ClinicalTrials.gov
History of Changes for Study: NCT03600883
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
Latest version (submitted May 10, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 17, 2018 None (earliest Version on record)
2 August 7, 2018 Study Status, Eligibility, Arms and Interventions and Study Identification
3 September 14, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 October 29, 2018 Study Status, IPDSharing and Contacts/Locations
5 November 21, 2018 Study Status and Contacts/Locations
6 January 30, 2019 Study Status and Contacts/Locations
7 March 11, 2019 Study Status, Contacts/Locations and Eligibility
8 March 13, 2019 Contacts/Locations and Study Status
9 April 3, 2019 Study Status and Contacts/Locations
10 May 30, 2019 Arms and Interventions, Study Status, Study Identification, Contacts/Locations, Eligibility, Study Design, Conditions and Study Description
11 June 5, 2019 Study Status and Contacts/Locations
12 July 17, 2019 Study Status and Contacts/Locations
13 July 31, 2019 Study Status, Contacts/Locations and Study Design
14 August 21, 2019 Study Status and Contacts/Locations
15 September 19, 2019 Study Status and Contacts/Locations
16 September 25, 2019 Contacts/Locations and Study Status
17 October 9, 2019 Study Status and Contacts/Locations
18 November 27, 2019 Study Status, Arms and Interventions, Outcome Measures, IPDSharing, Contacts/Locations, Study Design and Study Identification
19 December 20, 2019 Study Status, Study Identification, References and Contacts/Locations
20 January 8, 2020 Study Status and Contacts/Locations
21 January 15, 2020 Study Status and Contacts/Locations
22 February 12, 2020 Study Status and Contacts/Locations
23 February 19, 2020 Contacts/Locations and Study Status
24 April 8, 2020 Study Status, Contacts/Locations and Study Design
25 April 15, 2020 Study Status and Contacts/Locations
26 April 29, 2020 Contacts/Locations and Study Status
27 May 6, 2020 Study Status
28 May 13, 2020 Study Status
29 June 10, 2020 Study Status and Contacts/Locations
30 June 12, 2020 Contacts/Locations and Study Status
31 June 25, 2020 Contacts/Locations and Study Status
32 July 23, 2020 Contacts/Locations and Study Status
33 September 16, 2020 Contacts/Locations and Study Status
34 September 21, 2020 Contacts/Locations and Study Status
35 September 23, 2020 Contacts/Locations and Study Status
36 October 1, 2020 Contacts/Locations and Study Status
37 October 30, 2020 Contacts/Locations and Study Status
38 November 13, 2020 Study Status and Contacts/Locations
39 December 11, 2020 Study Status and Contacts/Locations
40 December 14, 2020 Contacts/Locations, Study Status, Eligibility and Arms and Interventions
41 December 29, 2020 Contacts/Locations and Study Status
42 January 15, 2021 Contacts/Locations and Study Status
43 February 11, 2021 Study Status and Contacts/Locations
44 March 12, 2021 Study Status and Contacts/Locations
45 March 25, 2021 Contacts/Locations and Study Status
46 May 7, 2021 Outcome Measures, Contacts/Locations, Arms and Interventions, Study Status, Study Design and Study Identification
47 May 21, 2021 Contacts/Locations and Study Status
48 May 26, 2021 Contacts/Locations and Study Status
49 May 28, 2021 Study Status
50 June 4, 2021 Contacts/Locations and Study Status
51 July 1, 2021 Study Status and References
52 July 7, 2021 Contacts/Locations and Study Status
53 July 14, 2021 Study Status and Contacts/Locations
54 August 3, 2021 Study Status
55 August 11, 2021 Study Status and Contacts/Locations
56 September 1, 2021 Study Status and Contacts/Locations
57 October 15, 2021 Study Status, Contacts/Locations and Outcome Measures
58 October 27, 2021 Study Status and Contacts/Locations
59 November 3, 2021 Study Status and Contacts/Locations
60 November 12, 2021 Study Status and Contacts/Locations
61 November 24, 2021 Contacts/Locations and Study Status
62 December 22, 2021 Contacts/Locations and Study Status
63 December 29, 2021 Contacts/Locations and Study Status
64 January 19, 2022 Study Status and Contacts/Locations
65 January 26, 2022 Contacts/Locations and Study Status
66 February 18, 2022 Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures, Study Identification, Study Design and Study Description
67 June 1, 2022 Study Status and References
68 June 22, 2022 Study Status
69 September 1, 2022 Study Status, References and Contacts/Locations
70 September 21, 2022 Contacts/Locations and Study Status
71 September 30, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
72 October 12, 2022 Study Status
73 November 14, 2022 Study Status
74 January 9, 2023 Study Status and References
75 March 24, 2023 Study Status
76 May 19, 2023 Study Status
77 October 23, 2023 Study Status and Arms and Interventions
78 February 22, 2024 Study Status and References
79 May 10, 2024 Study Status and References
Comparison Format:
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Study NCT03600883
Submitted Date:  January 9, 2023 (v74)
Open or close this module Study Identification
Unique Protocol ID: 20170543
Brief Title: A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
Official Title: A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2023
Overall Status: Active, not recruiting
Study Start: August 27, 2018
Primary Completion: May 22, 2026 [Anticipated]
Study Completion: May 22, 2026 [Anticipated]
First Submitted: June 26, 2018
First Submitted that
Met QC Criteria:		 July 17, 2018
First Posted: July 26, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:		 January 9, 2023
Last Update Posted: January 11, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Amgen
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Detailed Description:
Open or close this module Conditions
Conditions: KRAS p.G12C Mutant Advanced Solid Tumors
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
Number of Arms: 6
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 713 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Phase 1 Dose Exploration Part 1 monotherapy

Cohorts with food effect and alternative dosing regimens

Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 2-4 subjects treated at the lowest planned dose level of 180 mg. If no DLT is observed, dose escalation will continue to the next planned dose cohort

 Drug: sotorasib
Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral Tablet formulation
Experimental: Phase 1 Dose Expansion Part 2 monotherapy
Upon completing the dose exploration part of the study, dose expansion may proceed with 3 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 3 groups may be done concurrently
 Drug: sotorasib
Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral Tablet formulation
Experimental: Phase 2 monotherapy
Additional subjects will be enrolled in the dose expansion to confirm the recommended phase 2 dose. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose
 Drug: sotorasib
Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral Tablet formulation
Experimental: Phase 1 combination arm with sotorasib and anti PD-1/L1
Additional subjects will be enrolled into the combination arm with sotorasib in combination with an anti (PD-1/L1)
 Drug: sotorasib
Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral Tablet formulation
Drug: Anti PD-1/L1
Administered as an intravenous (IV) infusion
Experimental: Phase 1 monotherapy treatment naive advanced NSCLC
Separate cohort of part 1 dose expansion subjects to evaluate the safety and clinical activity of sotorasib administered orally once daily in subjects with previously untreated advanced non-small cell lung cancer (NSCLC). Drug-drug interaction will be evaluated in 6 of the subjects enrolled in the treatment naive cohort by adding Midazolam alone on Day -1 and in combination with sotorasib on Day 15 of Cycle 1, where each cycle is 21 days.
 Drug: sotorasib
Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral Tablet formulation
Drug: Midazolam
Administered as an oral hydrochloride (HCI) syrup
Experimental: Phase 2 monotherapy dose comparison
Subjects with NSCLC will be enrolled in a dose comparison study evaluating safety and efficacy
 Drug: sotorasib
Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral Tablet formulation
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Primary: Number of subjects with treatment-emergent adverse events
[ Time Frame: 24 Months ]

Treatment-emergent adverse events will be a primary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 1 monotherapy treatment naïve advanced NSCLC
  • Phase 2 monotherapy dose comparison
2. Primary: Number of subjects with treatment-related adverse events
[ Time Frame: 24 Months ]

Treatment-related adverse events will be a primary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 1 monotherapy treatment naïve advanced NSCLC
3. Primary: Number of subjects with grade ≥3 treatment-emergent adverse events
[ Time Frame: 24 Months ]

Grade ≥3 treatment-emergent adverse events will be a primary outcome measure in the following group:

- Phase 2 monotherapy dose comparison
4. Primary: Number of subjects with serious adverse events
[ Time Frame: 24 Months ]

Serious adverse events will be a primary outcome measure in the following group:

- Phase 2 monotherapy dose comparison
5. Primary: Number of subjects with adverse events of interest
[ Time Frame: 24 Months ]

Adverse events of interest will be a primary outcome measure in the following group:

- Phase 2 monotherapy dose comparison
6. Primary: Number of subjects with clinically significant changes in vital signs
[ Time Frame: Baseline to 24 Months ]

Vital signs will be a primary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 1 monotherapy treatment naïve advanced NSCLC
7. Primary: Number of subjects with clinically significant changes in physical examination results
[ Time Frame: Baseline to 24 Months ]

Physical examinations will be a primary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
8. Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs)
[ Time Frame: Baseline to 24 Months ]

ECGs will be a primary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 1 monotherapy treatment naïve advanced NSCLC
9. Primary: Number of subjects with clinically significant changes in clinical laboratory values
[ Time Frame: Baseline to 24 Months ]

Abnormal clinical laboratory values will be a primary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 1 monotherapy treatment naïve advanced NSCLC
10. Primary: Number of subjects with dose-limiting toxicities (DLTs)
[ Time Frame: 21 Days ]

DLTs will be a primary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 1 monotherapy treatment naïve advanced NSCLC
11. Primary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

ORR will be a primary outcome measure in the following group:

  • Phase 1 monotherapy treatment naïve advanced NSCLC
  • Phase 2 monotherapy
  • Phase 2 monotherapy dose comparison
12. Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

DOR will be a primary outcome measure in the following group:

- Phase 1 monotherapy treatment naïve advanced NSCLC
13. Primary: Disease control as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

Disease control will be a primary outcome measure in the following group:

- Phase 1 monotherapy treatment naïve advanced NSCLC
14. Primary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

Duration of SD will be a primary outcome measure in the following group:

- Phase 1 monotherapy treatment naïve advanced NSCLC
15. Primary: Time to response (TTR) as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

TTR will be a primary outcome measure in the following group:

- Phase 1 monotherapy treatment naïve advanced NSCLC
Secondary Outcome Measures:
1. Secondary: Plasma concentration (Cmax) of sotorasib
[ Time Frame: 15 Weeks ]

Cmax will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 1 monotherapy treatment naïve advanced NSCLC
  • Phase 2 monotherapy dose comparison
2. Secondary: Plasma concentration (Cmax) of midazolam
[ Time Frame: 16 Days ]

Cmax of midazolam will be a secondary outcome measure for the subgroup of subjects who were administered midazolam in the following group:

- Phase 1 monotherapy treatment naïve advanced NSCLC
3. Secondary: Time to achieve Cmax (Tmax) of sotorasib
[ Time Frame: 15 Weeks ]

Tmax will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 1 monotherapy treatment naïve advanced NSCLC
4. Secondary: Area under the plasma concentration-time curve (AUC) of sotorasib
[ Time Frame: 15 Weeks ]

AUC will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 1 monotherapy treatment naïve advanced NSCLC
  • Phase 2 monotherapy dose comparison
5. Secondary: Area under the plasma concentration-time curve (AUC) of midazolam
[ Time Frame: 16 Days ]

AUC of midazolam will be a secondary outcome measure for the subgroup of subjects who were administered midazolam in the following group:

