Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

610

Participants

Timeline

Start Date

December 17, 2019

Primary Completion Date

December 17, 2026

Study Completion Date

December 5, 2027

Conditions
Advanced Solid TumorsKirsten Rat Sarcoma (KRAS) pG12C Mutation
Interventions
DRUG

Sotorasib

Sotorasib administered orally as a tablet.

DRUG

Trametinib

Trametinib administered orally as a tablet.

DRUG

RMC-4630

RMC-4630 administered orally as a capsule.

DRUG

Afatinib

afatinib administered orally as a tablet.

DRUG

Pembrolizumab

pembrolizumab administered as an intravenous (IV) infusion.

DRUG

Panitumumab

Panitumumab administered as an IV infusion.

DRUG

Carboplatin, pemetrexed, docetaxel, paclitaxel

Carboplatin, pemetrexed, docetaxel administered as an IV infusion.

DRUG

Atezolizumab

Atezolizumab administered as an IV injection.

DRUG

Palbociclib

Palbociclib administered orally as a tablet.

DRUG

MVASI® (bevacizumab-awwb)

MVASI® (bevacizumab-awwb) administered as an IV infusion.

DRUG

TNO155

TNO155 administered orally as a capsule.

DRUG

IV Chemotherapy (Regimen 1)

Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.

DRUG

IV Chemotherapy (Regimen 2)

IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.

DRUG

BI 1701963

BI 1701963 administered orally

DRUG

AMG 404

AMG 404 administered as an IV infusion.

DRUG

Everolimus

Everolimus administered orally.

Trial Locations (90)

1200

Universite Catholique de Louvain Cliniques Universitaires Saint Luc, Brussels

2065

GenesisCare -North Shore Oncology, St Leonards

2650

Universitair Ziekenhuis Antwerpen, Edegem

2747

Nepean Cancer Centre, Kingswood

4101

Icon Cancer Care South Brisbane, South Brisbane

5011

The Queen Elizabeth Hospital, Woodville South

5020

Landeskrankenhaus Salzburg, Salzburg

6008

St John of God Healthcare, Subiaco

8036

Medizinische Universitaet Graz, Graz

10002

National Taiwan University Hospital, Taipei

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Irving Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10461

Montefiore Medical Center, The Bronx

11217

Taipei Veterans General Hospital, Taipei

13353

Charite Universitaetsmedizin Berlin, Campus Virchow, Berlin

15232

University of Pittsburgh Medical Center, Pittsburgh

19107

Thomas Jefferson University, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

University of Pennsylvania, Philadelphia

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

21224

Johns Hopkins University, Baltimore

22031

Virginia Cancer Specialists, PC, Fairfax

22903

University of Virginia Cancer Center, Charlottesville

27710

Duke University, Durham

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28204

Levine Cancer Institute, Charlotte

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

29303

Gibbs Cancer Center and Research Institute - Spartanburg, Spartanburg

30322

Emory University, Atlanta

32224

Roswell Park Cancer Institute, Buffalo

33028

Memorial Cancer Institute, Pembroke Pines

33305

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation, Taoyuan District

33612

Moffitt Cancer Center, Tampa

37126

Centro Ricerche Cliniche Di Verona Societa responsabilita limitata, Verona

37203

United States Oncology Regulatory Affairs Corporate Office, Nashville

37232

Vanderbilt University Medical Center, Nashville

44195

Cleveland Clinic Foundation, Cleveland

45147

Universitaetsklinikum Essen, Essen

45267

University of Cincinnati Medical Center, Cincinnati

46202

Indiana University, Indianapolis

48202

Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion), Detroit

50937

Universitatsklinikum Koln, Cologne

52242

University of Iowa Hospitals and Clinics, Iowa City

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

57108

Avera Cancer Institute, Sioux Falls

60611

Northwestern University, Chicago

60637

University of Chicago, Chicago

70403

National Cheng Kung University Hospital, Tainan City

75230

Mary Crowley Cancer Research, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

75702

Texas Oncology Northeast Texas, Tyler

77030

Oncology Consultants, Houston

University of Texas MD Anderson Cancer Center, Houston

77380

US Oncology Research Investigational Products Center, The Woodlands

78705

Texas Oncology Central-South, Austin

80218

Rocky Mountain Cancer Centers Denver Midtown, Denver

Sarah Cannon Research Institute, Denver

84112

Huntsman Cancer Institute, Salt Lake City

85711

Arizona Oncology Associates Professional Corporation, Tucson

90033

University of Southern California, Norris Comprehensive Cancer Center, Los Angeles

90404

University of California Los Angeles, Santa Monica

91010

City of Hope National Medical Center, Duarte

92093

University of California San Diego Moores Cancer Center, La Jolla

92354

Loma Linda University Cancer Center, Loma Linda

94115

University of California San Francisco Mission Bay Campus, San Francisco

95817

University of California Davis Medical Center, Sacramento

97213

Providence Portland Medical Center, Portland

97239

Oregon Health and Science University, Portland

98109

Fred Hutchinson Cancer Center, Seattle

98405

Northwest Medical Specialties, PLLC, Tacoma

98684

Northwest Cancer Specialists - Vancouver, Vancouver

06520

Yale New Haven Hospital, New Haven

06856

Norwalk Hospital, Norwalk

48109-5912

University of Michigan, Ann Arbor

63110-1093

Washington University, St Louis

G1J 1Z4

CHU de Quebec Hopital de l Enfant Jesus, Québec

01307

Universitaetsklinikum Dresden, Dresden

464-8681

Aichi Cancer Center, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa-shi

135-8550

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

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

03080

Seoul National University Hospital, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

138-736

Asan Medical Center, Seoul

08035

Hospital Universitari Vall d Hebron, Barcelona

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

08908

Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals, L'Hospitalet de Llobregat

W1G 6AD

Sarah Cannon Research Institute UK, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY