Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Exploration Part 1 monotherapy | Experimental | 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 |
|
| Phase 1 Dose Expansion Part 2 monotherapy | Experimental | 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 |
|
| Phase 1 combination arm with sotorasib and anti PD-1/L1 | Experimental | Additional subjects will be enrolled into the combination arm with sotorasib in combination with an anti (PD-1/L1) |
|
| Phase 1 monotherapy treatment naive advanced NSCLC | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sotorasib | Drug | Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral Tablet formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary: Number of subjects with treatment-emergent adverse events | Treatment-emergent adverse events will be a primary outcome measure for the following groups:
| 24 Months |
| Primary: Number of subjects with treatment-related adverse events | Treatment-related adverse events will be a primary outcome measure for the following groups:
| 24 Months |
| Primary: Number of subjects with grade ≥3 treatment-emergent adverse events | Grade ≥3 treatment-emergent adverse events will be a primary outcome measure in the following group: - Phase 2 monotherapy dose comparison | 24 Months |
| Primary: Number of subjects with serious adverse events | Serious adverse events will be a primary outcome measure in the following group: - Phase 2 monotherapy dose comparison | 24 Months |
| Primary: Number of subjects with adverse events of interest | Adverse events of interest will be a primary outcome measure in the following group: - Phase 2 monotherapy dose comparison | 24 Months |
| Primary: Number of subjects with clinically significant changes in vital signs |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary: Plasma concentration (Cmax) of sotorasib | Cmax will be a secondary outcome measure for the following groups:
| 15 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| University of California Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31666701 | Background | 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. | |
| 34096690 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Phase 2 monotherapy dose comparison | Experimental | Subjects with NSCLC will be enrolled in a dose comparison study evaluating safety and efficacy |
|
| Phase 1 Does escalation and Expansion monotherapy BID | Experimental | BID 2L+solid tumors (fed state) |
|
| Anti PD-1/L1 | Drug | Administered as an intravenous (IV) infusion |
|
| Midazolam | Drug | Administered as an oral hydrochloride (HCI) syrup |
|
Vital signs will be a primary outcome measure for the following groups:
| Baseline to 24 Months |
| Primary: Number of subjects with clinically significant changes in physical examination results | Physical examinations will be a primary outcome measure for the following groups:
| Baseline to 24 Months |
| Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs) | ECGs will be a primary outcome measure for the following groups:
| Baseline to 24 Months |
| Primary: Number of subjects with clinically significant changes in clinical laboratory values | Abnormal clinical laboratory values will be a primary outcome measure for the following groups:
| Baseline to 24 Months |
| Primary: Number of subjects with dose-limiting toxicities (DLTs) | DLTs will be a primary outcome measure for the following groups:
| 21 Days |
| Primary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria | ORR will be a primary outcome measure in the following group:
| 24 Months |
| Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria | DOR will be a primary outcome measure in the following group: - Phase 1 monotherapy treatment naïve advanced NSCLC | 24 Months |
| Primary: Disease control as assessed by RECIST 1.1 criteria | Disease control will be a primary outcome measure in the following group: - Phase 1 monotherapy treatment naïve advanced NSCLC | 24 Months |
| Primary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria | Duration of SD will be a primary outcome measure in the following group: - Phase 1 monotherapy treatment naïve advanced NSCLC | 24 Months |
| Primary: Time to response (TTR) as assessed by RECIST 1.1 criteria | TTR will be a primary outcome measure in the following group: - Phase 1 monotherapy treatment naïve advanced NSCLC | 24 Months |
| Secondary: Plasma concentration (Cmax) of midazolam | 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 | 16 Days |
| Secondary: Time to achieve Cmax (Tmax) of sotorasib | Tmax will be a secondary outcome measure for the following groups:
| 15 Weeks |
| Secondary: Area under the plasma concentration-time curve (AUC) of sotorasib | AUC will be a secondary outcome measure for the following groups:
| 15 Weeks |
| Secondary: Area under the plasma concentration-time curve (AUC) of midazolam | 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 | 16 Days |
| Secondary: Clearance of midazolam from the plasma | 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 | 16 Days |