- Phase 1 monotherapy treatment naïve advanced NSCLC
6. Secondary: Clearance of midazolam from the plasma
[ Time Frame: 16 Days ]

Clearance of midazolam from the plasma will be a secondary outcome measure for the subgroup of subjects who were administered midazolam in the following group:

- Phase 1 monotherapy treatment naïve advanced NSCLC
7. Secondary: Terminal half-life (t1/2) of midazolam
[ Time Frame: 16 Days ]

t1/2 of midazolam will be a secondary outcome measure for the subgroup of subjects who were administered midazolam in the following group:

- Phase 1 monotherapy treatment naïve advanced NSCLC
8. Secondary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

ORR will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
9. Secondary: Duration of response (DOR) as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

DOR will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 2 monotherapy dose comparison
10. Secondary: Disease control as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

DOR will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 2 monotherapy dose comparison
11. Secondary: Progression-free survival (PFS) as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

PFS will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 2 monotherapy dose comparison
  • Phase 1 monotherapy treatment naïve advanced NSCLC
12. Secondary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

Duration of SD will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
13. Secondary: Depth of response (best percentage change from baseline in lesion sum diameters) as assessed by RECIST 1.1 criteria
[ Time Frame: Baseline to 24 Months ]

Depth of response will be a secondary outcome measure for the following group:

- Phase 2 monotherapy dose comparison
14. Secondary: Time to response (TTR) as assessed by RECIST 1.1 criteria
[ Time Frame: 24 Months ]

DOR will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 2 monotherapy dose comparison
15. Secondary: Overall survival (OS)
[ Time Frame: 24 Months ]

OS will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
  • Phase 2 monotherapy
  • Phase 1 combination arm with sotorasib and anti PD-1/L1
  • Phase 2 monotherapy dose comparison
  • Phase 1 monotherapy treatment naïve advanced NSCLC
16. Secondary: sotorasib exposure and QTc interval relationship
[ Time Frame: 24 Months ]

sotorasib exposure and QTc interval relationship will be a secondary outcome measure for the following groups:

  • Phase 1 Dose Exploration Part 1 monotherapy
  • Phase 1 Dose Expansion Part 2 monotherapy
17. Secondary: Progression-free survival (PFS) at 6 months
[ Time Frame: 6 Months ]

PFS at 6 months will be a secondary outcome measure for the following group:

- Phase 2 monotherapy
18. Secondary: Progression-free survival (PFS) at 12 months
[ Time Frame: 12 Months ]

PFS at 12 months will be a secondary outcome measure for the following group:

- Phase 2 monotherapy
19. Secondary: Overall survival (OS) at 12 months
[ Time Frame: 12 Months ]

OS at 12 months will be a secondary outcome measure for the following group:

- Phase 2 monotherapy
20. Secondary: Number of subjects with treatment-emergent adverse events
[ Time Frame: 24 Months ]

Treatment-emergent adverse events will be a secondary outcome measure for the following group:

- Phase 2 monotherapy
21. Secondary: Number of subjects with grade ≥3 treatment-emergent adverse events
[ Time Frame: 24 Months ]

Grade ≥3 treatment-emergent adverse events will be a secondary outcome measure for the following group:

- Phase 2 monotherapy
22. Secondary: Impact of treatment on disease-related symptoms and health related quality of life (HRQOL) as assessed by EORTC QLQ-C30
[ Time Frame: 24 Months ]

Impact of treatment on disease-related symptoms and HRQOL will be a secondary outcome measure for the following group:

- Phase 2 monotherapy dose comparison
23. Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by disease-specific modules Quality-of-Life Questionnaire Lung Cancer Module (QLQ LC13)
[ Time Frame: 24 Months ]

Impact of treatment on disease-related symptoms and HRQOL will be a secondary outcome measure for the following group:

