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Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (CodeBreak 300)

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ClinicalTrials.gov Identifier: NCT05198934
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).

Condition or disease Intervention/treatment Phase
Colorectal Cancer (CRC) Drug: Sotorasib Drug: Panitumumab Drug: Trifluridine and Tipiracil Drug: Regorafenib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : January 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Sotorasib 960 mg once daily (QD) + panitumumab Drug: Sotorasib
Sotorasib will be administered orally
Other Name: AMG 510, Lumakras, Lumykras

Drug: Panitumumab
Panitumumab will be administered as intravenous (IV) infusion
Other Name: Vectibix
Experimental: Arm B: Sotorasib 240 mg once daily (QD) + panitumumab Drug: Sotorasib
Sotorasib will be administered orally
Other Name: AMG 510, Lumakras, Lumykras

Drug: Panitumumab
Panitumumab will be administered as intravenous (IV) infusion
Other Name: Vectibix
Active Comparator: Arm C : Investigator's choice
Participants will be administered trifluridine and tipiracil, or regorafenib
 Drug: Trifluridine and Tipiracil
Trifluridine and Tipiracil will be administered orally
Other Name: Lonsurf

Drug: Regorafenib
Regorafenib will be administered orally
Other Name: Stivarga


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Approximately 2 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 2 years ]
  2. Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
  3. Duration of Response (DOR) [ Time Frame: Approximately 2 years ]
  4. Time to Response (TTR) [ Time Frame: Approximately 2 years ]
  5. Disease Control Rate (DCR) [ Time Frame: Approximately 2 years ]
  6. Investigator Assessed Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
  7. Investigator Assessed Progression-free Survival (PFS) [ Time Frame: Approximately 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
  • Age ≥18 years.
  • Pathologically documented metastatic colorectal adenocarcinoma with Kirsten rat sarcoma (KRAS) p.G12C mutation as determined by central testing.
  • Participants will have received at least 1 prior line of therapy for metastatic disease. Participants must have received and progressed or experienced disease recurrence on or after fluoropyrimidine, irinotecan, and oxaliplatin given for metastatic disease unless the participant, in the opinion of the investigator, is not a candidate for fluoropyrimidine, irinotecan, or oxaliplatin, in which case, the participant may be eligible after investigator discussion with Amgen medical monitor provided participant has received at least one prior line of therapy for metastatic disease and provided trifluridine and tipiracil or regorafenib is deemed the appropriate next line of therapy for the participant.
  • Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. Lesions previously radiated are not considered measurable unless they have progressed after radiation.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
  • Life expectancy of >3 months, in the opinion of the investigator.

  • Adequate hematologic and end-organ function, defined as the following within 10 days prior to randomization:

    • Absolute neutrophil count (ANC) ≥1.5 x 10^9/L (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility).
    • Hemoglobin ≥9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility).
    • Platelet count ≥100 x 10^9/L (without transfusion within 2 weeks of laboratory test used to determine eligibility).
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal (ULN).
    • Serum bilirubin ≤1.0 x ULN. For participants with Gilbert's disease, direct bilirubin ≤1.0 x ULN.
    • International normalized ratio (INR) and activated partial thromboplastin time (or partial thromboplastin time) ≤1.5 x ULN. Prothrombin time (PT) ≤1.5 x ULN may be used instead of INR for sites whose labs do not report INR.
    • Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥30 mL/min/1.73 m^2.
  • Fridericia's Correction Formula (QTcF) ≤470 msec.

Exclusion Criteria:

  • Active brain metastases. Participants who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible if they meet all of the following criteria: a) residual neurological symptoms grade ≤2; b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and c) follow-up magnetic resonance imaging (MRI) performed within 28 days of day 1 shows no progression or new lesions appearing.
  • History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥2 years.

  • History of other malignancy within the past 3 years, with the following exceptions:

    • Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated cervical carcinoma in situ without evidence of disease.
    • Adequately treated breast ductal carcinoma in situ without evidence of disease.
    • Prostatic intraepithelial neoplasia without evidence of prostate cancer.
    • Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ.
  • Leptomeningeal disease.
  • Significant gastrointestinal (GI) disorder that results in significant malabsorption, requirement for intravenous (IV) alimentation, or inability to take oral medication.
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months prior to randomization, unstable arrhythmias or unstable angina.
  • Previous treatment with a KRAS G12C inhibitor.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05198934


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05198934    
Other Study ID Numbers: 20190172
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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 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.
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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Sotorasib
AMG 510
Panitumumab
Metastatic colorectal cancer
Kirsten rat sarcoma p.G12C mutation
Additional relevant MeSH terms:
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Colorectal Neoplasms
Sarcoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Trifluridine
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents