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

Primary Purpose

Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Sotorasib
trametinib
RMC-4630
afatinib
pembrolizumab
panitumumab
carboplatin, pemetrexed, docetaxel, paclitaxel
atezolizumab
palbociclib
MVASI® (bevacizumab-awwb)
TNO155
FOLFIRI
FOLFOX
BI 1701963
AMG 404
everolimus
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Exclusion Criteria:

  • Primary brain tumor.
  • Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
  • Myocardial infarction within 6 months of study day 1.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Sites / Locations

  • Arizona Oncology Associates Professional CorporationRecruiting
  • City of Hope National Medical CenterRecruiting
  • University of California San Diego Moores Cancer Center
  • Loma Linda University Cancer CenterRecruiting
  • University of Southern California, Norris Comprehensive Cancer CenterRecruiting
  • University of California Davis Medical CenterRecruiting
  • University of California at SFRecruiting
  • University of California Los AngelesRecruiting
  • Rocky Mountain Cancer Centers Denver MidtownRecruiting
  • Sarah Cannon Research Institute at HealthONERecruiting
  • Yale Cancer CenterRecruiting
  • Norwalk HospitalRecruiting
  • Memorial Cancer InstituteRecruiting
  • Moffitt Cancer CenterRecruiting
  • Emory UniversityRecruiting
  • Northwestern UniversityRecruiting
  • University of Chicago Medical CenterRecruiting
  • Indiana UniversityRecruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterRecruiting
  • University of MichiganRecruiting
  • Henry Ford Health SystemRecruiting
  • Washington UniversityRecruiting
  • Montefiore Medical Center
  • Roswell Park Cancer InstituteRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Columbia University Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Levine Cancer InstituteRecruiting
  • Duke University Medical CenterRecruiting
  • University of Cincinnati Medical CenterRecruiting
  • Cleveland Clinic
  • Providence Portland Medical CenterRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Thomas Jefferson UniversityRecruiting
  • Fox Chase Cancer Center
  • University of PennsylvaniaRecruiting
  • University of Pittsburgh Medical Center Cancer PavillionRecruiting
  • Gibbs Cancer Center and Research Institute - SpartanburgRecruiting
  • Avera Cancer Institute
  • Henry Joyce Cancer CenterRecruiting
  • Texas Oncology - Austin MidtownRecruiting
  • Mary Crowley Cancer ResearchRecruiting
  • University of Texas Southwestern Medical CenterRecruiting
  • Oncology ConsultantsRecruiting
  • University of Texas MD Anderson Cancer CenterRecruiting
  • United States Oncology Regulatory Affairs Corporate OfficeRecruiting
  • US Oncology Research Investigational Products CenterRecruiting
  • Texas Oncology-TylerRecruiting
  • Huntsman Cancer InstituteRecruiting
  • University of VirginiaRecruiting
  • Virginia Cancer Specialists, PCRecruiting
  • Fred Hutchinson Cancer CenterRecruiting
  • Northwest Medical Specialties, PLLCRecruiting
  • Northwest Cancer Specialists - VancouverRecruiting
  • Nepean Cancer CentreRecruiting
  • GenesisCare -North Shore OncologyRecruiting
  • Icon Cancer Care South BrisbaneRecruiting
  • The Queen Elizabeth HospitalRecruiting
  • St John of God HealthcareRecruiting
  • Medizinische Universitaet GrazRecruiting
  • Universitaetsklinikum SalzburgRecruiting
  • Universite Catholique de Louvain Cliniques Universitaires Saint LucRecruiting
  • Universitair Ziekenhuis AntwerpenRecruiting
  • CHU de Quebec Hopital de l Enfant JesusRecruiting
  • Charite Universitaetsmedizin Berlin, Campus VirchowRecruiting
  • Universitaetsklinikum Carl Gustav CarusRecruiting
  • Universitaetsklinikum EssenRecruiting
  • Universitatsklinikum KolnRecruiting
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting
  • Azienda Ospedaliera Universitaria Pisana Ospedale Santa ChiaraRecruiting
  • Centro Ricerche ClinicheRecruiting
  • Aichi Cancer CenterRecruiting
  • National Cancer Center Hospital EastRecruiting
  • The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchRecruiting
  • Seoul National University HospitalRecruiting
  • The Catholic University of Korea Seoul St Marys HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Universitair Medisch Centrum UtrechtRecruiting
  • Hospital Universitari Vall d HebronRecruiting
  • Hospital Clinic i Provincial de BarcelonaRecruiting
  • Institut Catala d Oncologia Hospitalet Hospital Duran i ReynalsRecruiting
  • Hospital Universitario Puerta de Hierro MajadahondaRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical FoundationRecruiting
  • Sarah Cannon Research Institute UKRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sotorasib + trametinib + panitumumab