- Phase 2 monotherapy dose comparison
24. Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by non-small cell lung cancer symptom assessment questionnaire (NSCLC SAQ) for NSCLC
[ Time Frame: 24 Months ]

Impact of treatment on disease-related symptoms and HRQOL will be a secondary outcome measure for the following group:

- Phase 2 monotherapy dose comparison
25. Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by Patient Global Impression of Severity (PGIS)
[ Time Frame: 24 Months ]

Impact of treatment on disease-related symptoms and HRQOL will be a secondary outcome measure for the following group:

- Phase 2 monotherapy dose comparison
26. Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by Patient Global Impression of Change (PGIC) in cough, dyspnea and chest pain for NSCLC
[ Time Frame: 24 Months ]

Impact of treatment on disease-related symptoms and HRQOL will be a secondary outcome measure for the following group:

- Phase 2 monotherapy dose comparison
27. Secondary: Treatment-related symptoms and impact on the subject as assessed by EORTC QLQ-C30
[ Time Frame: 24 Months ]

Treament related symptoms and impact on the subject will be a secondary outcome measure for the following group:

- Phase 2 monotherapy dose comparison
28. Secondary: Treatment-related symptoms and impact on the subject as assessed by selected questions from the Patient-reported Outcome of the Common Terminology Criteria for Adverse Events (PRO-CTCAE library)
[ Time Frame: 24 Months ]

Treatment-related symptoms and impact on the subject will be a secondary outcome measure for the following group:

- Phase 2 monotherapy dose comparison
29. Secondary: Treatment-related symptoms and impact on the subject as assessed by a single item about symptom bother, item GP5 of the Functional Assessment of Cancer Therapy - General (FACT-G)
[ Time Frame: 24 Months ]

Treatment-related symptoms and impact on the subject will be a secondary outcome measure for the following group:

- Phase 2 monotherapy dose comparison
30. Secondary: Change from baseline in physical function as assessed by EORTC QLQ-C30
[ Time Frame: Baseline to 24 Months ]

Treatment-related symptoms and impact on the subject will be a secondary outcome measure for the following group:

- Phase 2 monotherapy dose comparison
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 100 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.

