SOTORASIB for Metastatic colorectal cancer | Colorectal cancer

Inclusion criteria

• {"criterion_text":"- Pathologically documented metastatic colorectal adenocarcinoma\n- Central confirmation of KRAS p.G12C mutation\n- Measurable disease per RECIST v1.1 criteria. Lesions previously radiated are not considered measurable unless they have progressed after radiation\n- Age ≥ 18 years (or ≥ legal age within the country if it is more than 18 years)\n- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1\n- Life expectancy of > 6 months, in the opinion of the investigator\n- Adequate hematologic and end organ function\n- Ability to take oral medications and willing to record daily adherence to investigational product\n- Central laboratory detection of KRAS p.G12C mutation"}

Exclusion criteria

• {"criterion_text":"- Active, untreated brain metastases\n- Leptomeningeal disease\n- Previous treatment with a KRAS p.G12C inhibitor\n- Subject has required a dose reduction or dose delay of either 5-fluorouracil (5-FU) or irinotecan in any prior chemotherapy regimen in the past for toxicity, to the investigator's knowledge\n- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan"}

Primary endpoints

• {"endpoint_text":"- PFS, defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression will be based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).","definition_or_measurement_approach":"PFS defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression based on blinded independent central review (BICR) of disease response per RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- OS, defined as time from randomization until death from any cause","definition_or_measurement_approach":"OS = time from randomization until death from any cause."}
• {"endpoint_text":"- Objective response rate (ORR), defined as proportion of complete response (CR) + partial response (PR), assessed per RECIST v1.1 by BICR. CR and PR require confirmatory repeat assessment at least 4 weeks after the first detection of response.","definition_or_measurement_approach":"ORR = proportion CR + PR assessed per RECIST v1.1 by blinded independent central review (BICR); CR and PR require confirmatory repeat assessment ≥4 weeks after first detection."}
• {"endpoint_text":"- Duration of response (DOR) per RECIST v1.1 by BICR, defined as the time from the first documentation of objective response until the first documentation of disease progression or death from any cause, whichever occurs first.","definition_or_measurement_approach":"DOR defined as time from first documentation of objective response until first documentation of progression or death, per RECIST v1.1 by BICR."}
• {"endpoint_text":"- Disease control rate (DCR), defined as proportion of CR + PR + stable disease (SD) per RECIST v1.1 by BICR. Minimum time interval for determination of SD is 7 weeks from randomization date","definition_or_measurement_approach":"DCR = proportion CR + PR + SD per RECIST v1.1 by BICR. Minimum interval to determine SD is 7 weeks from randomization."}
• {"endpoint_text":"- Time to response (TTR), defined as the time from randomization to first documentation of objective response per RECIST v1.1 by BICR.","definition_or_measurement_approach":"TTR = time from randomization to first documentation of objective response per RECIST v1.1 by BICR."}
• {"endpoint_text":"- Depth of response per RECIST v1.1 by BICR, defined as best percent change from baseline in sum of lesion diameters.","definition_or_measurement_approach":"Depth of response = best percent change from baseline in sum of lesion diameters per RECIST v1.1 by BICR."}
• {"endpoint_text":"- Early tumor shrinkage (ETS) by BICR, defined as achieving at least 30% reduction in tumor size at first post-baseline assessment (at least 7 weeks from randomization date).","definition_or_measurement_approach":"ETS = ≥30% reduction in tumor size at first post-baseline assessment (≥7 weeks from randomization) assessed by BICR."}
• {"endpoint_text":"- PFS, ORR, DOR, DCR, TTR, depth of response and ETS based on investigator’s assessment per RECIST v1.1, if applicable.","definition_or_measurement_approach":"Investigator-assessed versions of PFS, ORR, DOR, DCR, TTR, depth of response and ETS per RECIST v1.1, where applicable."}
• {"endpoint_text":"- Incidence and severity of treatment-emergent adverse events, changes in vital signs, and changes in clinical laboratory tests.","definition_or_measurement_approach":"Safety endpoints include incidence and severity of treatment-emergent adverse events, changes in vital signs, and clinical laboratory test changes (standard AE reporting)."}
• {"endpoint_text":"- PK parameters of sotorasib including, but not limited to, maximum plasma concentration (Cmax) and pre-dose (Ctrough) concentrations, as applicable.","definition_or_measurement_approach":"PK endpoints for sotorasib include parameters such as Cmax and pre-dose (Ctrough) concentrations as applicable."}

Methods

• Physician referral via physician referral letter and email templates (documents: 'K2_Recruitment material Physician Referral Letter Email Template' and equivalents) targeting treating physicians/clinics.
• Patient-facing materials including patient brochures and study brochures (documents: 'K2_Recruitment material_Patients Brochure', country-specific brochures) to inform potential participants.
• Centralized patient recruitment support (third-party patient recruitment vendor listed: Reify Health Inc. / Reify Health Inc. duties: 'Patient Recruitment').
• Use of centralized biomarker testing partners to identify eligible subjects (e.g. Tempus AI Inc., Guardant Health Inc.) as part of screening and recruitment workflow.

