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To evaluate safety, tolerability, PK, and preliminary efficacy of AMG 510 PO QD in subjects of Chinese descent with KRAS p.G12C-mutant advanced/metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Subjects will be enrolled and will receive AMG 510 PO QD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 510 | Drug | Subjects will be enrolled and will receive AMG 510 PO QD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLT) | DLTs were defined as any of the following adverse events (AEs) where a relationship to sotorasib could not be ruled out. Hematological toxicity
Non-hematological toxicity
| Day 1 to Day 21 |
| Number of Participants With Treatment-emergent AEs (TEAEs) | An AE was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE was defined as an AE starting on or after first dose of study treatment. Treatment-related TEAEs were any TEAEs considered related to investigational product by the investigator. If relationship was missing, the event was assumed treatment-related. Clinically significant changes from the participant's baseline values in vital signs, 12-lead electrocardiograms, and clinical laboratory safety tests were reported as AEs. | Day 1 until the end of study (or primary data cut-off date for ongoing participants); median [min, max] duration was 5.57 [1.5, 13.7] months |
| Maximum Observed Plasma Concentration (Cmax) of Sotorasib | Pharmacokinetic (PK) parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8 |
| Time to Achieve Cmax (Tmax) of Sotorasib | PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response (OR) | Measured by computed tomography (CT) or magnetic resonance imaging (MRI). Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. | Day 1 until the end of study (approximately 12 months) |
| Duration of Response (DoR) |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hong Kong, Queen Mary Hospital | Hong Kong | Hong Kong | ||||
| Prince of Wales Hospital |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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 (or other new use) 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.
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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Administration of sotorasib orally (PO) once daily (QD) was permitted to continue until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent. The primary analysis occurred after all participants enrolled had the opportunity to complete 6 months on study or withdrew from study.
A total of 12 participants were enrolled in the study in Hong Kong and Taiwan. The study is currently ongoing; results are reported up to the primary data cut-off date of 31 December 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sotorasib | Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set: all enrolled participants who received at least 1 dose of sotorasib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sotorasib | Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLT) | DLTs were defined as any of the following adverse events (AEs) where a relationship to sotorasib could not be ruled out. Hematological toxicity
Non-hematological toxicity
| DLT analysis set: DLT-evaluable subjects (participants who either experienced a DLT or did not experience a DLT but received at least 80% of the planned doses of investigational product within the 21-day DLT window) in the safety analysis set. | Posted | Count of Participants | Participants | Day 1 to Day 21 |
|
Day 1 until the end of study (or primary data cut-off date for ongoing participants); median [min, max] duration was 5.57 [1.5, 13.7] months
Safety analysis set: all enrolled participants who received at least 1 dose of sotorasib.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sotorasib | Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2022 | Oct 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2022 | Oct 28, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000706028 | sotorasib |
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| Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8 |
| Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Sotorasib | PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8 |
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. |
| Day 1 until the end of study (approximately 12 months) |
| Progression-free Survival (PFS) | Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. | Day 1 until the end of study (approximately 12 months) |
| Disease Control Rate (DCR) | Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. | Day 1 until the end of study (approximately 12 months) |
| Time to Response (TTR) | Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. | Day 1 until the end of study (approximately 12 months) |
| Duration of Stable Disease | Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. | Day 1 until the end of study (approximately 12 months) |
| Shatin, New Territories |
| Hong Kong |
| Veterans General Hospital - Taichung | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Sotorasib |
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent. |
|
|
| Primary | Number of Participants With Treatment-emergent AEs (TEAEs) | An AE was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE was defined as an AE starting on or after first dose of study treatment. Treatment-related TEAEs were any TEAEs considered related to investigational product by the investigator. If relationship was missing, the event was assumed treatment-related. Clinically significant changes from the participant's baseline values in vital signs, 12-lead electrocardiograms, and clinical laboratory safety tests were reported as AEs. | Safety analysis set: all enrolled participants who received at least 1 dose of sotorasib. | Posted | Count of Participants | Participants | Day 1 until the end of study (or primary data cut-off date for ongoing participants); median [min, max] duration was 5.57 [1.5, 13.7] months |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Sotorasib | Pharmacokinetic (PK) parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. | PK analysis set: all participants who received at least 1 dose of sotorasib and had at least 1 PK sample collected. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8 |
|
|
|
| Primary | Time to Achieve Cmax (Tmax) of Sotorasib | PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. | PK analysis set: all participants who received at least 1 dose of sotorasib and had at least 1 PK sample collected. | Posted | Median | Full Range | hours | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8 |
|
|
|
| Primary | Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Sotorasib | PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval. | PK analysis set: all participants who received at least 1 dose of sotorasib and had at least 1 PK sample collected. | Posted | Mean | Standard Deviation | hours*ng/mL | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8 |
|
|
|
| Secondary | Objective Response (OR) | Measured by computed tomography (CT) or magnetic resonance imaging (MRI). Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. | Not Posted | Feb 2027 | Day 1 until the end of study (approximately 12 months) | Participants |
| Secondary | Duration of Response (DoR) | Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. | Not Posted | Feb 2027 | Day 1 until the end of study (approximately 12 months) | Participants |
| Secondary | Progression-free Survival (PFS) | Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. | Not Posted | Feb 2027 | Day 1 until the end of study (approximately 12 months) | Participants |
| Secondary | Disease Control Rate (DCR) | Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. | Not Posted | Feb 2027 | Day 1 until the end of study (approximately 12 months) | Participants |
| Secondary | Time to Response (TTR) | Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. | Not Posted | Feb 2027 | Day 1 until the end of study (approximately 12 months) | Participants |
| Secondary | Duration of Stable Disease | Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. | Not Posted | Feb 2027 | Day 1 until the end of study (approximately 12 months) | Participants |
| 2 |
| 12 |
| 6 |
| 12 |
| 11 |
| 12 |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Euthyroid sick syndrome | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Xerosis | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
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