Drugs / Belinostat
last change 3 days ago re-read 2 minutes ago

Belinostat

Small molecule

Developed for
lymphoma · myelodysplastic syndrome · peripheral T-cell lymphoma, not otherwise specified · anaplastic large cell lymphoma · cancer · mantle cell lymphoma · acute myeloid leukemia · adult T-cell leukemia/lymphoma
+79 more · angioimmunoblastic T-cell lymphoma · Burkitt lymphoma · diffuse large B-cell lymphoma · hematopoietic and lymphoid cell neoplasm · Hodgkins lymphoma · nodal marginal zone B-cell lymphoma · non-small cell lung carcinoma · ovarian carcinoma · acute myeloid leukemia with t(8;21)(q22;q22) translocation · breast cancer · cancer of unknown primary site · chronic lymphocytic leukemia/small lymphocytic lymphoma · fallopian tube cancer · follicular lymphoma · grade III lymphomatoid granulomatosis · intraocular lymphoma · large-cell immunoblastic lymphoma · MALT lymphoma · mycosis fungoides and variants · neoplasm · plasma cell myeloma · post-transplant lymphoproliferative disease · primary cutaneous T-cell lymphoma · primary peritoneal carcinoma · splenic marginal zone lymphoma · thymic carcinoma · thymoma · Waldenstrom macroglobulinemia · acute lymphoblastic leukemia · acute myeloid leukemia with 11q23 abnormalities · acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) · acute myeloid leukemia with t(9;11)(p22;q23) · acute myeloid leukemia, inv(16)(p13.1;q22) · acute myeloid leukemia, t(16;16)(p13.1;q22) · acute promyelocytic leukemia · adenocarcinoma · adult acute lymphoblastic leukemia · adult hepatocellular carcinoma · atypical chronic myeloid leukemia, BCR-ABL1 negative · blast phase chronic myelogenous leukemia, BCR-ABL1 positive · borderline epithelial tumor of ovary · brain glioblastoma · breast adenocarcinoma · Brenner tumor · castration-resistant prostate carcinoma · central nervous system non-hodgkin lymphoma · chronic myeloid leukemia · chronic myelomonocytic leukemia · diffuse large B-cell lymphoma germinal center B-cell type · enteropathy-associated T-cell lymphoma · extranodal nasal NK/T cell lymphoma · fallopian tube carcinoma · hepatosplenic T-cell lymphoma · infiltrating bladder urothelial carcinoma sarcomatoid variant · leukemia, myeloid, accelerated-phase · localized chondrosarcoma · malignant epithelial tumor of ovary · monomorphic epitheliotropic intestinal T-cell lymphoma · mycosis fungoides · myeloproliferative neoplasm, unclassifiable · Nodal T-follicular helper cell lymphoma, follicular type · ovarian clear cell cystadenocarcinoma · ovarian endometrioid adenocarcinoma · ovarian mucinous cystadenocarcinoma · ovarian serous cystadenocarcinoma · primary cutaneous aggressive epidermotropic CD8+ T-cell lymphoma · primary cutaneous gamma-delta t-cell lymphoma · primary myelofibrosis · refractory malignant neoplasm · sarcomatoid mesothelioma · small cell carcinoma · small cell lung carcinoma · small intestine lymphoma · soft tissue sarcoma · subcutaneous panniculitis-like T-cell lymphoma · therapy related acute myeloid leukemia and myelodysplastic syndrome · undifferentiated ovarian carcinoma · urinary bladder cancer · uveal melanoma
Investigated by
National Cancer Institute (NCI) · Valerio Therapeutics · Acrotech Biopharma Inc. · Spectrum Pharmaceuticals, Inc · Axis Clinicals Limited · University of Utah
+27 more · M.D. Anderson Cancer Center · Pfizer · Axis Clinical Trials · Bispebjerg Hospital · Bristol-Myers Squibb · City of Hope Medical Center · Copenhagen University Hospital at Herlev · Emory University · Gynecologic Oncology Group · H. Lee Moffitt Cancer Center and Research Institute · Herlev Hospital · Holy Cross Hospital, Florida · Johns Hopkins University · Massachusetts General Hospital · Massey Cancer Center · Mayo Clinic · National Comprehensive Cancer Network · National Institute of Neurological Disorders and Stroke (NINDS) · National Institutes of Health (NIH) · Novartis · Roche Pharma AG · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University of Arizona · University of Miami · University of Michigan Rogel Cancer Center · Virginia Commonwealth University · Yale University

