Therapy Detail

Therapy Name CUDC-907
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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
CUDC-907 Fimepinostat HDAC Inhibitor 34 PI3K Inhibitor (Pan) 34 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown non-Hodgkin lymphoma not applicable CUDC-907 Preclinical - Cell line xenograft Actionable In a preclinical study, CUDC-907 inhibited cell growth in a human non-Hodgkin lymphoma cell line in culture, and stabilized tumor growth in xenograft models (PMID: 22693356). 22693356
KRAS G12A multiple myeloma sensitive CUDC-907 Preclinical Actionable In a preclinical study, CUDC-907 induced caspase activation and apoptosis in a human multiple myeloma cell line harboring KRAS G12A in culture (PMID: 19490892, PMID: 22693356). 19490892 22693356
Unknown unknown hematologic cancer not applicable CUDC-907 Phase I Actionable In a Phase I trial, CUDC-907 treatment was well-tolerated, demonstrated safety, and resulted in stable disease in 57% (21/37) of patients with a hematological cancer (PMID: 27049457). 27049457
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
KRAS mutant Advanced Solid Tumor sensitive CUDC-907 Preclinical - Cell line xenograft Actionable In a preclinical study, CUDC-907 induced apoptosis and cell cycle arrest in several human solid tumor and hematological cancer cell lines in culture and inhibited tumor growth in tumor cell line xenograft models, including those harboring KRAS mutations (PMID: 22693356). 22693356
Unknown unknown Ewing sarcoma not applicable CUDC-907 Phase I Actionable In a Phase I trial, CUDC-907 treatment resulted in stable disease for 6 treatment cycles in a pediatric patient with Ewing sarcoma (Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 10542-10542; NCT02909777). detail...
KRAS Q61H non-small cell lung carcinoma sensitive CUDC-907 Preclinical Actionable In a preclinical study, CUDC-907 inhibited growth and repressed RAF-MEK-MAPK signaling as indicated by reduced phosphorylation of Craf, Mek, and Mapk in a human non-small cell lung cancer cell line harboring KRAS Q61H in culture (PMID: 19165201, PMID: 22693356). 22693356 19165201
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
Unknown unknown pediatric ependymoma not applicable CUDC-907 Phase I Actionable In a Phase I trial, CUDC-907 treatment resulted in stable disease for 6 treatment cycles in a pediatric patient with ependymoma (Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 10542-10542; NCT02909777). detail...
Unknown unknown diffuse large B-cell lymphoma not applicable CUDC-907 Phase I Actionable In a Phase I trial, CUDC-907 was well-tolerated, demonstrated safety, and resulted in a 56% (5/9) objective response rate, including two complete responses and three partial responses, in patients with diffuse large B-cell lymphoma (PMID: 27049457). 27049457
Clinical Trial Phase Therapies Title Recruitment Status
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 Active, not recruiting
NCT03002623 Phase II CUDC-907 CUDC-907 Treatment in People With Metastatic and Locally Advanced Thyroid Cancer Terminated
NCT01742988 Phase I CUDC-907 Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Patients With Lymphoma or Multiple Myeloma Active, not recruiting
NCT02909777 Phase I CUDC-907 Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma Recruiting
NCT02674750 Phase II CUDC-907 + Rituximab CUDC-907 Study to Evaluate the Efficacy and Safety of CUDC-907 With and Without Rituximab in Patients With RR MYC-Altered DLBCL Recruiting