Pharmacokinetic / Pharmacodynamic (PK/PD) Simulations Guide Selection of the Dose for Administration of Efgartigimod Subcutaneously in a Phase 3 Clinical Trial in Patients with Primary Immune Thrombocytopenia

被引：0
|
作者：
Ghanima, Waleed [1 ,2 ,3 ]
McDonald, Vickie [4 ]
Jain, Shivi [5 ]
Carpenedo, Monica [6 ]
Oliva, Esther N. [7 ]
Hultberg, Anna [8 ]
Gandini, Domenica [8 ]
Hofman, Erik [8 ]
Van Bragt, Tonke [8 ]
Parys, Wim [8 ]
van Hoorick, Benjamin [8 ]
Miyakawa, Yoshitaka [9 ]
Broome, Catherine M. [10 ]
机构：
[1] Kalnes, Ostfold Hosp Trust, Dept Med Hematol Oncol & Res, Gralum, Norway
[2] Oslo Univ Hosp, Dept Hematol, Oslo, Norway
[3] Univ Oslo, Inst Clin Med, Oslo, Norway
[4] Barts Hlth NHS Trust, London, England
[5] Rush Univ, Med Ctr, Div Hematol Oncol Cell Therapy, Chicago, IL USA
[6] ASST Osped San Gerardo Monza, Monza, Italy
[7] Grande Osped Metropolitano, Haematol Unit, Reggio Di Calabria, Italy
[8] Argenx, Ghent, Belgium
[9] Saitama Med Univ Hosp, Saitama, Japan
[10] Georgetown Univ, Washington, DC USA
来源：
BLOOD | 2021年 / 138卷
关键词：
D O I：
10.1182/blood-2021-153261
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
3165
引用
收藏
页数：5
相关论文
共 50 条
  • [41] Preliminary Clinical, Pharmacokinetic (PK) and Pharmacodynamic (PD) Results of the Safety Run-In Part of a Phase II Trial of Orally Available MEK-Inhibitor MSC1936369 in Patients (Pts) with Advanced Hematological Malignancies (HM)
    Ravandi, Farhad
    Pigneux, Arnaud
    DeAngelo, Daniel J.
    Dombret, Herve
    Delaunay, Jacques
    Thomas, Xavier
    Kadia, Tapan
    Luepfert, Christian
    Asatiani, Ekaterine
    Donica, Margarita
    Kantarjian, Hagop M.
    Smith, B. Douglas
    [J]. BLOOD, 2011, 118 (21) : 675 - 676
  • [42] A Phase 2 Open-Label, Multicenter, Dose Optimization Clinical Study of the Safety, Tolerability, and Pharmacokinetic (PK) and Pharmacodynamic (PD) Profiles of Cfi-400945 As a Single Agent or in Combination with Azacitidine or Decitabine in Patients with Acute Myeloid Leukemia
    Jonas, Brian A.
    Bixby, Dale L.
    Brandwein, Joseph M.
    Yee, Karen W. L.
    Murphy, Tracy
    Minden, Mark D.
    Michelson, Glenn C.
    Bray, Mark R.
    Roberts-Thomson, Emily Elizabeth
    Borthakur, Gautam
    [J]. BLOOD, 2020, 136
  • [43] A phase I, dose escalation (DE), pharmacokinetic (PK), and pharmacodynamic (PD) study of two schedules of OSI-930, an oral tyrosine kinase inhibitor (TKI), in patients (pts) with advanced solid tumors
    Lal, R.
    Camidge, D. R.
    George, S.
    Demetri, G. D.
    Eckhardt, S. G.
    Stephens, A.
    Chick, J.
    Boinpally, R.
    Kaye, S. B.
    Scurr, M.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (15)
  • [44] Phase 1 pharmacokinetic (PK) and pharmacodynamic(PD) evaluation of SF1126 a vascular targeted pan phosphoinositide 3-kinase (PI3K) inhibitor in patients with solid tumors
    Schwertschlag, U. S.