| Secondary: Terminal half-life (t1/2) of midazolam | 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 | 16 Days |
| Secondary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria | ORR will be a secondary outcome measure for the following groups:
| 24 Months |
| Secondary: Duration of response (DOR) as assessed by RECIST 1.1 criteria | DOR will be a secondary outcome measure for the following groups:
| 24 Months |
| Secondary: Disease control as assessed by RECIST 1.1 criteria | DOR will be a secondary outcome measure for the following groups:
| 24 Months |
| Secondary: Progression-free survival (PFS) as assessed by RECIST 1.1 criteria | PFS will be a secondary outcome measure for the following groups:
| 24 Months |
| Secondary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria | Duration of SD will be a secondary outcome measure for the following groups:
| 24 Months |
| Secondary: Depth of response (best percentage change from baseline in lesion sum diameters) as assessed by RECIST 1.1 criteria | Depth of response will be a secondary outcome measure for the following group: - Phase 2 monotherapy dose comparison | Baseline to 24 Months |
| Secondary: Time to response (TTR) as assessed by RECIST 1.1 criteria | DOR will be a secondary outcome measure for the following groups:
| 24 Months |
| Secondary: Overall survival (OS) | OS will be a secondary outcome measure for the following groups:
| 24 Months |
| Secondary: sotorasib exposure and QTc interval relationship | sotorasib exposure and QTc interval relationship will be a secondary outcome measure for the following groups:
| 24 Months |
| Secondary: Progression-free survival (PFS) at 6 months | PFS at 6 months will be a secondary outcome measure for the following group: - Phase 2 monotherapy | 6 Months |
| Secondary: Progression-free survival (PFS) at 12 months | PFS at 12 months will be a secondary outcome measure for the following group: - Phase 2 monotherapy | 12 Months |
| Secondary: Overall survival (OS) at 12 months | OS at 12 months will be a secondary outcome measure for the following group: - Phase 2 monotherapy | 12 Months |
| Secondary: Number of subjects with treatment-emergent adverse events | Treatment-emergent adverse events will be a secondary outcome measure for the following group: - Phase 2 monotherapy | 24 Months |
| Secondary: Number of subjects with grade ≥3 treatment-emergent adverse events | Grade ≥3 treatment-emergent adverse events will be a secondary outcome measure for the following group: - Phase 2 monotherapy | 24 Months |
| Secondary: Impact of treatment on disease-related symptoms and health related quality of life (HRQOL) as assessed by EORTC QLQ-C30 | 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 Months |
| 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) | 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 Months |
| 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 | 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 Months |
| Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by Patient Global Impression of Severity (PGIS) | 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 Months |
| 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 | 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 Months |
| Secondary: Treatment-related symptoms and impact on the subject as assessed by EORTC QLQ-C30 | Treament related symptoms and impact on the subject will be a secondary outcome measure for the following group: - Phase 2 monotherapy dose comparison | 24 Months |
| 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) | Treatment-related symptoms and impact on the subject will be a secondary outcome measure for the following group: - Phase 2 monotherapy dose comparison | 24 Months |
| 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) | Treatment-related symptoms and impact on the subject will be a secondary outcome measure for the following group: - Phase 2 monotherapy dose comparison | 24 Months |
| Secondary: Change from baseline in physical function as assessed by EORTC QLQ-C30 | Treatment-related symptoms and impact on the subject will be a secondary outcome measure for the following group: - Phase 2 monotherapy dose comparison | Baseline to 24 Months |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California at SF | San Francisco | California | 94115 | United States |
| Sarcoma Oncology Research Center LLC | Santa Monica | California | 90403 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | United States |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06510 | United States |
| Medical Oncology Hematology Consultants Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| University of Florida Health | Gainesville | Florida | 32610 | United States |