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) BELEODAQ 2014-07-03 fda.gov

Trials 54 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 127 trials
Phase 1 NCT07691450 Jan 2027 → Nov 2029 expected Nodal T-follicular helper cell lymphoma, follicular type, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma +6 City of Hope Medical Center Not yet recruiting No outcome recorded
Phase 1 NCT05627245 Mar 2023 → Sep 2026 expected diffuse large B-cell lymphoma germinal center B-cell type, follicular lymphoma, primary cutaneous T-cell lymphoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1 NCT05154994 Jan 2022 → Aug 2026 overdue infiltrating bladder urothelial carcinoma sarcomatoid variant University of Utah Active not recruiting No outcome recorded
Phase 1 NCT04315233 May 2021 → Jun 2025 overdue breast cancer, ovarian carcinoma University of Utah Recruiting No outcome recorded
Phase 1 NCT04703920 Mar 2021 → Dec 2024 breast cancer, castration-resistant prostate carcinoma, ovarian carcinoma, pancreatic adenocarcinoma University of Michigan Rogel Cancer Center Completed No outcome recorded
Phase 1 NCT04315155 Oct 2020 → Sep 2023 adenocarcinoma University of Utah Withdrawn No outcome recorded
Phase 1 NCT04184869 Aug 2019 → Dec 2022 cancer, hematopoietic and lymphoid cell neoplasm Acrotech Biopharma Inc. Completed No outcome recorded
Phase 1 NCT03772925 Jun 2019 → Sep 2022 acute myeloid leukemia, myelodysplastic syndrome National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1 NCT03432741 Mar 2018 → Aug 2022 Hodgkins lymphoma, breast adenocarcinoma, mycosis fungoides, nodal marginal zone B-cell lymphoma Mayo Clinic Terminated No outcome recorded
Phase 1 NCT02875002 Oct 2016 → Mar 2018 lymphoma Yale University Withdrawn No outcome recorded
Phase 1/29 trials
Phase 1/2 NCT02701673 Jun 2016 → Jun 2019 lymphoma M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1/2 NCT01310244 Dec 2010 → Aug 2015 non-small cell lung carcinoma Acrotech Biopharma Inc. Completed No outcome recorded
Phase 1/2 NCT01188707 Oct 2010 → Jun 2011 non-small cell lung carcinoma Herlev Hospital Terminated No outcome recorded
Phase 1/2 NCT01090830 Apr 2010 → Feb 2012 non-small cell lung carcinoma Holy Cross Hospital, Florida Terminated No outcome recorded
Phase 1/2 NCT01100944 Mar 2010 → Oct 2015 thymic carcinoma, thymoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1/2 NCT00878722 Aug 2007 → May 2009 acute myeloid leukemia Valerio Therapeutics Completed No outcome recorded
Phase 1/2 NCT00878800 Dec 2006 → Oct 2012 soft tissue sarcoma Valerio Therapeutics Completed No outcome recorded
Phase 1/2 NCT00321594 May 2006 → Aug 2010 adult hepatocellular carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT00421889 Aug 2005 → Feb 2009 fallopian tube cancer, malignant epithelial tumor of ovary, urinary bladder cancer Valerio Therapeutics Completed No outcome recorded
Phase 218 trials
Phase 2 NCT06406465 Jul 2026 → Jul 2027 expected small cell carcinoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2 NCT05170334 Dec 2021 → Dec 2025 overdue uveal melanoma H. Lee Moffitt Cancer Center and Research Institute Active not recruiting No outcome recorded
Phase 2 NCT04340843 Sep 2020 → Feb 2024 overdue localized chondrosarcoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 2 NCT02737046 Dec 2016 → Dec 2024 adult T-cell leukemia/lymphoma University of Miami Completed No outcome recorded
Phase 2 NCT02137759 May 2014 → Aug 2023 brain glioblastoma Emory University Unknown No outcome recorded
Phase 2 NCT01686165 Aug 2012 → Feb 2016 anaplastic large cell lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma University of Arizona Completed No outcome recorded
Phase 2 NCT00993616 Dec 2009 → Jul 2012 Brenner tumor, fallopian tube cancer, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma +4 National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00873119 Feb 2009 → Dec 2012 cancer of unknown primary site Valerio Therapeutics Completed No outcome recorded
Phase 2 NCT00865969 Dec 2008 → Nov 2013 peripheral T-cell lymphoma, not otherwise specified Spectrum Pharmaceuticals, Inc Completed No outcome recorded
Phase 2 NCT00589290 Dec 2007 → Jul 2013 thymic carcinoma, thymoma National Cancer Institute (NCI) Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT04747236 Comparator Feb 2021 → Jun 2028 expected University of Virginia Recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT06561048 Comparator Oct 2024 → Nov 2027 expected Nodal T-follicular helper cell lymphoma, follicular type, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma, not otherwise specified Corvus Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 3 NCT06072131 Comparator Oct 2023 → Jul 2030 expected peripheral T-cell lymphoma, not otherwise specified Acrotech Biopharma Inc. Recruiting No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 60 sources stand behind the page.

