12C Mutation. N Engl J Med. 2022 Jul 14;387(2):120-131. doi: 10.1056/NEJMoa2204619. Epub 2022 Jun 3.
Results Reference
derived
PubMed Identifier
35404402
Citation
Sabari JK, Velcheti V, Shimizu K, Strickland MR, Heist RS, Singh M, Nayyar N, Giobbie-Hurder A, Digumarthy SR, Gainor JF, Rajan AP, Nieblas-Bedolla E, Burns AC, Hallin J, Olson P, Christensen JG, Kurz SC, Brastianos PK, Wakimoto H. Activity of Adagrasib (MRTX849) in Brain Metastases: Preclinical Models and Clinical Data from Patients with KRASG12C-Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2022 Aug 2;28(15):3318-3328. doi: 10.1158/1078-0432.CCR-22-0383.
Results Reference
derived
PubMed Identifier
35167329
Citation
Ou SI, Janne PA, Leal TA, Rybkin II, Sabari JK, Barve MA, Bazhenova L, Johnson ML, Velastegui KL, Cilliers C, Christensen JG, Yan X, Chao RC, Papadopoulos KP. First-in-Human Phase I/IB Dose-Finding Study of Adagrasib (MRTX849) in Patients With Advanced KRASG12C Solid Tumors (KRYSTAL-1). J Clin Oncol. 2022 Aug 10;40(23):2530-2538. doi: 10.1200/JCO.21.02752. Epub 2022 Feb 15.
Results Reference
derived
PubMed Identifier
34161704
Citation
Awad MM, Liu S, Rybkin II, Arbour KC, Dilly J, Zhu VW, Johnson ML, Heist RS, Patil T, Riely GJ, Jacobson JO, Yang X, Persky NS, Root DE, Lowder KE, Feng H, Zhang SS, Haigis KM, Hung YP, Sholl LM, Wolpin BM, Wiese J, Christiansen J, Lee J, Schrock AB, Lim LP, Garg K, Li M, Engstrom LD, Waters L, Lawson JD, Olson P, Lito P, Ou SI, Christensen JG, Janne PA, Aguirre AJ. Acquired Resistance to KRASG12C Inhibition in Cancer. N Engl J Med. 2021 Jun 24;384(25):2382-2393. doi: 10.1056/NEJMoa2105281.
Results Reference
derived

Learn more about this trial

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

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