Trial Outcomes & Findings for AMG 510 Ethnic Sensitivity Study (CodeBreaK 105). (NCT NCT04380753)
NCT ID: NCT04380753
Last Updated: 2026-05-06
Results Overview
DLTs were defined as any of the following adverse events (AEs) where a relationship to sotorasib could not be ruled out. Hematological toxicity * febrile neutropenia * neutropenic infection * grade 4 neutropenia * grade ≥ 3 thrombocytopenia for \> 7 days * grade 3 thrombocytopenia with grade ≥ 2 bleeding * grade 4 thrombocytopenia * grade 4 anemia. Non-hematological toxicity * grade ≥ 4 vomiting or diarrhea * grade 3 diarrhea or grade 3 vomiting lasting more than 3 days despite optimal medical support * grade ≥ 3 nausea for 3 days or more despite optimal medical support * any other grade ≥ 3 adverse event.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 1 to Day 21
Results posted on
2026-05-06
Participant Flow
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.
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.
Participant milestones
| Measure |
Sotorasib
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Sotorasib
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
|
|---|---|
|
Overall Study
Participants continuing study
|
4
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).
Baseline characteristics by cohort
| Measure |
Sotorasib
n=12 Participants
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
|
|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 13.3 • n=54 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 21Population: 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.
DLTs were defined as any of the following adverse events (AEs) where a relationship to sotorasib could not be ruled out. Hematological toxicity * febrile neutropenia * neutropenic infection * grade 4 neutropenia * grade ≥ 3 thrombocytopenia for \> 7 days * grade 3 thrombocytopenia with grade ≥ 2 bleeding * grade 4 thrombocytopenia * grade 4 anemia. Non-hematological toxicity * grade ≥ 4 vomiting or diarrhea * grade 3 diarrhea or grade 3 vomiting lasting more than 3 days despite optimal medical support * grade ≥ 3 nausea for 3 days or more despite optimal medical support * any other grade ≥ 3 adverse event.
Outcome measures
| Measure |
Sotorasib
n=12 Participants
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
|
|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLT)
|
0 Participants
|
PRIMARY outcome
Timeframe: 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] monthsPopulation: Safety analysis set: all enrolled participants who received at least 1 dose of sotorasib.
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.
Outcome measures
| Measure |
Sotorasib
n=12 Participants
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
|
|---|---|
|
Number of Participants With Treatment-emergent AEs (TEAEs)
Any TEAEs
|
11 Participants
|
|
Number of Participants With Treatment-emergent AEs (TEAEs)
Any Treatment-related TEAEs
|
4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8Population: PK analysis set: all participants who received at least 1 dose of sotorasib and had at least 1 PK sample collected.
Pharmacokinetic (PK) parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.
Outcome measures
| Measure |
Sotorasib
n=12 Participants
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Sotorasib
Day 1
|
9010 ng/mL
Standard Deviation 5200
|
|
Maximum Observed Plasma Concentration (Cmax) of Sotorasib
Day 8
|
6330 ng/mL
Standard Deviation 3030
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8Population: PK analysis set: all participants who received at least 1 dose of sotorasib and had at least 1 PK sample collected.
PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.
Outcome measures
| Measure |
Sotorasib
n=12 Participants
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
|
|---|---|
|
Time to Achieve Cmax (Tmax) of Sotorasib
Day 1
|
0.85 hours
Interval 0.5 to 6.0
|
|
Time to Achieve Cmax (Tmax) of Sotorasib
Day 8
|
0.96 hours
Interval 0.47 to 5.9
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8Population: PK analysis set: all participants who received at least 1 dose of sotorasib and had at least 1 PK sample collected.
PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.
Outcome measures
| Measure |
Sotorasib
n=12 Participants
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
|
|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Sotorasib
Day 1
|
73200 hours*ng/mL
Standard Deviation 43700
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Sotorasib
Day 8
|
37400 hours*ng/mL
Standard Deviation 32000
|
SECONDARY outcome
Timeframe: Day 1 until the end of study (approximately 12 months)Measured by computed tomography (CT) or magnetic resonance imaging (MRI). Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 until the end of study (approximately 12 months)Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 until the end of study (approximately 12 months)Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 until the end of study (approximately 12 months)Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 until the end of study (approximately 12 months)Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 until the end of study (approximately 12 months)Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Outcome measures
Outcome data not reported
Adverse Events
Sotorasib
Serious events: 6 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Sotorasib
n=12 participants at risk
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
|
|---|---|
|
Gastrointestinal disorders
Ileus
|
8.3%
1/12 • 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.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • 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.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • 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.
|
|
Investigations
Liver function test abnormal
|
8.3%
1/12 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • 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.
|
|
Nervous system disorders
Spinal cord compression
|
8.3%
1/12 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
16.7%
2/12 • 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.
|
Other adverse events
| Measure |
Sotorasib
n=12 participants at risk
Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • 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.
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • 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.
|
|
Endocrine disorders
Adrenal insufficiency
|
8.3%
1/12 • 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.
|
|
Endocrine disorders
Euthyroid sick syndrome
|
8.3%
1/12 • 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.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • 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.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • 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.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • 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.
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
2/12 • 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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
1/12 • 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.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • 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.
|
|
General disorders
Mucosal inflammation
|
8.3%
1/12 • 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.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • 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.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • 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.
|
|
General disorders
Xerosis
|
8.3%
1/12 • 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.
|
|
Infections and infestations
Herpes simplex
|
8.3%
1/12 • 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.
|
|
Infections and infestations
Pneumonia
|
16.7%
2/12 • 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.
|
|
Infections and infestations
Rash pustular
|
8.3%
1/12 • 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.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • 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.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
8.3%
1/12 • 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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
8.3%
1/12 • 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.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • 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.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • 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.
|
|
Investigations
Blood bilirubin increased
|
8.3%
1/12 • 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.
|
|
Investigations
Weight increased
|
8.3%
1/12 • 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.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.3%
1/12 • 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.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
8.3%
1/12 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • 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.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
1/12 • 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.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • 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.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • 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.
|
|
Nervous system disorders
Lumbar radiculopathy
|
8.3%
1/12 • 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.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
8.3%
1/12 • 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.
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
1/12 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
8.3%
1/12 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • 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.
|
|
Skin and subcutaneous tissue disorders
Papule
|
8.3%
1/12 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
8.3%
1/12 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER