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Therapy Name | GDC-0084 |
Synonyms | |
Therapy Description |
Paxalisib (GDC-0084) is a dual pan-PI3K and mTOR inhibitor, which prevents cell proliferation and potentially inhibits tumor growth (PMID: 22619466, PMID: 32269051, PMID: 31937616). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
GDC-0084 | GDC0084|Paxalisib | mTOR Inhibitor 51 PI3K Inhibitor (Pan) 42 | Paxalisib (GDC-0084) is a dual pan-PI3K and mTOR inhibitor, which prevents cell proliferation and potentially inhibits tumor growth (PMID: 22619466, PMID: 32269051, PMID: 31937616). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
PTEN loss | glioblastoma | sensitive | GDC-0084 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, two PTEN-deficient glioblastoma cell line xenograft models were sensitive to GDC-0084 treatment, resulting in decreased tumor volumes by 70% and 40%, and inhibition of PI3K pathway signaling (PMID: 27638506). | 27638506 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03522298 | Phase II | GDC-0084 | Safety, Pharmacokinetics and Efficacy of GDC-0084 in Newly-diagnosed Glioblastoma Multiforme | Completed | USA | 0 |
NCT03696355 | Phase I | GDC-0084 | Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas | Completed | USA | 0 |
NCT04192981 | Phase I | GDC-0084 | GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases | Active, not recruiting | USA | 0 |
NCT01547546 | Phase I | GDC-0084 | A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma | Completed | USA | ESP | 0 |
NCT03994796 | Phase II | Abemaciclib GDC-0084 Entrectinib | Genetic Testing in Guiding Treatment for Patients With Brain Metastases | Recruiting | USA | 0 |
NCT04906096 | Phase II | GDC-0084 | Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL | Recruiting | USA | 0 |