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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03600883




Registration number
NCT03600883
Ethics application status
Date submitted
26/06/2018
Date registered
26/07/2018
Date last updated
29/06/2020

Titles & IDs
Public title
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreak 100)
Scientific title
A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreak 100)
Secondary ID [1] 0 0
20170543
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
KRAS p.G12C Mutant Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 510

Experimental: 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

Experimental: Dose Expansion Part 2 monotherapy - Upon completing the dose exploration part of the study, dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors Dose expansion in these 2 groups may be done concurrently

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

Experimental: Combination arm with AMG 510 and anti PD-1/L1 - Additional subjects will be enrolled into the combination arm with AMG 510 in combination with an anti (PD-1/L1)

Experimental: Monotherapy treatment naive advanced NSCLC - Separate cohort of part 1 dose expansion patients to evaluate the safety and clinical activity of AMG 510 administered orally once daily in patients with previously untreated advanced NSCLC


Treatment: Drugs: AMG 510
Characterize the pharmacokinetics (PK) of AMG 510 following administration as an oral Tablet formulation

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Abnormal Laboratory Values
Timepoint [1] 0 0
24 Months
Primary outcome [2] 0 0
Number of subjects with clinically significant changes in vital signs.
Timepoint [2] 0 0
24 Months
Primary outcome [3] 0 0
Number of subjects with changes on ECG.
Timepoint [3] 0 0
24 Months
Primary outcome [4] 0 0
Objective response rate (ORR) assessed by RECIST 1.1 criteria of AMG 510 as monotherapy in subjects with KRAS p.G12C mutated advanced tumors
Timepoint [4] 0 0
24 Months
Secondary outcome [1] 0 0
Plasma concentration (Cmax)
Timepoint [1] 0 0
24 Months
Secondary outcome [2] 0 0
Time to achieve Cmax (tmax)
Timepoint [2] 0 0
24 Months
Secondary outcome [3] 0 0
Area under the plasma concentration-time curve (AUC)
Timepoint [3] 0 0
24 Months
Secondary outcome [4] 0 0
Duration of overall response
Timepoint [4] 0 0
24 Months
Secondary outcome [5] 0 0
Progression-free survival
Timepoint [5] 0 0
24 Months
Secondary outcome [6] 0 0
Duration of stable disease
Timepoint [6] 0 0
24 Months

Eligibility
Key inclusion criteria
- Men or women greater than or equal to 18 years old.

- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS
p.G12Cmutation identified through DNA sequencing.
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Randwick
Recruitment hospital [2] 0 0
Research Site - Woolloongabba
Recruitment hospital [3] 0 0
Research Site - Woodville South
Recruitment hospital [4] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
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United States of America
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Delaware
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United States of America
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Florida
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United States of America
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Georgia
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Indiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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United States of America
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Washington
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Austria
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Graz
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Austria
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Innsbruck
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Austria
State/province [24] 0 0
Krems
Country [25] 0 0
Austria
State/province [25] 0 0
Wien
Country [26] 0 0
Belgium
State/province [26] 0 0
Bruxelles
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Belgium
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Edegem
Country [28] 0 0
Belgium
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Gent
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Belgium
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Leuven
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Brazil
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Rio De Janeiro
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Canada
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Alberta
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Canada
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Ontario
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France
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Bordeaux
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France
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Créteil
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France
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Marseille cedex 5
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France
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Paris Cedex 5
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France
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Toulouse cedex 9
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France
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Villejuif
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Germany
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Essen
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Germany
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Köln
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Germany
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München
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Kanagawa
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Japan
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Osaka
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Japan
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Sendai-shi
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Wakayama
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Korea, Republic of
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Seoul
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Switzerland
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Basel
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Switzerland
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Geneve
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Switzerland
State/province [58] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Evaluate the safety and tolerability of AMG 510 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.
Trial website
https://clinicaltrials.gov/show/NCT03600883
Trial related presentations / publications
Canon J, Rex K, Saiki AY, Mohr C, Cooke K, Bagal D, Gaida K, Holt T, Knutson CG, Koppada N, Lanman BA, Werner J, Rapaport AS, San Miguel T, Ortiz R, Osgood T, Sun JR, Zhu X, McCarter JD, Volak LP, Houk BE, Fakih MG, O'Neil BH, Price TJ, Falchook GS, Desai J, Kuo J, Govindan R, Hong DS, Ouyang W, Henary H, Arvedson T, Cee VJ, Lipford JR. The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019 Nov;575(7781):217-223. doi: 10.1038/s41586-019-1694-1. Epub 2019 Oct 30.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03600883