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Product

AMG 510

Aliases
sotorasib, Sotorasib
Name
LUMAKRAS
FDA Approved
Yes

14 clinical trials

1 organization

1 drug

8 indications

1 document

Indication
KRAS p
Indication
NSCLC
Indication
Solid Tumors with KRAS p.G12C Mutation
Indication
Healthy Participants
Indication
Healthy Control Participants
Indication
Lung Cancer
Indication
Healthy Subjects
Indication
lung cancer
Drug
sotorasib
Clinical trial
A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
Status: Recruiting, Estimated PCD: 2025-05-01
Clinical trial
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)
Status: Active (not recruiting), Estimated PCD: 2021-12-31
Clinical trial
An Open-label, Randomized, 2-period, 2-treatment Crossover Study to Assess the Effect of Food on the Pharmacokinetics of AMG 510 in Healthy Subjects
Status: Completed, Estimated PCD: 2019-11-25
Clinical trial
An Open-label, Randomized, 2-Period, 2-Treatment Crossover Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Subjects
Status: Completed, Estimated PCD: 2020-06-14
Clinical trial
An Open-label Study to Evaluate the Drug-drug Interaction Effect of Rifampin, a CYP3A4 Inducer, on the Pharmacokinetics of AMG 510 in Healthy Subjects
Status: Completed, Estimated PCD: 2019-12-01
Clinical trial
An Open-label, Drug-drug Interaction Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics of Digoxin, a P-glycoprotein Substrate, in Healthy Subjects
Status: Completed, Estimated PCD: 2019-11-19
Clinical trial
A Phase I, Open-label Study to Evaluate the Drug-drug Interactions Between Metformin and AMG 510 in Healthy Subjects
Status: Completed, Estimated PCD: 2019-11-25
Clinical trial
An Open-label Study to Evaluate the Drug-drug Interaction Effect of Omeprazole, a Proton-pump Inhibitor, on the Pharmacokinetics of AMG 510 in Healthy Subjects
Status: Completed, Estimated PCD: 2020-01-26
Clinical trial
A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis.
Status: Withdrawn, Estimated PCD: 2023-01-31
Clinical trial
An Open-label Study to Evaluate the Drug-drug Interaction Effect of Itraconazole, a CYP3A4 Inhibitor, on the Pharmacokinetics of AMG 510 in Healthy Subjects
Status: Completed, Estimated PCD: 2019-12-17
Clinical trial
An Open-label Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics of AMG 510 in Healthy Subjects Under Fed Conditions
Status: Completed, Estimated PCD: 2020-09-13
Clinical trial
A Multicenter, Open-label, Single-arm, Expanded Access Protocol of Sotorasib for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation
Status:
Clinical trial
A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
Status: Completed, Estimated PCD: 2020-03-24
Clinical trial
A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation
Status: Recruiting, Estimated PCD: 2025-10-20
Document
DailyMed Label: LUMAKRAS
Organization
Amgen Inc