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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04185883
Registration number
NCT04185883
Ethics application status
Date submitted
3/12/2019
Date registered
4/12/2019
Date last updated
6/06/2024
Titles & IDs
Public title
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
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Scientific title
A Phase 1b, 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)
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Secondary ID [1]
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2023-506794-35
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Secondary ID [2]
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20190135
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Kirsten Rat Sarcoma (KRAS) pG12C Mutation
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Condition category
Condition code
Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Sotorasib
Treatment: Drugs - Trametinib
Treatment: Drugs - RMC-4630
Treatment: Drugs - Afatinib
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Panitumumab
Treatment: Drugs - Carboplatin, pemetrexed, docetaxel, paclitaxel
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Palbociclib
Treatment: Drugs - MVASI® (bevacizumab-awwb)
Treatment: Drugs - TNO155
Treatment: Drugs - IV Chemotherapy (Regimen 1)
Treatment: Drugs - IV Chemotherapy (Regimen 2)
Treatment: Drugs - BI 1701963
Treatment: Drugs - AMG 404
Treatment: Drugs - Everolimus
Experimental: Sotorasib + trametinib + panitumumab - 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 - 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 - 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 +/- chemotherapy - Experimental: Sotorasib + panitumumab +/- chemotherapy 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 - 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 - 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 Monotherapy - 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 - 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 - 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)+ Chemotherapy - Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ chemotherapy 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 - 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 - 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 - 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 - 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.
Treatment: Drugs: Sotorasib
Sotorasib administered orally as a tablet.
Treatment: Drugs: Trametinib
Trametinib administered orally as a tablet.
Treatment: Drugs: RMC-4630
RMC-4630 administered orally as a capsule.
Treatment: Drugs: Afatinib
afatinib administered orally as a tablet.
Treatment: Drugs: Pembrolizumab
pembrolizumab administered as an intravenous (IV) infusion.
Treatment: Drugs: Panitumumab
Panitumumab administered as an IV infusion.
Treatment: Drugs: Carboplatin, pemetrexed, docetaxel, paclitaxel
Carboplatin, pemetrexed, docetaxel administered as an IV infusion.
Treatment: Drugs: Atezolizumab
Atezolizumab administered as an IV injection.
Treatment: Drugs: Palbociclib
Palbociclib administered orally as a tablet.
Treatment: Drugs: MVASI® (bevacizumab-awwb)
MVASI® (bevacizumab-awwb) administered as an IV infusion.
Treatment: Drugs: TNO155
TNO155 administered orally as a capsule.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: BI 1701963
BI 1701963 administered orally
Treatment: Drugs: AMG 404
AMG 404 administered as an IV infusion.
Treatment: Drugs: Everolimus
Everolimus administered orally.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Dose Limiting Toxicities (DLTs)
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12 Months
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Primary outcome [2]
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Number of Participants with Treatment-emergent Adverse Events (TEAEs)
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12 Months
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Primary outcome [3]
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Number of Participants with Treatment-related Adverse Events
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Assessment method [3]
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12 Months
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Primary outcome [4]
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Number of Participants with Clinically Significant Changes in Vital Signs
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12 Months
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Primary outcome [5]
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Number of Participants with Clinically Significant Changes in ECG Measurements
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Assessment method [5]
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12 Months
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Primary outcome [6]
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Number of Participants with Clinically Significant Changes in Laboratory Test Values
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12 Months
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Secondary outcome [1]
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Maximum Plasma Concentration (Cmax)
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12 Months
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Time to Maximum Plasma Concentration (Tmax)
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Area Under the Plasma Concentration-time Curve (AUC)
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12 Months
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Secondary outcome [4]
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Objective Response Rate
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12 Months
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Disease Control Rate
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12 Months
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Duration of Response
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12 Months
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Secondary outcome [7]
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Progression-free Survival
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Secondary outcome [8]
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Duration of Stable Disease
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Secondary outcome [9]
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Time to Response
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12 Months
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Overall Survival
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12 Months
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Secondary outcome [11]
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Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels
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12 Months
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Secondary outcome [12]
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Sotorasib Monotherapy Only: Intracranial Objective Response Rate
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Assessment method [12]
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Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
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12 Months
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Secondary outcome [13]
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Sotorasib Monotherapy Only: Intracranial Disease Control Rate
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Intracranial disease control rate assessed per RANO-BM.
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12 Months
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Sotorasib Monotherapy Only: Intracranial Duration of Response
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Intracranial duration of response assessed per RANO-BM.
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12 Months
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Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy
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12 Months
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Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS)
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Intracranial PFS assessed per RANO-BM.
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Timepoint [16]
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12 Months
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Secondary outcome [17]
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Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS)
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Assessment method [17]
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Non-intracranial PFS assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
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Timepoint [17]
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12 Months
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Secondary outcome [18]
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Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS)
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Overall PFS assessed per RECIST 1.1 and RANO-BM.
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12 Months
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Secondary outcome [19]
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Sotorasib + TNO155 Only: Best Overall Response
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12 Months
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Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs)
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12 Months
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Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
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12 Months
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Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events
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12 Months
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Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs
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12 Months
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Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements
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12 Months
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Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values
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Timepoint [25]
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12 Months
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Eligibility
Key inclusion criteria
- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.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.
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2027
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Actual
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Sample size
Target
1200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Nepean Cancer Centre - Kingswood
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Recruitment hospital [2]
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GenesisCare -North Shore Oncology - St Leonards
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Icon Cancer Care South Brisbane - South Brisbane
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The Queen Elizabeth Hospital - Woodville South
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St John of God Healthcare - Subiaco
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Recruitment postcode(s) [1]
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2747 - Kingswood
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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5011 - Woodville South
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Recruitment postcode(s) [5]
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6008 - Subiaco
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Maryland
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Michigan
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New York
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North Carolina
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South Carolina
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South Dakota
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Washington
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Austria
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Graz
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Austria
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Salzburg
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Belgium
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Edegem
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Koeln
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Chiba
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Tokyo
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Seoul
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Utrecht
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Cataluña
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Madrid
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Tainan
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Taipei
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Taoyuan
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04185883
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Trial related presentations / publications
Kuboki Y, Fakih M, Strickler J, Yaeger R, Masuishi T, Kim EJ, Bestvina CM, Kopetz S, Falchook GS, Langer C, Krauss J, Puri S, Cardona P, Chan E, Varrieur T, Mukundan L, Anderson A, Tran Q, Hong DS. Sotorasib with panitumumab in chemotherapy-refractory KRASG12C-mutated colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):265-270. doi: 10.1038/s41591-023-02717-6. Epub 2024 Jan 4.
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Amgen Call Center
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866-572-6436
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[email protected]
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04185883
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