Informations générales (source: ClinicalTrials.gov)
A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)
Interventional
Phase 1/Phase 2
Amgen (Voir sur ClinicalTrials)
août 2018
mai 2028
05 octobre 2024
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C
mutant advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in
adult subjects with KRAS p.G12C mutant advanced solid tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 29/03/2024 01:28:36 | Contacter | ||
| CLCC INSTITUT CURIE | 04/06/2024 14:01:30 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 21/11/2023 08:39:37 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopital de la Timone - 13385 - Marseille cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - 31059 - Toulouse cedex 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS
p.G12C mutation identified through molecular testing.
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.
- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS
p.G12C mutation identified through molecular testing.
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.