PHARMACOLOGY-GUIDED RULE-BASED ADAPTIVE DOSE ESCALATION IN FIRST-IN-HUMAN STUDIES.

被引：0
|
作者：
van Hoogdalem, E. [1 ]
Van Lersel, T. [1 ]
Winter, E. [2 ]
Constant, J. [3 ]
机构：
[1] PRA Hlth Sci, Groningen, Netherlands
[2] PRA Hlth Sci, Blue, PA USA
[3] PRA Hlth Sci, Victoria, BC, Canada
来源：
CLINICAL PHARMACOLOGY & THERAPEUTICS | 2020年 / 107卷
关键词：
D O I：
暂无
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
OII-001
引用
收藏
页码：S117 / S117
页数：1
相关论文
共 50 条
  • [41] First-in-human, phase I/IIa dose-escalation and safety study of balugrastim in breast cancer patients receiving myelosuppressive chemotherapy
    Noa Avisar
    Liat Adar
    Jason Bock
    Udo Müller
    David Shen
    Steve Barash
    Laurie Pukac
    Cancer Chemotherapy and Pharmacology, 2015, 75 : 929 - 939
  • [42] Autologous Macrophage Therapy for Liver Cirrhosis (MATCH): A First-in-Human, Phase 1, Single-Arm, Dose-Escalation Trial
    Moroni, Francesca
    Dwyer, Benjamin
    Glover, Alison
    Graham, Catriona
    Mcgowan, Neil
    Fraser, Alasdair
    Campbell, John
    Atkinson, Anne
    Mitchell, Donna
    Pass, Chloe
    Bailey, Laura
    Turner, Mark
    Hayes, Peter C.
    Fallowfield, Jonathan Andrew
    Forbes, Stuart J.
    HEPATOLOGY, 2018, 68 : 1127A - 1128A
  • [43] Local delivery of hrBMP4 as an anticancer therapy in patients with recurrent glioblastoma: a first-in-human phase 1 dose escalation trial
    Eelke M. Bos
    Elena Binda
    Iris S.C. Verploegh
    Eva Wembacher
    Daphna Hoefnagel
    Rutger K. Balvers
    Anne L. Korporaal
    Andrea Conidi
    Esther A. H. Warnert
    Nadia Trivieri
    Alberto Visioli
    Paola Zaccarini
    Laura Caiola
    Rogier van Wijck
    Peter van der Spek
    Danny Huylebroeck
    Sieger Leenstra
    Martine L.M. Lamfers
    Zvi Ram
    Manfred Westphal
    David Noske
    Federico Legnani
    Francesco DiMeco
    Angelo Luigi Vescovi
    Clemens M.F. Dirven
    Molecular Cancer, 22
  • [44] GDC-0810 Pharmacokinetics and Transporter-Mediated Drug Interaction Evaluation with an Endogenous Biomarker in the First-in-Human, Dose Escalation Study
    Cheung, Kit Wun Kathy
    Yoshida, Kenta
    Cheeti, Sravanthi
    Chen, Buyun
    Morley, Roland
    Chan, Iris T.
    Sahasranaman, Srikumar
    Liu, Lichuan
    DRUG METABOLISM AND DISPOSITION, 2019, 47 (09) : 966 - 973
  • [45] First-in-human dose escalation and food effect study of oral ONC206 in adults with recurrent primary CNS neoplasms.
    Theeler, Brett James
    Jung, Jinkyu
    Burton, Eric
    Leeper, Heather
    Wu, Jing
    Zaghloul, Kareem
    Ray-Chaudhury, Abhik
    Quezado, Martha
    Raffeld, Mark
    Yuan, Ying
    Aldape, Kenneth D.
    Penas-Prado, Marta
    Prabhu, Varun Vijay
    Stogniew, Martin
    Allen, Joshua E.
    Armstrong, Terri S.
    Gilbert, Mark R.
    JOURNAL OF CLINICAL ONCOLOGY, 2021, 39 (15)
  • [46] First-in-human dose escalation, safety, and PK study of a novel EFNA4-ADC in patients with advanced solid tumors.
    Hong, David S.
    Garrido-Laguna, Ignacio
    Krop, Ian E.
    Subbiah, Vivek
    Werner, Theresa Louise
    Cotter, Christine M.
    Hamilton, Erika Paige
    Velastegui, Karen
    Xuan, Dawei
    Bugarini, Roberto
    Gollerkeri, Ashwin
    Burris, Howard A.
    JOURNAL OF CLINICAL ONCOLOGY, 2015, 33 (15)
  • [47] A phase I, first-in-human, randomized dose-escalation study of anti-activated factor XII monoclonal antibody garadacimab
    McKenzie, Andrew
    Roberts, Anthony
    Malandkar, Sourabh
    Feuersenger, Henrike
    Panousis, Con
    Pawaskar, Dipti
    CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2022, 15 (03): : 626 - 637
  • [48] A phase I, first-in-human, dose escalation study of intravenous TK216 in patients with relapsed or refractory Ewing sarcoma.
    Federman, Noah
    Meyers, Paul A.
    Daw, Najat C.
    Toretsky, Jeffrey
    Breitmeyer, James Bradley
    Singh, Arun S.
    Miller, Landon L.
    Oltersdorf, Tilman
    Jezior, Deborah
    Jessen, Katayoun A.
    Lannutti, Brian
    Ludwig, Joseph A.
    JOURNAL OF CLINICAL ONCOLOGY, 2017, 35
  • [49] First-in-human, phase I/IIa dose-escalation and safety study of balugrastim in breast cancer patients receiving myelosuppressive chemotherapy
    Avisar, Noa
    Adar, Liat
    Bock, Jason
    Mueller, Udo
    Shen, David
    Barash, Steve
    Pukac, Laurie
    CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2015, 75 (05) : 929 - 939
  • [50] A First-in-Human Phase I Dose Escalation Study of IMM01, Sirpα Fc Protein in Patients with Relapsed or Refractory Lymphoma
    Qi, Junyuan
    Sun, Mingyuan
    Ji, Dongmei
    Zhou, Ping
    Xing, Shuning
    Huang, Cheng
    Lu, Qiying
    Tian, Wenzhi
    Qiu, Lugui
    BLOOD, 2022, 140 : 3651 - 3652
12345