France

Earliest CTIS Part Ii Submission Date

2024-05-13

Latest Decision Or Authorization Date

2024-08-05

Number Of Participants

30

Sweden

Earliest CTIS Part Ii Submission Date

2024-07-05

Latest Decision Or Authorization Date

2024-08-01

Number Of Participants

2

Italy

Earliest CTIS Part Ii Submission Date

2024-07-10

Latest Decision Or Authorization Date

2024-07-31

Number Of Participants

48

Bulgaria

Earliest CTIS Part Ii Submission Date

2024-07-08

Latest Decision Or Authorization Date

2024-07-30

Number Of Participants

10

Slovakia

Earliest CTIS Part Ii Submission Date

2025-05-05

Latest Decision Or Authorization Date

2025-05-29

Number Of Participants

2

Spain

Earliest CTIS Part Ii Submission Date

2024-07-19

Latest Decision Or Authorization Date

2024-08-01

Number Of Participants

32

Denmark

Earliest CTIS Part Ii Submission Date

2024-07-08

Latest Decision Or Authorization Date

2024-07-29

Number Of Participants

4

Austria

Earliest CTIS Part Ii Submission Date

2024-06-24

Latest Decision Or Authorization Date

2024-08-05

Number Of Participants

7

Estonia

Earliest CTIS Part Ii Submission Date

2024-07-10

Latest Decision Or Authorization Date

2024-08-02

Number Of Participants

3

Germany

Earliest CTIS Part Ii Submission Date

2024-06-21

Latest Decision Or Authorization Date

2024-07-29

Number Of Participants

13

Netherlands

Earliest CTIS Part Ii Submission Date

2024-07-16

Latest Decision Or Authorization Date

2024-07-31

Number Of Participants

11

Hungary

Earliest CTIS Part Ii Submission Date

2024-07-12

Latest Decision Or Authorization Date

2024-08-02

Number Of Participants

7

Portugal

Earliest CTIS Part Ii Submission Date

2024-07-08

Latest Decision Or Authorization Date

2024-07-30

Number Of Participants

14

Romania

Earliest CTIS Part Ii Submission Date

2024-07-01

Latest Decision Or Authorization Date

2024-08-05

Number Of Participants

9

Belgium

Earliest CTIS Part Ii Submission Date

2024-07-02

Latest Decision Or Authorization Date

2024-07-30

Number Of Participants

15

Poland

Earliest CTIS Part Ii Submission Date

2024-07-17

Latest Decision Or Authorization Date

2024-08-04

Number Of Participants

9

Czechia

Earliest CTIS Part Ii Submission Date

2024-07-01

Latest Decision Or Authorization Date

2024-08-01

Number Of Participants

10

Slovakia (MSC added later)

Earliest CTIS Part Ii Submission Date

2025-05-05

Latest Decision Or Authorization Date

2025-05-29

Number Of Participants

2

Primary sponsor

Full Name

Amgen Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Excelya Greece CRO Single Member S.A.

Name

Altasciences Compagnie Inc.

Responsibilities

PK testing

Name

WCG Clinical Inc.

Responsibilities

Data Monitoring Committee

Name

Labcorp Central Laboratory Services LP / SARL

Responsibilities

Central laboratory services

Third parties

• {"country":"United States","full_name":"Tempus AI Inc.","duties_or_roles":"Biomarker testing","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Data Monitoring Committee","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"PK testing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Avantor Performance Materials Inc.","duties_or_roles":"Equipment Provisioning","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"Patient Recruitment","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Samples will be stored","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Tempus AI Inc.","duties_or_roles":"Biomarker testing","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"special materials (e.g. ctDNA) will be analyzed for the study","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Altasciences Compagnie Inc. (Canada)","duties_or_roles":"PK testing","organisation_type":"Pharmaceutical company"}