Therapy Detail

Therapy Name Belinostat
Therapy Description

Beleodaq (belinostat) is an HDAC inhibitor, which promotes tumor cell apoptosis, potentially leading to decreased tumor growth (PMID: 12939461, PMID: 16928830, PMID: 17935615). Beleodaq (belinostat) is FDA approved for patients with relapsed or refractory peripheral T-cell lymphoma (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Belinostat Beleodaq PDX101|NSC726630|PX-105684 HDAC Inhibitor 34 Beleodaq (belinostat) is an HDAC inhibitor, which promotes tumor cell apoptosis, potentially leading to decreased tumor growth (PMID: 12939461, PMID: 16928830, PMID: 17935615). Beleodaq (belinostat) is FDA approved for patients with relapsed or refractory peripheral T-cell lymphoma (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FBXW7 inact mut Advanced Solid Tumor sensitive Belinostat Preclinical Actionable In a preclinical study, Beleodaq (belinostat) inhibited human cancer cell lines harboring FBXW7 inactivating mutations in culture (PMID: 23274910). 23274910
Unknown unknown Advanced Solid Tumor not applicable Belinostat Phase I Actionable In a Phase I trial, Beleodaq (belinostat) demonstrated safety and promoted stable disease in 39% (18/46) of patients with a variety of solid tumors (PMID: 18245542). 18245542
FBXW7 inact mut hematologic cancer sensitive Belinostat Preclinical Actionable In a preclinical study, Beleodaq (belinostat) inhibited human hematologic cancer cell lines harboring FBXW7 inactivating mutations in culture (PMID: 23274910). 23274910
Unknown unknown peripheral T-cell lymphoma not applicable Belinostat FDA approved Actionable In clinical trials that supported FDA approval, treatment with Beleodaq (belinostat) resulted in an objective response rate of 25.8% (31/120) and a median overall survival of 7.9 months in patients with peripheral T-cell lymphoma (PMID: 26101246). 26101246
Clinical Trial Phase Therapies Title Recruitment Status
NCT01686165 Phase II Belinostat Rituximab Belinostat and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Aggressive B-Cell Non-Hodgkin Lymphoma Completed
NCT02680795 Phase I Belinostat To Evaluate the Safety and Pharmacokinetics of Belinostat in Patients Who Have Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes Recruiting
NCT03432741 Phase I Carfilzomib Daratumumab Obinutuzumab Gemcitabine Trastuzumab Romidepsin Nivolumab Rituximab Belinostat Pembrolizumab Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer Recruiting
NCT02679131 Phase I Belinostat To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment. Terminated
NCT02532192 Phase I Rituximab Cisplatin Dexamethasone Cytarabine Fluconazole Belinostat A Phase Ib Study of Belinostat With RDHAP Chemotherapy (Dexamethasone, Cytarabine, Cisplatinum) in Adults With Relapsed or Refractory Diffuse Large B-cell Lymphoma Withdrawn
NCT02701673 Phase Ib/II Azacitidine Pyridoxine Gemcitabine Belinostat Busulfan Melphalan Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma Withdrawn
NCT01273155 Phase I Belinostat Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction Completed
NCT02142530 Phase I Belinostat Carfilzomib Carfilzomib Plus Belinostat in Relapsed/Refractory NHL Completed