FieldValueCited text
Known as Belinostat Belinostat, N-hydroxy-3-(phenylsulphamoylphenyl) acrylamide, is a hydroxamic acid deacetylase inhibitor that is able to inhibit both histone deacetylase inhibitors (HDAC) Class...” NCT01100944
52

NCT07691450

NCT00865969

NCT00348985

NCT04315155

NCT00357032

NCT01188707

NCT02381548

NCT00274651

NCT02137759

NCT01310244

NCT00421889

NCT05154994

NCT00413322

NCT00993616

NCT01686165

NCT05627245

NCT00303953

NCT05170334

NCT06561048

NCT00357162

NCT02142530

NCT00926640

NCT01317927

NCT02875002

NCT04340843

NCT02737046

NCT00354185

NCT03772925

NCT00589290

NCT01273155

NCT04703920

NCT04315233

NCT00351975

NCT01090830

NCT04184869

NCT00321594

NCT01583777

NCT02532192

NCT06072131

NCT00334789

NCT00301756

NCT00365053

NCT06406465

NCT04747236

NCT00413075

NCT00873119

NCT02701673

NCT02679131

NCT01075425

NCT02680795

NCT01839097

NCT03432741

Known as Beleodaq “Belinostat (Beleodaq, Spectrum Pharmaceuticals) is a histone deacetylase inhibitor (HDACi) approved for use in relapsed or refractory peripheral T-cell lymphoma (PTCL).” PMID 26921086 Jun 2016
Known as NSC-726630 ChEMBL registry synonym — accepted as the source's own label CHEMBL408513
Known as PDX101 “Belinostat (PDX101)” NCT00589290
Known as PX-105684 ChEMBL registry synonym — accepted as the source's own label CHEMBL408513
Known as PXD-101 “A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies” NCT01100944
7

“Establish the efficacy and safety of PXD101 (belinostat) in patients with myelodysplastic syndromes that progressed after or is ineligible for azacitidine treatment.” NCT00357162

“Phase I Study of Belinostat (PXD-101) and Velcade (Bortezomib) in Relapsed or Refractory Acute Leukemia/ Myelodysplastic Syndrome” NCT01075425

“A Phase II Exploratory Study of PXD-101 (Belinostat) Followed by Zevalin in ” NCT01686165

NCT00878800

NCT00878722

NCT00131261

NCT00431340

Known as PXD101 (Belinostat) PXD101 (Belinostat)NCT00878800
1

“PXD101, Belinostat” NCT00873119

Action Inhibit “PXD101 is a new, potent histone deacetylase (HDAC) inhibitor.” NCT00131261
Modality Small molecule CHEMBL408513
Route Intravenous “1000 mg/m(2) intravenously ×5 d of a 21-d cycle” PMID 25404094 Nov 2014