AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).
- Conditions
- Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation
- Interventions
- Registration Number
- NCT04380753
- Lead Sponsor
- Amgen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
Not provided
- Active brain metastases from non-brain tumors.
- Myocardial infarction within 6 months of study day 1.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm AMG 510 Subjects will be enrolled and will receive AMG 510 PO QD.
- Primary Outcome Measures
Name Time Method Number of Participants With Dose-limiting Toxicities (DLT) Day 1 to Day 21 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.Number of Participants With Treatment-emergent AEs (TEAEs) 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 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.Maximum Observed Plasma Concentration (Cmax) of Sotorasib Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8 Pharmacokinetic (PK) parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.
Time to Achieve Cmax (Tmax) of Sotorasib Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8 PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Sotorasib Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8 PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.
- Secondary Outcome Measures
Name Time Method Duration of Response (DoR) Day 1 until the end of study (approximately 12 months) Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Time to Response (TTR) Day 1 until the end of study (approximately 12 months) Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Disease Control Rate (DCR) Day 1 until the end of study (approximately 12 months) Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Objective Response (OR) 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.
Duration of Stable Disease Day 1 until the end of study (approximately 12 months) Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Progression-free Survival (PFS) Day 1 until the end of study (approximately 12 months) Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Trial Locations
- Locations (4)
University of Hong Kong, Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Veterans General Hospital - Taichung
🇨🇳Taichung, Taiwan
Prince of Wales Hospital
🇭🇰Shatin, New Territories, Hong Kong