Sotorasib + RMC-4630

Sotorasib + afatinib

Sotorasib + panitumumab +/- FOLFIRI

Sotorasib + atezolizumab

Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab

Sotorasib Monotherapy

Sotorasib + palbociclib

Sotorasib + pembrolizumab

Sotorasib + MVASI® (bevacizumab-awwb)+ FOLFIRI or FOLFOX

Sotorasib + TNO155

Sotorasib + BI 1701963

Sotorasib + AMG 404

Sotorasib + everolimus

Arm Description

Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Experimental: Sotorasib + panitumumab +/- FOLFIRI Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Experimental: Sotorasib only Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.

Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.

Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant non small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant non small cell lung cancer.

Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ FOLFIRI or FOLFOX Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.

Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.

Experimental: Sotorasib + AMG 404 Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors

Experimental: Sotorasib + everolimus Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.

Outcomes

Primary Outcome Measures

Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs)
Phase 1b: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Phase 1b: Number of Participants with Treatment-related Adverse Events
Phase 1b: Number of Participants with Clinically Significant Changes in Vital Signs
Phase 1b: Number of Participants with Clinically Significant Changes in ECG Measurements
Phase 1b: Number of Participants with Clinically Significant Changes in Laboratory Test Values
Phase 2: Objective Response Rate

Secondary Outcome Measures

Phase 1b: Maximum Plasma Concentration (Cmax)
Phase 1b: Time to Maximum Plasma Concentration (Tmax)
Phase 1b: Area Under the Plasma Concentration-time Curve (AUC)
Phase 1b: Objective Response Rate
Phase 1b: Disease Control Rate
Phase 1b: Duration of Response
Phase 1b: Progression-free Survival
Phase 1b: Duration of Stable Disease
Phase 1b: Time to Response
Phase 1b: Overall Survival
Phase 1b: Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels
Phase 1b: Sotorasib Monotherapy Only: Intracranial Objective Response Rate
Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Phase 1b: Sotorasib Monotherapy Only: Intracranial Disease Control Rate
Intracranial disease control rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Phase 1b: Sotorasib Monotherapy Only: Intracranial Duration of Response
Intracranial duration of response assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Phase 1b: Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy
Phase 1b: Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS)
Intracranial PFS assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM)
Phase 1b: Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS)
Non-intracranial PFS assessed per RECIST 1.1.
Phase 1b: Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS)
Overall PFS assessed per RECIST 1.1 and RANO-BM.
Phase 1b: Sotorasib + TNO155 Only: Best Overall Response
Phase 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Phase 2: Number of Participants with Grade ≥3 Treatment-emergent Adverse Events (TEAEs)
Phase 2: Maximum Plasma Concentration (Cmax)
Phase 2: Time to Maximum Plasma Concentration (Tmax)
Phase 2: Area Under the Plasma Concentration-time Curve (AUC)
Phase 2: Disease Control Rate
Phase 2: Duration of Response
Phase 2: Progression-free Survival
Phase 2: Time to Response
Phase 2: Overall Survival
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs)
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values

