Current Status of Single-Agent Phase I Trials in Japan: Toward Globalization

被引:9
|
作者
Mizugaki, Hidenori [1 ]
Yamamoto, Noboru [1 ]
Fujiwara, Yutaka [1 ]
Nokihara, Hiroshi [1 ]
Yamada, Yasuhide [1 ]
Tamura, Tomohide [1 ]
机构
[1] Natl Canc Ctr, Tokyo 1040045, Japan
关键词
TYROSINE KINASE INHIBITOR; EVERY; 3; WEEKS; SUBEROYLANILIDE HYDROXAMIC ACID; ADVANCED SOLID TUMORS; DOSE-ESCALATION; MONOCLONAL-ANTIBODY; IXABEPILONE BMS-247550; LIPOSOMAL DOXORUBICIN; INTRAVENOUS-INFUSION; CAMPTOTHECIN ANALOG;
D O I
10.1200/JCO.2014.58.4953
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose In Japan, phase I trials, except first-in-human trials, are usually initiated from approximately 50% of the maximum-tolerated dose (MTD) or maximum administered dose (MAD) determined during the initial phase I trials in North America and Europe (the West). However, the key findings of phase I trials in Japan and the West, such as dose-limiting toxicity (DLT) profiles and MTD or MAD levels, have not been compared. Patients and Methods We retrospectively analyzed data for patients enrolled onto single-agent phase I trials at the National Cancer Center Hospital between 1995 and 2012. DLT profiles, MTDs, and MADs of single-agent phase I trials in Japan were compared with those from trials in the West that were obtained from the literature. Results A total of 777 patients were enrolled onto 54 single-agent phase I trials, including five first-in-human trials. DLTs were observed in 11.1% of the patients. Importantly, 66.4% of the DLTs were observed within a dose range (80% to 120%) similar to those reported for the trials in the West. The majority of MTDs or MADs could be considered similar between patients, and 80.3% of the drugs had similar MTDs or MADs in the West. Conclusion The toxicity profiles of single-agent phase I agents determined from trials conducted in Japan were comparable to those obtained from trials in the West. We believe that phase I trials in Japan could be conducted over timelines similar to those in the West, allowing for global or parallel phase I clinical trials. (C) 2015 by American Society of Clinical Oncology
引用
收藏
页码:2051 / U100
页数:13
相关论文
共 50 条
  • [31] CHEMOTHERAPY OF DIFFUSE MALIGNANT MESOTHELIOMA - PHASE-II TRIALS OF SINGLE-AGENT 5-FLUOROURACIL AND ADRIAMYCIN
    HARVEY, VJ
    SLEVIN, ML
    PONDER, BAJ
    BLACKSHAW, AJ
    WRIGLEY, PFM
    CANCER, 1984, 54 (06) : 961 - 964
  • [32] SINGLE-AGENT CARBOPLATIN FOR STAGE I SEMINOMA OF THE TESTIS: A SINGLE INSTITUTION EXPERIENCE
    Decatris, M. P.
    Kitsios, P.
    ANNALS OF ONCOLOGY, 2008, 19 : 203 - 203
  • [33] Phase II single-agent studies in elderly cancer patients
    Monfardini, S
    Lonardi, S
    TUMORI, 2002, 88 (01) : S13 - S14
  • [34] Phase II study of single-agent nivolumab in patients with myelofibrosis
    Abou Dalle, Iman
    Kantarjian, Hagop
    Daver, Naval
    Masarova, Lucia
    Pemmaraju, Naveen
    Bose, Prithivaj
    Garcia-Manero, Guillermo
    Verstovsek, Srdan
    ANNALS OF HEMATOLOGY, 2021, 100 (12) : 2957 - 2960
  • [35] Adverse Events During Single-Agent Phase of Venetoclax Therapy
    Parodi, Ginevra
    Habib, Sabrina
    Marks, Sasha
    Lofaro, