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)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

713

Participants

Timeline

Start Date

August 27, 2018

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
KRAS p.G12C Mutant Advanced Solid Tumors
Interventions
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

DRUG

Midazolam

Administered as an oral hydrochloride (HCI) syrup

Trial Locations (133)

1083

Semmelweis Egyetem, Budapest

1090

Universitaetsklinikum Allgemeines Krankenhaus Wien, Vienna

1121

Orszagos Koranyi Pulmonologiai Intezet, Budapest

1210

Krankenhaus Nord - Klinik Floridsdorf, Vienna

1211

Hopitaux Universitaires de Geneve, Geneva

2031

Scientia Clinical Research Ltd, Randwick

2045

Tudogyogyintezet Torokbalint, Törökbálint

2650

Universitair Ziekenhuis Antwerpen, Edegem

2800

Szent Borbala Korhaz, Tatabánya

3000

Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven

3050

Peter MacCallum Cancer Centre, Parkville

3500

Universitaetsklinikum Krems, Krems

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt

3600

Ziekenhuis Oost-Limburg, Genk

4000

Centre Hospitalier Universitaire de Liege, Liège

4031

Universitaetsspital Basel, Basel

4102

Princess Alexandra Hospital, Woolloongabba

5011

The Queen Elizabeth Hospital, Woodville South

6000

Grand Hopital de Charleroi, Charleroi

6020

Medizinische Universitaet Innsbruck, Innsbruck

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8036

Medizinische Universitaet Graz, Graz

8091

Universitaetsspital Zuerich, Zurich

8800

AZ Delta Campus Rumbeke, Roeselare

9000

Universitair Ziekenhuis Gent, Ghent

10016

Laura and Isaac Perlmutter Cancer Center at New York University Langone, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10408

National Cancer Center, Goyang-si Gyeonggi-do

11526

Henry Dunant Hospital Center, Athens

13385

Hopital de la Timone, Marseille

13620

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do

14263

Roswell Park Cancer Institute, Buffalo

15232

University of Pittsburgh Medical Center Cancer Pavillion, Pittsburgh

18547

Metropolitan Hospital, Athens

19104

University of Pennsylvania, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

19713

Medical Oncology Hematology Consultants Helen F Graham Cancer Center, Newark

20817

American Oncology Partners of Maryland, PA, Bethesda

22031

US Oncology Research Investigational Products Center, Fairfax

Virginia Cancer Specialists PC, Fairfax

24153

Blue Ridge Cancer Care, Salem

27710

Duke University Medical Center, Morris Cancer Clinic, Durham

28009

Hospital General Universitario Gregorio Marañon, Madrid

28027

Clinica Universidad de Navarra, Madrid

28040

Fundacion Jimenez Diaz, Madrid

28050

Hospital Universitario Madrid Sanchinarro, Madrid

29303

Gibbs Cancer Center and Research Institute - Spartanburg, Spartanburg

30322

Winship Cancer Institute, Atlanta

31059

Institut Claudius Regaud, Toulouse

32610

University of Florida Health, Gainesville

32804

AdventHealth Orlando Infusion Center, Orlando

33076

Institut Bergonie, Bordeaux

33612

Moffitt Cancer Center, Tampa

37232

Vanderbilt University Ingram Cancer Center, Nashville

44106

University Hospitals Cleveland Medical Center, Cleveland

44195

Cleveland Clinic, Cleveland

45147

Universitätsklinikum Essen, Essen

46014

Hospital General Universitario de Valencia, Valencia

46202

Indiana University, Indianapolis

48109

University of Michigan, Ann Arbor

48202

Henry Ford Health System, Detroit

50937

Universitatsklinikum Koln, Cologne

54007

Theagenion Cancer Hospital, Thessaloniki

55236

Agios Loukas Clinic, Thessaloniki

71500

University Hospital of Heraklion, Heraklion - Crete

75005

Institut Curie, Paris

75246

Texas Oncology - Baylor, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

77030

University of Texas MD Anderson Cancer Center, Houston

78731

Texas Oncology - Austin Central, Austin

80218

Rocky Mountain Cancer Centers, Denver

Sarah Cannon Research Institute at HealthONE, Denver

81377

Klinikum der Universität München Campus Grosshadern, München

84112

Huntsman Cancer Institute, Salt Lake City

90095

University of California Los Angeles, Los Angeles

90403

Sarcoma Oncology Research Center LLC, Santa Monica

91010

City of Hope National Medical Center, Duarte

94010

Centre Hospitalier Intercommunal de Créteil, Créteil

94115

University of California at SF, San Francisco

94805

Gustave Roussy, Villejuif

98109

Seattle Cancer Care Alliance, Seattle

100337

Spitalul Municipal Ploiesti, Ploieşti

200347

Centrul de Oncologie Sf Nectarie SRL, Craiova

300239

SC Oncomed SRL, Timișoara

400015

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca, Cluj-Napoca

400641

SC Medisprof SRL, Cluj-Napoca

407280

Centrul de Radioterapie Amethyst Cluj, Cluj-Napoca

700483

Institutul Regional de Oncologie Iasi, Iași

06510

Smilow Cancer Hospital at Yale New Haven, New Haven

02114

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

63110-1093

Washington University, St Louis

B-1070

Institut Jules Bordet, Brussels

90050-170

Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer, Porto Alegre

90610-000

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul, Porto Alegre

15090-000

Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto

01308-050

Sociedade Beneficente de Senhoras Hospital Sirio Libanes, São Paulo

04501-000

Oncologia Rede D´Or, São Paulo

20231-050

Instituto Coi, Rio de Janeiro

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

N6A 5W9

London Regional Cancer Program, London Health Sciences Centre, London

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H4A 3J1

McGill University Health Centre Glen Site, Montreal

464-8681

Aichi Cancer Center, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa-shi

791-0280

National Hospital Organization Shikoku Cancer Center, Matsuyama

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

216-8511

St Marianna University Hospital, Kawasaki-shi

241-8515

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center, Yokohama

980-0873

Sendai Kousei Hospital, Sendai

951-8566

Niigata Cancer Center Hospital, Niigata

700-8558

Okayama University Hospital, Okayama

573-1191

Kansai Medical University Hospital, Hirakata-shi

541-8567

Osaka International Cancer Institute, Osaka

411-8777

Shizuoka Cancer Center, Sunto-gun

135-8550

The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku

641-8510

Wakayama Medical University Hospital, Wakayama

1400-038

Fundacao Champalimaud, Lisbon

1769-001

Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente, Lisbon

4464-513

Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano, Matosinhos Municipality

4099-001

Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio, Porto

4100-180

Hospital Cuf porto, Porto

022328

Institutul Oncologic, Prof Dr Alexandru Trestioreanu, Bucharest

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08916

Hospital Universitari Germans Trias i Pujol, Badalona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY