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Recruitment Complete
Sponsor ID
20190135

Sotorasib activity in Subjects with Advanced Solid Tumors with KRAS p.G12C Mutation (CodeBreak 101)

Sponsor ID
20190135
Clinicaltrials.gov ID
NCT04185883
EUCTIS ID
2023-506794-35
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 1
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
610
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: 12 Months

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: 12 Months

Number of Participants with Treatment-related Adverse Events

Timeframe: 12 Months

Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: 12 Months

Number of Participants with Clinically Significant Changes in ECG Measurements

Timeframe: 12 Months

Number of Participants with Clinically Significant Changes in Laboratory Test Values

Timeframe: 12 Months

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax)

Timeframe: 12 Months

Time to Maximum Plasma Concentration (Tmax)

Timeframe: 12 Months

Area Under the Plasma Concentration-time Curve (AUC)

Timeframe: 12 Months

Objective Response Rate

Timeframe: 12 Months

Disease Control Rate

Timeframe: 12 Months

Duration of Response

Timeframe: 12 Months

Progression-free Survival

Timeframe: 12 Months

Duration of Stable Disease

Timeframe: 12 Months

Time to Response

Timeframe: 12 Months

Overall Survival

Timeframe: 12 Months

Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels

Timeframe: 12 Months

Sotorasib Monotherapy Only: Intracranial Objective Response Rate

Timeframe: 12 Months

Sotorasib Monotherapy Only: Intracranial Disease Control Rate

Timeframe: 12 Months

Sotorasib Monotherapy Only: Intracranial Duration of Response

Timeframe: 12 Months

Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy

Timeframe: 12 Months

Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS)

Timeframe: 12 Months

Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS)

Timeframe: 12 Months

Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS)

Timeframe: 12 Months

Sotorasib + TNO155 Only: Best Overall Response

Timeframe: 12 Months

Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: 12 Months

Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: 12 Months

Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events

Timeframe: 12 Months

Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: 12 Months

Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements

Timeframe: 12 Months

Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values

Timeframe: 12 Months

Locations

Location
Status
Contact Us
Location
University of Texas MD Anderson Cancer Center
Houston, TX, United States, 77030
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
Duke University
Durham, NC, United States, 27710
Status
Recruiting
Location
Washington University
St. Louis, MO, United States, 63110-1093
Status
Recruiting
Location
Memorial Sloan Kettering Cancer Center
New York, NY, United States, 10065
Status
Recruiting
Location
University of California Davis Medical Center
Sacramento, CA, United States, 95817
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 100 Years
Condition
  • Solid Tumor
    • Show more
  • KRAS G12 Mutation
    • Sex
    All
    Trial Dates
    Dec 2019 - Dec 2026
    Inclusion and Exclusion 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.