Full Information

First Posted
December 3, 2019
Last Updated
October 2, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04185883
Brief Title
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Official Title
A Phase 1b/2, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
May 22, 2026 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1143 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sotorasib + trametinib + panitumumab
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
Arm Title
Sotorasib + RMC-4630
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.
Arm Title
Sotorasib + afatinib
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
Arm Title
Sotorasib + panitumumab +/- FOLFIRI
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + panitumumab +/- FOLFIRI Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
Arm Title
Sotorasib + atezolizumab
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
Arm Title
Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
Arm Title
Sotorasib Monotherapy
Arm Type
Experimental
Arm Description
Experimental: Sotorasib only Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.
Arm Title
Sotorasib + palbociclib
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.
Arm Title
Sotorasib + pembrolizumab
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant non small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant non small cell lung cancer.
Arm Title
Sotorasib + MVASI® (bevacizumab-awwb)+ FOLFIRI or FOLFOX
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ FOLFIRI or FOLFOX Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.
Arm Title
Sotorasib + TNO155
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
Arm Title
Sotorasib + BI 1701963
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.
Arm Title
Sotorasib + AMG 404
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + AMG 404 Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors
Arm Title
Sotorasib + everolimus
Arm Type
Experimental
Arm Description
Experimental: Sotorasib + everolimus Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.
Intervention Type
Drug
Intervention Name(s)
Sotorasib
Intervention Description
Sotorasib administered orally as a tablet.
Intervention Type
Drug
Intervention Name(s)
trametinib
Intervention Description
trametinib administered orally as a tablet.
Intervention Type
Drug
Intervention Name(s)
RMC-4630
Intervention Description
RMC-4630 administered orally as a capsule.
Intervention Type
Drug
Intervention Name(s)
afatinib
Intervention Description
afatinib administered orally as a tablet.
Intervention Type
Drug
Intervention Name(s)
pembrolizumab
Intervention Description
pembrolizumab administered as an intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
panitumumab
Intervention Description
panitumumab administered as an intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
carboplatin, pemetrexed, docetaxel, paclitaxel
Intervention Description
carboplatin, pemetrexed, docetaxel administered as an intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
atezolizumab
Intervention Description
atezolizumab administered as an intravenous (IV) injection.
Intervention Type
Drug
Intervention Name(s)
palbociclib
Intervention Description
palbociclib administered orally as a tablet.
Intervention Type
Drug
Intervention Name(s)
MVASI® (bevacizumab-awwb)
Intervention Description
MVASI® (bevacizumab-awwb) administered as an intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
TNO155
Intervention Description
TNO155 administered orally as a capsule.
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
FOLFIRI chemotherapy combination of leucovorin administered as an intravenous (IV) injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Intervention Description
FOLFOX chemotherapy combination of leucovorin administered as intravenous (IV) injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.
Intervention Type
Drug
Intervention Name(s)
BI 1701963
Intervention Description
BI 1701963 administered orally
Intervention Type
Drug
Intervention Name(s)
AMG 404
Intervention Description
AMG 404 administered as an intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
everolimus
Intervention Description
everolimus administered orally.
Primary Outcome Measure Information:
Title
Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame
12 Months
Title
Phase 1b: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame
12 Months
Title
Phase 1b: Number of Participants with Treatment-related Adverse Events
Time Frame
12 Months
Title
Phase 1b: Number of Participants with Clinically Significant Changes in Vital Signs
Time Frame
12 Months
Title
Phase 1b: Number of Participants with Clinically Significant Changes in ECG Measurements
Time Frame
12 Months
Title
Phase 1b: Number of Participants with Clinically Significant Changes in Laboratory Test Values
Time Frame
12 Months
Title
Phase 2: Objective Response Rate
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Phase 1b: Maximum Plasma Concentration (Cmax)
Time Frame
12 Months
Title
Phase 1b: Time to Maximum Plasma Concentration (Tmax)
Time Frame
12 Months
Title
Phase 1b: Area Under the Plasma Concentration-time Curve (AUC)
Time Frame
12 Months
Title
Phase 1b: Objective Response Rate
Time Frame
12 Months
Title
Phase 1b: Disease Control Rate
Time Frame
12 Months
Title
Phase 1b: Duration of Response
Time Frame
12 Months
Title
Phase 1b: Progression-free Survival
Time Frame
12 Months
Title
Phase 1b: Duration of Stable Disease
Time Frame
12 Months
Title
Phase 1b: Time to Response
Time Frame
12 Months
Title
Phase 1b: Overall Survival