| AdventHealth Orlando Infusion Center | Orlando | Florida | 32804 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | 20817 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Washington University | St Louis | Missouri | 63110-1093 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Laura and Isaac Perlmutter Cancer Center at New York University Langone | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center, Morris Cancer Clinic | Durham | North Carolina | 27710 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh Medical Center Cancer Pavillion | Pittsburgh | Pennsylvania | 15232 | United States |
| Gibbs Cancer Center and Research Institute - Spartanburg | Spartanburg | South Carolina | 29303 | United States |
| Vanderbilt University Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Texas Oncology - Austin Central | Austin | Texas | 78731 | United States |
| Texas Oncology - Baylor | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| US Oncology Research Investigational Products Center | Fairfax | Virginia | 22031 | United States |
| Virginia Cancer Specialists PC | Fairfax | Virginia | 22031 | United States |
| Blue Ridge Cancer Care | Salem | Virginia | 24153 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Scientia Clinical Research Ltd | Randwick | New South Wales | 2031 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| The Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Peter MacCallum Cancer Centre | Parkville | Victoria | 3050 | Australia |
| Medizinische Universitaet Graz | Graz | 8036 | Austria |
| Medizinische Universitaet Innsbruck | Innsbruck | 6020 | Austria |
| Universitaetsklinikum Krems | Krems | 3500 | Austria |
| Universitaetsklinikum Allgemeines Krankenhaus Wien | Vienna | 1090 | Austria |
| Krankenhaus Nord - Klinik Floridsdorf | Vienna | 1210 | Austria |
| Institut Jules Bordet | Brussels | B-1070 | Belgium |
| Grand Hopital de Charleroi | Charleroi | 6000 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Jessa Ziekenhuis - Campus Virga Jesse | Hasselt | 3500 | Belgium |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liege | Liège | 4000 | Belgium |
| AZ Delta Campus Rumbeke | Roeselare | 8800 | Belgium |
| Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes | São Paulo | São Paulo | 01308-050 | Brazil |
| Oncologia Rede D´Or | São Paulo | São Paulo | 04501-000 | Brazil |
| Instituto Coi | Rio de Janeiro | 20231-050 | Brazil |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| London Regional Cancer Program, London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Centre Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Hospitalier Intercommunal de Créteil | Créteil | 94010 | France |
| Hopital de la Timone | Marseille | 13385 | France |
| Institut Curie | Paris | 75005 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Universitatsklinikum Koln | Cologne | 50937 | Germany |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Klinikum der Universität München Campus Grosshadern | München | 81377 | Germany |
| Henry Dunant Hospital Center | Athens | 11526 | Greece |
| Metropolitan Hospital | Athens | 18547 | Greece |
| University Hospital of Heraklion | Heraklion - Crete | 71500 | Greece |
| Theagenion Cancer Hospital | Thessaloniki | 54007 | Greece |
| Agios Loukas Clinic | Thessaloniki | 55236 | Greece |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Orszagos Koranyi Pulmonologiai Intezet | Budapest | 1121 | Hungary |
| Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvár | 7400 | Hungary |
| Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár | 8000 | Hungary |
| Szent Borbala Korhaz | Tatabánya | 2800 | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | 2045 | Hungary |
| Aichi Cancer Center | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | Fukuoka | 811-1395 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Sapporo | Hokkaido | 003-0804 | Japan |
| St Marianna University Hospital | Kawasaki-shi | Kanagawa | 216-8511 | Japan |
| Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| Sendai Kousei Hospital | Sendai | Miyagi | 980-0873 | Japan |
| Niigata Cancer Center Hospital | Niigata | Niigata | 951-8566 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 700-8558 | Japan |
| Kansai Medical University Hospital | Hirakata-shi | Osaka | 573-1191 | Japan |
| Osaka International Cancer Institute | Osaka | Osaka | 541-8567 | Japan |
| Shizuoka Cancer Center | Sunto-gun | Shizuoka | 411-8777 | Japan |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-ku | Tokyo | 135-8550 | Japan |
| Wakayama Medical University Hospital | Wakayama | Wakayama | 641-8510 | Japan |
| Fundacao Champalimaud | Lisbon | 1400-038 | Portugal |
| Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente | Lisbon | 1769-001 | Portugal |
| Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano | Matosinhos Municipality | 4464-513 | Portugal |
| Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio | Porto | 4099-001 | Portugal |
| Hospital Cuf porto | Porto | 4100-180 | Portugal |
| Institutul Oncologic, Prof Dr Alexandru Trestioreanu | Bucharest | 022328 | Romania |
| Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca | Cluj-Napoca | 400015 | Romania |
| SC Medisprof SRL | Cluj-Napoca | 400641 | Romania |
| Centrul de Radioterapie Amethyst Cluj | Cluj-Napoca | 407280 | Romania |
