Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation Clinical Trial
Official title:
A Phase 1, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects of Chinese Descent With Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation (CodeBreaK 105)
| Verified date | September 2023 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 12 |
| Est. completion date | July 15, 2024 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | Inclusion Criteria - Male or female subjects greater than or equal to 18 years old - Subject is of Chinese ancestry - Pathologically documented, advanced/metastatic solid tumor with KRAS p.G12C mutation identified Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | University of Hong Kong, Queen Mary Hospital | Hong Kong | |
| Hong Kong | Prince of Wales Hospital | Shatin, New Territories | |
| Taiwan | Veterans General Hospital - Taichung | Taichung | |
| Taiwan | National Taiwan University Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
Hong Kong, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 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. |
Day 1 to Day 21 | |
| 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. |
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. | 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. | 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. | 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. | Day 1 until the end of study (approximately 12 months) | |
| Secondary | Duration of Response (DoR) | Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines. | Day 1 until the end of study (approximately 12 months) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) |