Time Frame
12 Months
Title
Phase 1b: Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels
Time Frame
12 Months
Title
Phase 1b: Sotorasib Monotherapy Only: Intracranial Objective Response Rate
Description
Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Time Frame
12 Months
Title
Phase 1b: Sotorasib Monotherapy Only: Intracranial Disease Control Rate
Description
Intracranial disease control rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Time Frame
12 Months
Title
Phase 1b: Sotorasib Monotherapy Only: Intracranial Duration of Response
Description
Intracranial duration of response assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Time Frame
12 Months
Title
Phase 1b: Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy
Time Frame
12 Months
Title
Phase 1b: Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS)
Description
Intracranial PFS assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM)
Time Frame
12 Months
Title
Phase 1b: Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS)
Description
Non-intracranial PFS assessed per RECIST 1.1.
Time Frame
12 Months
Title
Phase 1b: Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS)
Description
Overall PFS assessed per RECIST 1.1 and RANO-BM.
Time Frame
12 Months
Title
Phase 1b: Sotorasib + TNO155 Only: Best Overall Response
Time Frame
12 Months
Title
Phase 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame
12 Months
Title
Phase 2: Number of Participants with Grade ≥3 Treatment-emergent Adverse Events (TEAEs)
Time Frame
12 Months
Title
Phase 2: Maximum Plasma Concentration (Cmax)
Time Frame
12 Months
Title
Phase 2: Time to Maximum Plasma Concentration (Tmax)
Time Frame
12 Months
Title
Phase 2: Area Under the Plasma Concentration-time Curve (AUC)
Time Frame
12 Months
Title
Phase 2: Disease Control Rate
Time Frame
12 Months
Title
Phase 2: Duration of Response
Time Frame
12 Months
Title
Phase 2: Progression-free Survival
Time Frame
12 Months
Title
Phase 2: Time to Response
Time Frame
12 Months
Title
Phase 2: Overall Survival
Time Frame
12 Months
Title
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame
12 Months
Title
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame
12 Months
Title
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events
Time Frame
12 Months
Title
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs
Time Frame
12 Months
Title
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements
Time Frame
12 Months
Title
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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 performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Exclusion Criteria: Primary brain tumor. Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors. Myocardial infarction within 6 months of study day 1. Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates Professional Corporation
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Terminated
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Southern California, Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California at SF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Los Angeles
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Cancer Centers Denver Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute at HealthONE
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Cancer Institute
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5912
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Terminated
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Terminated
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Terminated
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center Cancer Pavillion
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Gibbs Cancer Center and Research Institute - Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Terminated
Facility Name
Henry Joyce Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
United States Oncology Regulatory Affairs Corporate Office
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Name
US Oncology Research Investigational Products Center
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology-Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Cancer Specialists - Vancouver
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Individual Site Status
Recruiting
Facility Name
Nepean Cancer Centre
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Individual Site Status
Recruiting
Facility Name
GenesisCare -North Shore Oncology
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Icon Cancer Care South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Individual Site Status
Recruiting
Facility Name
St John of God Healthcare
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Quebec Hopital de l Enfant Jesus
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Charite Universitaetsmedizin Berlin, Campus Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Koln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Centro Ricerche Cliniche
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aichi Cancer Center
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St Marys Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d Hebron
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
City
Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute UK
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing 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 (or other new use) 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.
IPD Sharing 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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