Phase 1 study of belinostat and adavosertib in patients with relapsed or refractory myeloid malignancies

Do K, Doroshow JH, Kummar S (2013) Wee1 kinase as a target for cancer therapy. Cell Cycle 12(19):3159–3164

Article  CAS  PubMed  PubMed Central  Google Scholar 

Porter CC, Kim J, Fosmire S, Gearheart CM, van Linden A, Baturin D et al (2012) Integrated genomic analyses identify WEE1 as a critical mediator of cell fate and a novel therapeutic target in acute myeloid leukemia. Leukemia 26(6):1266–1276

Article  CAS  PubMed  PubMed Central  Google Scholar 

Cancer Genome Atlas Research N, Ley TJ, Miller C, Ding L, Raphael BJ, Mungall AJ et al (2013) Genomic and epigenomic landscapes of adult de novo acute myeloid leukemia. N Engl J Med 368(22):2059–2074

Article  Google Scholar 

Seedhouse C, Grundy M, Shang S, Ronan J, Pimblett H, Russell N et al (2009) Impaired S-phase arrest in acute myeloid leukemia cells with a FLT3 internal tandem duplication treated with clofarabine. Clin Cancer Res 15(23):7291–7298

Article  CAS  PubMed  Google Scholar 

Kirschbaum MH, Foon KA, Frankel P, Ruel C, Pulone B, Tuscano JM et al (2014) A phase 2 study of belinostat (PXD101) in patients with relapsed or refractory acute myeloid leukemia or patients over the age of 60 with newly diagnosed acute myeloid leukemia: a California Cancer Consortium Study. Leuk Lymphoma 55(10):2301–2304

Article  CAS  PubMed  PubMed Central  Google Scholar 

Holkova B, Shafer D, Yazbeck V, Dave S, Bose P, Tombes MB et al (2021) Phase 1 study of belinostat (PXD-101) and bortezomib (Velcade, PS-341) in patients with relapsed or refractory acute leukemia and myelodysplastic syndrome. Leuk Lymphoma 62(5):1187–1194

Article  CAS  PubMed  Google Scholar 

Leijen S, van Geel RM, Pavlick AC, Tibes R, Rosen L, Razak AR et al (2016) Phase I study evaluating WEE1 inhibitor AZD1775 as monotherapy and in combination with gemcitabine, cisplatin, or carboplatin in patients with advanced solid tumors. J Clin Oncol 34(36):4371–4380

Article  CAS  PubMed  PubMed Central  Google Scholar 

Li J, Wu J, Bao X, Honea N, Xie Y, Kim S et al (2017) Quantitative and mechanistic understanding of AZD1775 penetration across human blood-brain barrier in glioblastoma patients using an IVIVE-PBPK modeling approach. Clin Cancer Res 23(24):7454–7466

Article  CAS  PubMed  PubMed Central  Google Scholar 

Wang LZ, Ramirez J, Yeo W, Chan MY, Thuya WL, Lau JY et al (2013) Glucuronidation by UGT1A1 is the dominant pathway of the metabolic disposition of belinostat in liver cancer patients. PLoS ONE 8(1):e54522

Article  CAS  PubMed  PubMed Central  Google Scholar 

BELEODAQ® (belinostat) for injection, for intravenous use Prescribing Information. Acrotech Biopharma LLC. East Windsor, NJ. Revised Apr 2022

Dai Y, Chen S, Kmieciak M, Zhou L, Lin H, Pei XY et al (2013) The novel Chk1 inhibitor MK-8776 sensitizes human leukemia cells to HDAC inhibitors by targeting the intra-S checkpoint and DNA replication and repair. Mol Cancer Ther 12(6):878–889

Article  CAS  PubMed  PubMed Central  Google Scholar 

Zhou L, Zhang Y, Chen S, Kmieciak M, Leng Y, Lin H et al (2015) A regimen combining the Wee1 inhibitor AZD1775 with HDAC inhibitors targets human acute myeloid leukemia cells harboring various genetic mutations. Leukemia 29(4):807–818

Article  CAS  PubMed  Google Scholar 

Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T et al (2017) Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood 129(4):424–447

Article  PubMed  PubMed Central  Google Scholar 

Dohner H, Estey EH, Amadori S, Appelbaum FR, Buchner T, Burnett AK et al (2010) Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood 115(3):453–474

Article  PubMed  Google Scholar 

Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH et al (2003) Revised recommendations of the International Working Group for Diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol 21(24):4642–4649

Article  PubMed  Google Scholar 

Cheson BD, Greenberg PL, Bennett JM, Lowenberg B, Wijermans PW, Nimer SD et al (2006) Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood 108(2):419–425

Article  CAS  PubMed  Google Scholar 

Ito S, Ishida Y, Murai K, Kuriya S (2001) Flow cytometric analysis of aberrant antigen expression of blasts using CD45 blast gating for minimal residual disease in acute leukemia and high-risk myelodysplastic syndrome. Leuk Res 25(3):205–211

Article  CAS  PubMed  Google Scholar 

Kiesel BF, Parise RA, Tjornelund J, Christensen MK, Loza E, Tawbi H et al (2013) LC-MS/MS assay for the quantitation of the HDAC inhibitor belinostat and five major metabolites in human plasma. J Pharm Biomed Anal 81–82:89–98

Article  PubMed  Google Scholar 

de Bruijn P, Willems EW, Loos WJ, Verweij J, Sparreboom A (2004) Indirect determination of the irinotecan metabolite 7-ethyl-10-O-glucuronyl-camptothecin in human samples. Anal Biochem 328(1):84–86

Article  PubMed  Google Scholar 

U. S. Food and Drug Administration Center for Drug Evaluation and Research (2001) Guidance for industry bioanalytical method validation

Lassen U, Molife LR, Sorensen M, Engelholm SA, Vidal L, Sinha R et al (2010) A phase I study of the safety and pharmacokinetics of the histone deacetylase inhibitor belinostat administered in combination with carboplatin and/or paclitaxel in patients with solid tumours. Br J Cancer 103(1):12–17

Article  CAS  PubMed  PubMed Central  Google Scholar 

Agarwal N, McPherson JP, Bailey H, Gupta S, Werner TL, Reddy G et al (2016) A phase I clinical trial of the effect of belinostat on the pharmacokinetics and pharmacodynamics of warfarin. Cancer Chemother Pharmacol 77(2):299–308

Article  CAS  PubMed  Google Scholar 

Bailey H, McPherson JP, Bailey EB, Werner TL, Gupta S, Batten J et al (2016) A phase I study to determine the pharmacokinetics and urinary excretion of belinostat and metabolites in patients with advanced solid tumors. Cancer Chemother Pharmacol 78(5):1059–1071

Article  CAS  PubMed  Google Scholar 

Van Linden AA, Baturin D, Ford JB, Fosmire SP, Gardner L, Korch C et al (2013) Inhibition of Wee1 sensitizes cancer cells to antimetabolite chemotherapeutics in vitro and in vivo, independent of p53 functionality. Mol Cancer Ther 12(12):2675–2684

Article  PubMed  PubMed Central  Google Scholar 

Garcia TB, Snedeker JC, Baturin D, Gardner L, Fosmire SP, Zhou C et al (2017) A small-molecule inhibitor of WEE1, AZD1775, synergizes with olaparib by impairing homologous recombination and enhancing DNA damage and apoptosis in acute leukemia. Mol Cancer Ther 16(10):2058–2068

Article  CAS  PubMed  PubMed Central  Google Scholar 

Qi W, Zhang W, Edwards H, Chu R, Madlambayan GJ, Taub JW et al (2015) Synergistic anti-leukemic interactions between panobinostat and MK-1775 in acute myeloid leukemia ex vivo. Cancer Biol Ther 16(12):1784–1793

Article  CAS  PubMed  PubMed Central  Google Scholar 

Schlenk RF, Krauter J, Raffoux E, Kreuzer KA, Schaich M, Noens L et al (2018) Panobinostat monotherapy and combination therapy in patients with acute myeloid leukemia: results from two clinical trials. Haematologica 103(1):e25–e28

Article  CAS  PubMed  PubMed Central  Google Scholar 

Zhou L, Chen S, Zhang Y, Kmieciak M, Leng Y, Li L et al (2016) The NAE inhibitor pevonedistat interacts with the HDAC inhibitor belinostat to target AML cells by disrupting the DDR. Blood 127(18):2219–2230

Article  CAS  PubMed  PubMed Central  Google Scholar 

Morabito F, Voso MT, Hohaus S, Gentile M, Vigna E, Recchia AG et al (2016) Panobinostat for the treatment of acute myelogenous leukemia. Expert Opin Investig Drugs 25(9):1117–1131

Article  CAS  PubMed  Google Scholar 

Garcia-Manero G, Sekeres MA, Egyed M, Breccia M, Graux C, Cavenagh JD et al (2017) A phase 1b/2b multicenter study of oral panobinostat plus azacitidine in adults with MDS, CMML or AML with 30% blasts. Leukemia 31(12):2799–2806

Article  CAS  PubMed  PubMed Central  Google Scholar 

Abaza YM, Kadia TM, Jabbour EJ, Konopleva MY, Borthakur G, Ferrajoli A et al (2017) Phase 1 dose escalation multicenter trial of pracinostat alone and in combination with azacitidine in patients with advanced hematologic malignancies. Cancer 123(24):4851–4859

Article  CAS  PubMed  Google Scholar 

Xie C, Drenberg C, Edwards H, Caldwell JT, Chen W, Inaba H et al (2013) Panobinostat enhances cytarabine and daunorubicin sensitivities in AML cells through suppressing the expression of BRCA1, CHK1, and Rad51. PLoS ONE 8(11):e79106

Article  CAS  PubMed  PubMed Central  Google Scholar 

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