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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).

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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).

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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

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
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
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
NCT03994796	Phase II	Adagrasib 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

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