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Therapy Name	CUDC-907
Synonyms
Therapy Description	CUDC-907 (fimepinostat) is a dual PI3K and HDAC inhibitor, which prevents activation of the PI3K-AKT-mTOR signal transduction pathway, inhibits tumor cell growth, and promotes apoptosis in cancer cells (PMID: 22693356, PMID: 32459381).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
CUDC-907		Fimepinostat	HDAC Inhibitor 45 PI3K Inhibitor (Pan) 42	CUDC-907 (fimepinostat) is a dual PI3K and HDAC inhibitor, which prevents activation of the PI3K-AKT-mTOR signal transduction pathway, inhibits tumor cell growth, and promotes apoptosis in cancer cells (PMID: 22693356, PMID: 32459381).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
PIK3CA mutant	hematologic cancer	sensitive	CUDC-907	Preclinical - Cell line xenograft	Actionable	In a preclinical study, CUDC-907 inhibited PIK3CA, blocked downstream AKT pathway activation, and induced apoptosis and cell cycle arrest in both PIK3CA wild-type and PIK3CA mutant human cancer cell lines and xenograft models of multiple solid and hematologic cancers (PMID: 22693356).	22693356
PIK3CA mutant	Advanced Solid Tumor	sensitive	CUDC-907	Preclinical - Cell line xenograft	Actionable	In a preclinical study, CUDC-907 inhibited PIK3CA, blocked downstream AKT pathway activation, and induced apoptosis and cell cycle arrest in both PIK3CA wild-type and PIK3CA mutant human cancer cell lines and xenograft models of multiple tumor types (PMID: 22693356).	22693356
PTEN del	breast cancer	sensitive	CUDC-907	Preclinical - Cell culture	Actionable	In a preclinical study, CUDC-907 inhibited growth of breast cancer cells lines harboring Pten mutations and/or deletions (PMID: 22693356).	22693356
PTEN mutant	breast cancer	sensitive	CUDC-907	Preclinical - Cell culture	Actionable	In a preclinical study, CUDC-907 inhibited growth of breast cancer cells lines harboring Pten mutations and/or deletions (PMID: 22693356).	22693356
PIK3CA mutant	breast cancer	sensitive	CUDC-907	Preclinical	Actionable	In a preclinical study, CUDC-907 inhibited growth of human breast cancer cell lines harboring PIK3CA mutations in culture (PMID: 22693356).	22693356

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02909777	Phase I	CUDC-907	Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma	Active, not recruiting	USA	0
NCT03893487	Phase I	CUDC-907	Fimepinostat in Treating Brain Tumors in Children and Young Adults (PNOC016)	Active, not recruiting	USA \| CHE	0
NCT01742988	Phase Ib/II	Bendamustine + CUDC-907 + Rituximab CUDC-907 + Rituximab CUDC-907 CUDC-907 + Venetoclax	Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma	Completed	USA	0
NCT02307240	Phase I	CUDC-907	Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors	Completed	USA	0
NCT02674750	Phase II	CUDC-907	Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations	Completed	USA \| ESP	0
NCT03002623	Phase II	CUDC-907	CUDC-907 Treatment in People With Metastatic and Locally Advanced Thyroid Cancer	Terminated	USA	0

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