    Chiorean, E. G.
    Anthony, S. P.
    Sweeney, C. J.
    Borad, M. J.
    Von Hoff, D. D.
    Garlich, J. R.
    Shelton, C. F.
    Ramanathan, R. K.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (15)
  • [45] A Phase 1 dose-escalation, pharmacokinetic (PK) and pharmacodynamic (PD) evaluation of intravenous LY2275796 (LY), an elF-4E antisense oligonucleotide (ASO) in patients with advanced solid tumors
    Simon, G. R.
    Fishman, M.
    Dellaportas, A. M.
    Sullivan, D.
    Brail, L. H.
    Andre, V.
    Callies, S.
    Aytac, U.
    Hong, D.
    Oh, Y.
    [J]. EJC SUPPLEMENTS, 2008, 6 (12): : 125 - 125
  • [46] Pharmacokinetic (PK) - pharmacodynamic (PD) study of gemcitabine (G) in a randomised phase II trial of carboplatin (C) combined with G at standard rate infusion or fixed dose rate infusion in patients with advanced non-small-cell lung cancer (NSCLC).
    Soo, RA
    Lim, HL
    Wang, LZ
    Tham, LS
    Soong, R
    Lee, HS
    Liang, S
    Lee, SC
    Boyer, M
    Goh, BC
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (16) : 141S - 141S
  • [47] Prasugrel versus clopidogrel in Asian patients with acute coronary syndromes: design and rationale of a multi-dose, pharmacodynamic, phase 3 clinical trial
    Ge, Junbo
    Zhu, Junren
    Hong, Bum-Kee
    Boonbaichaiyapruck, Sarana
    Goh, Yew Seong
    Hou, Charles Jia-Yin
    Pinton, Philippe
    [J]. CURRENT MEDICAL RESEARCH AND OPINION, 2010, 26 (09) : 2077 - 2085
  • [48] PHARMACOKINETIC/PHARMACODYNAMIC (PK/PD) EVALUATION OF AG-221, A POTENT MUTANT IDH2 INHIBITOR, FROM A PHASE 1 TRIAL OF PATIENTS WITH IDH2-MUTATION POSITIVE HEMATOLOGIC MALIGNANCIES
    Fan, B.
    Chen, Y.
    Wang, F.
    Yen, K.
    Utley, L.
    Almon, C.
    Straley, K.
    Attar, E.
    Bowden, C.
    Biller, S.
    Agresta, S.
    Yang, H.
    [J]. HAEMATOLOGICA, 2015, 100 : 379 - 379
  • [49] A phase I, pharmacokinetic (PK) and pharmacodynamic (PD) study of MDX214, a novel immune-mediated mechanism agent targeting the epithelial growth factor receptor (EGFR), in patients with advanced solid tumors.
    Mita, C. A.
    Papadopoulos, K.
    Mita, M. M.
    Ricart, A.
    Sarantopoulos, J.
    Berg, K.
    Uritz, B.
    Levy, E.
    Lowy, I.
    Tolcher, A. W.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2006, 24 (18) : 105S - 105S
  • [50] A pharmacokinetic (PK) and pharmacodynamic (PD) biomarker-driven phase I study of intermittent, low dose intensity schedules of the dual MEK/RAF inhibitor, RO5126766 (RO) in patients (pts) with advanced solid tumors
    Luken, Maria Jose de Miguel
    Roda, Desamparados
    Lopez, Raquel Perez
    Jimenez, Begona
    Hassam, Hasina
    Sathiyayogan, Nitharsan
    Parmar, Mona
    Turner, Alison Joanne
    Hall, Emma
    Tunariu, Nina
    Molife, L. Rhoda
    Yap, Timothy Anthony
    De Bono, Johann Sebastian
    Banerji, Udai
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2015, 33 (15)
12345