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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05198934
Registration number
NCT05198934
Ethics application status
Date submitted
6/01/2022
Date registered
20/01/2022
Titles & IDs
Public title
Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
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Scientific 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
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Secondary ID [1]
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20190172
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Universal Trial Number (UTN)
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Trial acronym
CodeBreak300
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer (CRC)
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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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
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Description of intervention(s) / exposure
Treatment: Drugs - Sotorasib
Treatment: Drugs - Panitumumab
Treatment: Drugs - Trifluridine and Tipiracil
Treatment: Drugs - Regorafenib
Experimental: Arm A: Sotorasib 960 mg QD + panitumumab -
Experimental: Arm B: Sotorasib 240 mg QD + panitumumab -
Active comparator: Arm C : Investigator's choice - Participants will be administered trifluridine and tipiracil, or regorafenib
Treatment: Drugs: Sotorasib
Sotorasib will be administered orally
Treatment: Drugs: Panitumumab
Panitumumab will be administered as intravenous (IV) infusion
Treatment: Drugs: Trifluridine and Tipiracil
Trifluridine and Tipiracil will be administered orally
Treatment: Drugs: Regorafenib
Regorafenib will be 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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Progression-free Survival (PFS)
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Assessment method [1]
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Timepoint [1]
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Approximately 3 years
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Timepoint [1]
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Approximately 3 years
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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Timepoint [2]
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Approximately 3 years
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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Timepoint [3]
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Approximately 3 years
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Secondary outcome [4]
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Time to Response (TTR)
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Assessment method [4]
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Timepoint [4]
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Approximately 3 years
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Secondary outcome [5]
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Disease Control Rate (DCR)
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Assessment method [5]
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Timepoint [5]
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Approximately 3 years
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Secondary outcome [6]
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Investigator Assessed ORR
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Assessment method [6]
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Timepoint [6]
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Approximately 3 years
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Secondary outcome [7]
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Investigator Assessed PFS
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Assessment method [7]
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Timepoint [7]
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Approximately 3 years
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Secondary outcome [8]
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Number of Participants with a Treatment-emergent Adverse Event (TEAE)
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Assessment method [8]
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A TEAE is any untoward medical occurrence in a clinical study participant following first dose of treatment irrespective of a causal relationship with the study treatment. Any clinically significant changes in vital signs and clinical laboratory tests following first dose will be recorded as TEAEs.
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Timepoint [8]
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Approximately 3 years
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Secondary outcome [9]
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Change from Baseline in Fatigue Severity as Measured by Item 3 of the Brief Fatigue Inventory (BFI)
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Assessment method [9]
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Item 3 of the BFI records a participants' fatigue on a scale from 0 to 10. Higher scores indicate a higher severity of fatigue. An increase in score from baseline indicates a worsening of fatigue. A decrease in score from baseline indicates an improvement in fatigue.
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Timepoint [9]
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Baseline and Week 8
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Secondary outcome [10]
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Change from Baseline in Pain Severity as Measured by Item 3 of the Brief Pain Inventory (BPI)
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Assessment method [10]
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Item 3 of the BPI records a participants' pain on a scale from 1 to 10, where pain is mild (score of 1 to 4), moderate (score of 5 to 6), or severe (score of 7 to 10). An increase in score from baseline indicates a worsening of pain. A decrease in score from baseline indicates a lessening of pain.
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Timepoint [10]
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Baseline and Week 8
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Secondary outcome [11]
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Change from Baseline in Physical Functioning as Measured by the Physical Function Domain of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core Questionnaire (EORTC QLQ-C30)
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Assessment method [11]
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The physical function domain of the EORTC QLQ-C30 assesses a participants' quality of life regarding their physical function on a scale from 1 to 4, with higher scores indicating a worse outcome. An increase in score from baseline indicates a worsening of physical functioning. A decrease in score from baseline indicates an improvement in physical functioning.
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Timepoint [11]
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Baseline and Week 8
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Secondary outcome [12]
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Change from Baseline in Global Health Status as Measured by Questions 29 and 30 of the EORTC QLQ-C30
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Assessment method [12]
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Questions 29 and 30 of the EORTC QLQ-C30 assess a participants' global health status on a scale from 1 to 7, with higher scores indicating a better outcome. An increase in score from baseline indicates an improvement in global health status. A decrease in score from baseline indicates a worsening in global health status.
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Timepoint [12]
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0
Baseline and Week 8
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Secondary outcome [13]
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Change from Baseline For All Subscales of the BFI
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Assessment method [13]
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The BFI is a questionnaire that includes 3 items to assess fatigue severity and 5 items to assess interference due to fatigue, with each item reported on a numeric rating scale from 0 to 10. Higher scores indicate a higher severity of fatigue. An increase in score from baseline indicates a worsening of fatigue. A decrease in score from baseline indicates an improvement in fatigue.
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Timepoint [13]
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Baseline and Week 8
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Secondary outcome [14]
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Change from Baseline For All Subscales of the BPI
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Assessment method [14]
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The BPI is a 9-item questionnaire which includes 2 body diagrams, four items to assess pain severity, four items to assess pain interference and one question about percentage of pain relief by analgesics. The level of pain and pain interference assessed can be divided into categories based on score of mild (1 to 4), moderate (5 to 6), and severe (7 to 10). An increase in score from baseline indicates a worsening of pain. A decrease in score from baseline indicates a lessening of pain.
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Timepoint [14]
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Baseline and Week 8
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Secondary outcome [15]
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Change from Baseline For All Subscales and Domains of EORTC QLQ-C30
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Assessment method [15]
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The EORTC QLQ-C30 is a self-reporting 30-item generic instrument which assesses 5 functional domains (physical, role, emotional, cognitive, social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and a global health status/quality of life (QOL) scale. Higher scores indicate a worse outcome. An increase in score from baseline indicates a worsening of outcome. A decrease in score from baseline indicates an improvement in outcome.
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Timepoint [15]
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Baseline and Week 8
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Secondary outcome [16]
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Change from Baseline in Visual Analog Scale (VAS) Scores as Measured by EuroQol-5D level 5 (EQ-5D-5L)
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Assessment method [16]
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The EQ-5D-5L questionnaire is a 2-page, standardized instrument for use as a measure of health outcome. It is comprised of a 5-dimension health status measure and a visual analogue scale. The 5-dimension health status measure evaluates: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
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Timepoint [16]
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Baseline and Week 8
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Secondary outcome [17]
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Average Score on Single Question on Symptom Bother GP5 from Functional Assessment of Cancer Therapy - General (FACT-G)
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Assessment method [17]
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The GP5 from the FACT-G is a single item included in the Physical Well-Being subscale of the FACT-G. Responses to the item: "I am bothered by side effects of treatment" are rated on a 5-point Likert scale from "not at all" to "very much".
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Timepoint [17]
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Approximately 2 years
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Secondary outcome [18]
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Average Score of Patient Global Impression of Change (PGIC)
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Assessment method [18]
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The PGIC scale consists of one item which measures the participants' perception of change in their condition relative to the beginning of the study. Responses are rated on a 7-item response scale ranging from very much improved to very much worse.
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Timepoint [18]
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Approximately 2 years
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Secondary outcome [19]
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Maximum Plasma Concentration (Cmax) of Sotorasib
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Assessment method [19]
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Timepoint [19]
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Day 1 to approximately 2 years
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Secondary outcome [20]
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Cmax of Panitumumab
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Assessment method [20]
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Timepoint [20]
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Day 1 to approximately 2 years
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Secondary outcome [21]
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Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib
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Assessment method [21]
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Timepoint [21]
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Day 1 to approximately 2 years
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Secondary outcome [22]
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AUC of Panitumumab
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Assessment method [22]
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Timepoint [22]
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Day 1 to approximately 2 years
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Eligibility
Key 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 prospective central testing, using the analytically validated Qiagen Therascreen KRAS RGQ polymerase chain reaction Kit in CRC as an investigational device demonstrating a KRAS p.G12C mutation is present. Local testing and documentation of KRAS p.G12C mutation should have been previously performed as part of standard of care.
* 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 2 weeks prior to cycle 1 day 1:
* 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, total bilirubin or direct bilirubin needs to be =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.
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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
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
19/04/2022
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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
12/03/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Chris OBrien Lifehouse - Camperdown
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Recruitment hospital [2]
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GenesisCare -North Shore (Oncology) - St Leonards
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Recruitment hospital [3]
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Westmead Hospital - Westmead
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Recruitment hospital [4]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment postcode(s) [1]
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2050 - Camperdown
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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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2145 - Westmead
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Recruitment postcode(s) [4]
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5011 - Woodville South
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Florida
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Georgia
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Michigan
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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France
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Lyon Cédex 3
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France
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Montpellier Cedex 5
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France
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Paris
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France
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Pessac
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Berlin
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Germany
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Dresden
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Germany
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Goettingen
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Germany
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Muenchen
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Germany
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Tuebingen
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Heraklion - Crete
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Patra
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Genova
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Lecce
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Milano
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Monserrato CA
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Napoli
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Roma
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Tricase
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Chiba
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Japan
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Fukuoka
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Hyogo
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Osaka
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Shizuoka
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Tokyo
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Ciudad de Mexico
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Andalucía
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Cantabria
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Cataluña
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Comunidad Valenciana
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Galicia
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Navarra
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Madrid
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Taiwan
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Kaohsiung
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Taiwan
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State/province [67]
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Tainan
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Taiwan
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Taipei
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Country [69]
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Taiwan
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Taoyuan
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Country [70]
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Maidstone
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United Kingdom
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Northwood
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Ethics approval
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Summary
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 QD and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).
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Trial website
https://clinicaltrials.gov/study/NCT05198934
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Trial related presentations / publications
Fakih MG, Salvatore L, Esaki T, Modest DP, Lopez-Bravo DP, Taieb J, Karamouzis MV, Ruiz-Garcia E, Kim TW, Kuboki Y, Meriggi F, Cunningham D, Yeh KH, Chan E, Chao J, Saportas Y, Tran Q, Cremolini C, Pietrantonio F. Sotorasib plus Panitumumab in Refractory Colorectal Cancer with Mutated KRAS G12C. N Engl J Med. 2023 Dec 7;389(23):2125-2139. doi: 10.1056/NEJMoa2308795. Epub 2023 Oct 22.
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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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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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.
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Available to whom?
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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05198934