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The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence ABC | Experimental | Participants will be administered sotorasib dose A orally in the following order:
|
|
| Treatment Sequence BAC | Experimental | Participants will be administered sotorasib dose A orally in the following order:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotorasib | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma pharmacokinetic (PK) parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified. | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1) and Day 4 (Period 2) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib for Treatments A and B | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma PK parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified. | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1) and Day 4 (Period 2) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Sotorasib for Treatments A and B | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma PK parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified. | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1) and Day 4 (Period 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Treatment-emergent AE (TEAE) | An AE is any untoward medical occurrence in a participant irrespective of a causal relationship with the study treatment. Any abnormal clinical laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., 12-lead electrocardiogram or vital signs measurements), including those that worsen from baseline, that are considered clinically significant in the medical and scientific judgment of the Investigator (i.e., not related to progression of underlying disease) were considered AEs. |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Daytona Beach | Florida | 32117 | United States | ||
| Covance Clinical Research Unit |
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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 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. 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.
After randomization, participants received Treatment A (test 1) and Treatment B (reference) according to the treatment sequence assigned. A group of participants from both arm proceeded to receive Treatment C (test 2) with a high-fat meal. Dose administration of sotorasib occurred on Day 1 (Period 1) and Day 4 (Period 2) under fasted conditions and on Day 7 (Period 3) under fed condition.
Overall, 145 participants were enrolled in the study in the United States between 16 August 2021 and 18 February 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence AB | Participants were administered 960 mg sotorasib orally in the following order:
|
| FG001 | Treatment Sequence BA | Participants were administered 960 mg sotorasib orally in the following order:
|
| FG002 | Treatment Sequence ABC | Participants were administered 960 mg sotorasib orally in the following order:
|
| FG003 | Treatment Sequence BAC | Participants were administered 960 mg sotorasib orally in the following order:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| ||||||||||||||||||||||||
| Period 2 |
| |||||||||||||||||||||||||
| Period 3 |
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The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence AB | Participants were administered 960 mg sotorasib orally in the following order:
|
| BG001 | Treatment Sequence BA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma pharmacokinetic (PK) parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified. | The PK population included all participants who received at least 1 dose of sotorasib in Periods 1 and 2, and had evaluable PK data. A participant may have been excluded from the PK summary statistics and statistical analysis if the participant had an adverse event (AE) of vomiting that occurred at or before 2 times median time of the Cmax (tmax) or diarrhea within 24 hours of dosing. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1) and Day 4 (Period 2) |
|
Day 1 to Day 9
The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
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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 | Treatment A | One administration of 960 mg sotorasib administered orally as 3 tablets (test 1) in Period 1 or Period 2, depending on treatment sequence assigned. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 24.0 | 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 9, 2021 | Nov 2, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2021 | Nov 2, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000706028 | sotorasib |
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| Day 1 to Day 9 |
| Food Effect: Cmax of Sotorasib | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3) |
| Food Effect: AUClast of Sotorasib | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3) |
| Food Effect: AUCinf of Sotorasib | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3) |
| Dallas |
| Texas |
| 75247 |
| United States |
| Administered Treatment A |
|
| Administered Treatment B |
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| COMPLETED |
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| NOT COMPLETED |
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| Administered Treatment C |
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| COMPLETED |
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| NOT COMPLETED |
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Participants were administered 960 mg sotorasib orally in the following order:
| BG002 | Treatment Sequence ABC | Participants were administered 960 mg sotorasib orally in the following order:
|
| BG003 | Treatment Sequence BAC | Participants were administered 960 mg sotorasib orally in the following order:
|
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
One administration of 960 mg sotorasib administered orally as 3 tablets (test 1) in Period 1 or Period 2, depending on treatment sequence assigned. |
| OG001 | Treatment B | One administration of 960 mg sotorasib administered orally as 8 tablets (reference) in Period 1 or Period 2, depending on treatment sequence assigned. |
|
|
|
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib for Treatments A and B | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma PK parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified. | The PK population included all participants who received at least 1 dose of sotorasib in Periods 1 and 2, and had evaluable PK data. A participant may have been excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 times median tmax or diarrhea within 24 hours of dosing. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1) and Day 4 (Period 2) |
|
|
|
|
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Sotorasib for Treatments A and B | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma PK parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified. | The PK population included all participants who received at least 1 dose of sotorasib in Periods 1 and 2, and had evaluable PK data. A participant may have been excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 times median tmax or diarrhea within 24 hours of dosing. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1) and Day 4 (Period 2) |
|
|
|
|
| Secondary | Number of Participants Who Experienced a Treatment-emergent AE (TEAE) | An AE is any untoward medical occurrence in a participant irrespective of a causal relationship with the study treatment. Any abnormal clinical laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., 12-lead electrocardiogram or vital signs measurements), including those that worsen from baseline, that are considered clinically significant in the medical and scientific judgment of the Investigator (i.e., not related to progression of underlying disease) were considered AEs. | The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment. | Posted | Count of Participants | Participants | Day 1 to Day 9 |
|
|
|
| Secondary | Food Effect: Cmax of Sotorasib | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. | The PK population included all participants who received at least 1 dose of sotorasib in Period 3 and had evaluable PK data. A participant may have been excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 times median tmax or diarrhea within 24 hours of dosing. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3) |
|
|
|
|
| Secondary | Food Effect: AUClast of Sotorasib | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. | The PK population included all participants who received at least 1 dose of sotorasib in Period 3 and had evaluable PK data. A participant may have been excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 times median tmax or diarrhea within 24 hours of dosing. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3) |
|
|
|
|
| Secondary | Food Effect: AUCinf of Sotorasib | Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. | The PK population included all participants who received at least 1 dose of sotorasib in Period 3 and had evaluable PK data. A participant may have been excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 times median tmax or diarrhea within 24 hours of dosing. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3) |
|
|
|
|
| 0 |
| 145 |
| 0 |
| 145 |
| 8 |
| 145 |
| EG001 | Treatment B | One administration of 960 mg sotorasib administered orally as 8 tablets (reference) in Period 1 or Period 2, depending on treatment sequence assigned. | 0 | 145 | 0 | 145 | 10 | 145 |
| EG002 | Treatment C | One administration of 960 mg sotorasib administered orally as 3 tablets with a high-fat meal (test 2) in Period 3. | 0 | 13 | 0 | 13 | 0 | 13 |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Post procedural contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Sars-cov-2 test positive | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | 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.