Exclusion Criteria

  • Active brain metastases from non-brain tumors.
  • Myocardial infarction within 6 months of study day 1.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Open or close this module Contacts/Locations
Study Officials: MD
Study Director
Amgen
Locations: United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
University of California Los Angeles
Los Angeles, California, United States, 90095
University of California at SF
San Francisco, California, United States, 94115
Sarcoma Oncology Research Center LLC
Santa Monica, California, United States, 90403
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
United States, Connecticut
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06510
United States, Delaware
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
United States, Florida
University of Florida Health
Gainesville, Florida, United States, 32610
AdventHealth Orlando Infusion Center
Orlando, Florida, United States, 32804
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Maryland
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110-1093
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Laura and Isaac Perlmutter Cancer Center at New York University Langone
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center, Morris Cancer Clinic
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Gibbs Cancer Center and Research Institute - Spartanburg
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Vanderbilt University Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology - Austin Central
Austin, Texas, United States, 78731
Texas Oncology - Baylor
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
US Oncology Research Investigational Products Center
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists PC
Fairfax, Virginia, United States, 22031
Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, New South Wales
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Peter MacCallum Cancer Centre
Parkville, Victoria, Australia, 3050
Austria
Medizinische Universitaet Graz
Graz, Austria, 8036
Medizinische Universitaet Innsbruck
Innsbruck, Austria, 6020
Universitaetsklinikum Krems
Krems, Austria, 3500
Universitaetsklinikum Allgemeines Krankenhaus Wien
Wien, Austria, 1090
Krankenhaus Nord - Klinik Floridsdorf
Wien, Austria, 1210
Belgium
Institut Jules Bordet
Brussels, Belgium, B-1070
Grand Hopital de Charleroi
Charleroi, Belgium, 6000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Belgium, 3500
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Centre Hospitalier Universitaire de Liege
Liege, Belgium, 4000
AZ Delta Campus Rumbeke
Roeselare, Belgium, 8800
Brazil
Instituto Coi
Rio de Janeiro, Brazil, 20231-050
Brazil, Rio Grande Do Sul
Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer
Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Brazil, São Paulo
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Sao Paulo, São Paulo, Brazil, 01308-050
Oncologia Rede D´Or
Sao Paulo, São Paulo, Brazil, 04501-000
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15090-000
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University Health Centre Glen Site
Montreal, Quebec, Canada, H4A 3J1
France
Institut Bergonie
Bordeaux, France, 33076
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94010
Hopital de la Timone
Marseille cedex 5, France, 13385
Institut Curie
Paris, France, 75005
Institut Claudius Regaud
Toulouse cedex 9, France, 31059
Gustave Roussy
Villejuif, France, 94805
Germany
Universitätsklinikum Essen
Essen, Germany, 45147
Universitatsklinikum Koln
Köln, Germany, 50937
Klinikum der Universität München Campus Grosshadern
München, Germany, 81377
Greece
Henry Dunant Hospital Center
Athens, Greece, 11526
Metropolitan Hospital
Athens, Greece, 18547
University Hospital of Heraklion
Heraklion - Crete, Greece, 71500
Theagenion Cancer Hospital
Thessaloniki, Greece, 54007
Agios Loukas Clinic
Thessaloniki, Greece, 55236
Hungary
Semmelweis Egyetem
Budapest, Hungary, 1083
Orszagos Koranyi Pulmonologiai Intezet
Budapest, Hungary, 1121
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvar, Hungary, 7400
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Szekesfehervar, Hungary, 8000
Szent Borbala Korhaz
Tatabanya, Hungary, 2800
Tudogyogyintezet Torokbalint
Torokbalint, Hungary, 2045
Japan, Aichi
Aichi Cancer Center
Nagoya-shi, Aichi, Japan, 464-8681
Japan, Chiba
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Japan, Ehime
National Hospital Organization Shikoku Cancer Center
Matsuyama-shi, Ehime, Japan, 791-0280
Japan, Fukuoka
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi, Fukuoka, Japan, 811-1395
Japan, Hokkaido
National Hospital Organization Hokkaido Cancer Center
Sapporo-shi, Hokkaido, Japan, 003-0804
Japan, Kanagawa
St Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan, 216-8511
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama-shi, Kanagawa, Japan, 241-8515
Japan, Miyagi
Sendai Kousei Hospital
Sendai-shi, Miyagi, Japan, 980-0873
Japan, Niigata
Niigata Cancer Center Hospital
Niigata-shi, Niigata, Japan, 951-8566
Japan, Okayama
Okayama University Hospital
Okayama-shi, Okayama, Japan, 700-8558
Japan, Osaka
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan, 573-1191
Osaka International Cancer Institute
Osaka-shi, Osaka, Japan, 541-8567
Japan, Shizuoka
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 411-8777
Japan, Tokyo
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan, 135-8550
Japan, Wakayama
Wakayama Medical University Hospital
Wakayama-shi, Wakayama, Japan, 641-8510
Korea, Republic of
National Cancer Center
Goyang-si Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
The Catholic University of Korea Seoul St Marys Hospital
Seoul, Korea, Republic of, 06591
Portugal
Fundacao Champalimaud
Lisboa, Portugal, 1400-038
Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
Lisboa, Portugal, 1769-001
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos, Portugal, 4464-513
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
Porto, Portugal, 4099-001
Hospital Cuf porto
Porto, Portugal, 4100-180
Romania
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucuresti, Romania, 022328
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj Napoca, Romania, 400015
SC Medisprof SRL
Cluj Napoca, Romania, 400641
Centrul de Radioterapie Amethyst Cluj
Cluj Napoca, Romania, 407280
Centrul de Oncologie Sf Nectarie SRL
Craiova, Romania, 200347
Institutul Regional de Oncologie Iasi
Iasi, Romania, 700483
Spitalul Municipal Ploiesti
Ploiesti, Romania, 100337
SC Oncomed SRL
Timisoara, Romania, 300239
Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28009
Clinica Universidad de Navarra
Madrid, Spain, 28027
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Hospital Universitario Madrid Sanchinarro
Madrid, Spain, 28050
Spain, Cataluña
Hospital Universitari Germans Trias i Pujol
Badalona, Cataluña, Spain, 08916
Spain, Comunidad Valenciana
Hospital General Universitario de Valencia
Valencia, Comunidad Valenciana, Spain, 46014
Switzerland
Universitaetsspital Basel
Basel, Switzerland, 4031
Hopitaux Universitaires de Geneve
Geneve, Switzerland, 1211
Universitaetsspital Zuerich
Zurich, Switzerland, 8091
Open or close this module IPDSharing
Plan to Share IPD: Yes
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame:
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria:
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing
Open or close this module References
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Skoulidis F, Li BT, Dy GK, Price TJ, Falchook GS, Wolf J, Italiano A, Schuler M, Borghaei H, Barlesi F, Kato T, Curioni-Fontecedro A, Sacher A, Spira A, Ramalingam SS, Takahashi T, Besse B, Anderson A, Ang A, Tran Q, Mather O, Henary H, Ngarmchamnanrith G, Friberg G, Velcheti V, Govindan R. Sotorasib for Lung Cancers with KRAS p.G12C Mutation. N Engl J Med. 2021 Jun 24;384(25):2371-2381. doi: 10.1056/NEJMoa2103695. Epub 2021 Jun 4. PubMed 34096690
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Hong DS, Fakih MG, Strickler JH, Desai J, Durm GA, Shapiro GI, Falchook GS, Price TJ, Sacher A, Denlinger CS, Bang YJ, Dy GK, Krauss JC, Kuboki Y, Kuo JC, Coveler AL, Park K, Kim TW, Barlesi F, Munster PN, Ramalingam SS, Burns TF, Meric-Bernstam F, Henary H, Ngang J, Ngarmchamnanrith G, Kim J, Houk BE, Canon J, Lipford JR, Friberg G, Lito P, Govindan R, Li BT. KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med. 2020 Sep 24;383(13):1207-1217. doi: 10.1056/NEJMoa1917239. Epub 2020 Sep 20. PubMed 32955176
Zhao Y, Murciano-Goroff YR, Xue JY, Ang A, Lucas J, Mai TT, Da Cruz Paula AF, Saiki AY, Mohn D, Achanta P, Sisk AE, Arora KS, Roy RS, Kim D, Li C, Lim LP, Li M, Bahr A, Loomis BR, de Stanchina E, Reis-Filho JS, Weigelt B, Berger M, Riely G, Arbour KC, Lipford JR, Li BT, Lito P. Diverse alterations associated with resistance to KRAS(G12C) inhibition. Nature. 2021 Nov;599(7886):679-683. doi: 10.1038/s41586-021-04065-2. Epub 2021 Nov 10. PubMed 34759319
Strickler JH, Satake H, George TJ, Yaeger R, Hollebecque A, Garrido-Laguna I, Schuler M, Burns TF, Coveler AL, Falchook GS, Vincent M, Sunakawa Y, Dahan L, Bajor D, Rha SY, Lemech C, Juric D, Rehn M, Ngarmchamnanrith G, Jafarinasabian P, Tran Q, Hong DS. Sotorasib in KRAS p.G12C-Mutated Advanced Pancreatic Cancer. N Engl J Med. 2023 Jan 5;388(1):33-43. doi: 10.1056/NEJMoa2208470. Epub 2022 Dec 21. PubMed 36546651
Links: Description: AmgenTrials clinical trials website
Available IPD/Information:
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