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Therapy Name | GDC-0084 |
Synonyms | |
Therapy Description |
GDC-0084 is a dual pan-PI3K and mTOR inhibitor, which prevents cell proliferation and potentially inhibits tumor growth (PMID: 22619466). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
GDC-0084 | GDC0084|Paxalisib | mTOR Inhibitor 51 PI3K Inhibitor (Pan) 38 | 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 |
---|---|---|---|---|---|---|---|
Unknown unknown | malignant glioma | not applicable | GDC-0084 | Phase I | Actionable | In a Phase I trial, GDC-0084 treatment demonstrated expected toxicity and blood-brain barrier penetration, resulted in stable disease as best response in 40% (19/47) of patients with recurrent high-grade glioma (J Clin Oncol (PMID: 31937616; NCT01547546). | 31937616 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03696355 | Phase I | GDC-0084 | Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas | Active, not recruiting | USA | 0 |
NCT03522298 | Phase II | GDC-0084 | Safety, Pharmacokinetics and Efficacy of GDC-0084 in Newly-diagnosed Glioblastoma Multiforme | Active, not recruiting | USA | 0 |
NCT03994796 | Phase II | Abemaciclib GDC-0084 Entrectinib | Genetic Testing in Guiding Treatment for Patients With Brain Metastases | Recruiting | USA | 0 |
NCT01547546 | Phase I | GDC-0084 | A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma | Completed | USA | 1 |
NCT04192981 | Phase I | GDC-0084 | GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases | Recruiting | USA | 0 |