| Centrul de Oncologie Sf Nectarie SRL | Craiova | 200347 | Romania |
| Institutul Regional de Oncologie Iasi | Iași | 700483 | Romania |
| Spitalul Municipal Ploiesti | Ploieşti | 100337 | Romania |
| SC Oncomed SRL | Timișoara | 300239 | Romania |
| National Cancer Center | Goyang-si Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 06591 | South Korea |
| Hospital Universitari Germans Trias i Pujol | Badalona | Catalonia | 08916 | Spain |
| Hospital General Universitario de Valencia | Valencia | Valencia | 46014 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28009 | Spain |
| Clinica Universidad de Navarra | Madrid | 28027 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario Madrid Sanchinarro | Madrid | 28050 | Spain |
| Universitaetsspital Basel | Basel | 4031 | Switzerland |
| Hopitaux Universitaires de Geneve | Geneva | 1211 | Switzerland |
| Universitaetsspital Zuerich | Zurich | 8091 | Switzerland |
| Background |
| 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. |
| 34919824 | Background | Fakih MG, Kopetz S, Kuboki Y, Kim TW, Munster PN, Krauss JC, Falchook GS, Han SW, Heinemann V, Muro K, Strickler JH, Hong DS, Denlinger CS, Girotto G, Lee MA, Henary H, Tran Q, Park JK, Ngarmchamnanrith G, Prenen H, Price TJ. Sotorasib for previously treated colorectal cancers with KRASG12C mutation (CodeBreaK100): a prespecified analysis of a single-arm, phase 2 trial. Lancet Oncol. 2022 Jan;23(1):115-124. doi: 10.1016/S1470-2045(21)00605-7. Epub 2021 Dec 15. |
| 32955176 | Background | 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. |
| 34759319 | Background | 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. |
| 37098232 | Background | Dy GK, Govindan R, Velcheti V, Falchook GS, Italiano A, Wolf J, Sacher AG, Takahashi T, Ramalingam SS, Dooms C, Kim DW, Addeo A, Desai J, Schuler M, Tomasini P, Hong DS, Lito P, Tran Q, Jones S, Anderson A, Hindoyan A, Snyder W, Skoulidis F, Li BT. Long-Term Outcomes and Molecular Correlates of Sotorasib Efficacy in Patients With Pretreated KRAS G12C-Mutated Non-Small-Cell Lung Cancer: 2-Year Analysis of CodeBreaK 100. J Clin Oncol. 2023 Jun 20;41(18):3311-3317. doi: 10.1200/JCO.22.02524. Epub 2023 Apr 25. |
| 38010044 | Background | Dy GK, Govindan R, Velcheti V, Falchook GS, Italiano A, Wolf J, Sacher AG, Takahashi T, Ramalingam SS, Dooms C, Kim DW, Addeo A, Desai J, Schuler M, Tomasini P, Hong DS, Lito P, Tran Q, Jones S, Anderson A, Hindoyan A, Snyder W, Skoulidis F, Li BT. Long-term benefit of sotorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: plain language summary. Future Oncol. 2024 Jan;20(3):113-120. doi: 10.2217/fon-2023-0560. Epub 2023 Nov 27. |
| 38975874 | Background | Dilly J, Hoffman MT, Abbassi L, Li Z, Paradiso F, Parent BD, Hennessey CJ, Jordan AC, Morgado M, Dasgupta S, Uribe GA, Yang A, Kapner KS, Hambitzer FP, Qiang L, Feng H, Geisberg J, Wang J, Evans KE, Lyu H, Schalck A, Feng N, Lopez AM, Bristow CA, Kim MP, Rajapakshe KI, Bahrambeigi V, Roth JA, Garg K, Guerrero PA, Stanger BZ, Cristea S, Lowe SW, Baslan T, Van Allen EM, Mancias JD, Chan E, Anderson A, Katlinskaya YV, Shalek AK, Hong DS, Pant S, Hallin J, Anderes K, Olson P, Heffernan TP, Chugh S, Christensen JG, Maitra A, Wolpin BM, Raghavan S, Nowak JA, Winter PS, Dougan SK, Aguirre AJ. Mechanisms of Resistance to Oncogenic KRAS Inhibition in Pancreatic Cancer. Cancer Discov. 2024 Nov 1;14(11):2135-2161. doi: 10.1158/2159-8290.CD-24-0177. |
| 39029295 | Background | Hochmair MJ, Vermaelen K, Mountzios G, Carcereny E, Dooms C, Lee SH, Morocz E, Kato T, Ciuleanu TE, Dy GK, Parente B, O'Byrne KJ, Chu QS, Castro Junior G, Girard N, Snyder W, Tran Q, Kormany W, Houk B, Mehta B, Curioni-Fontecedro A. Sotorasib (960 mg or 240 mg) once daily in patients with previously treated KRAS G12C-mutated advanced NSCLC. Eur J Cancer. 2024 Sep;208:114204. doi: 10.1016/j.ejca.2024.114204. Epub 2024 Jul 5. |
| 39806205 | Background | Nagase M, Houk B, Vuu I, Cardona P, Dutta S, Lin CW. Population Pharmacokinetics of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients Harboring a KRASG12C Mutation from Phase 1 and Phase 2 Studies. AAPS J. 2025 Jan 13;27(1):26. doi: 10.1208/s12248-024-01013-6. |
| 36546651 | Derived | 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. |
| 31820981 | Derived | Lanman BA, Allen JR, Allen JG, Amegadzie AK, Ashton KS, Booker SK, Chen JJ, Chen N, Frohn MJ, Goodman G, Kopecky DJ, Liu L, Lopez P, Low JD, Ma V, Minatti AE, Nguyen TT, Nishimura N, Pickrell AJ, Reed AB, Shin Y, Siegmund AC, Tamayo NA, Tegley CM, Walton MC, Wang HL, Wurz RP, Xue M, Yang KC, Achanta P, Bartberger MD, Canon J, Hollis LS, McCarter JD, Mohr C, Rex K, Saiki AY, San Miguel T, Volak LP, Wang KH, Whittington DA, Zech SG, Lipford JR, Cee VJ. Discovery of a Covalent Inhibitor of KRASG12C (AMG 510) for the Treatment of Solid Tumors. J Med Chem. 2020 Jan 9;63(1):52-65. doi: 10.1021/acs.jmedchem.9b01180. Epub 2019 Dec 24. |
| ID | Term |
|---|---|
| C000706028 | sotorasib |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided