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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). |
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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
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 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 |
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 |
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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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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 |
NCT03893487 | Phase I | CUDC-907 | Fimepinostat in Treating Brain Tumors in Children and Young Adults (PNOC016) | Active, not recruiting | USA | CHE | 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 |
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 |
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 |
NCT03002623 | Phase II | CUDC-907 | CUDC-907 Treatment in People With Metastatic and Locally Advanced Thyroid Cancer | Terminated | USA | 0 |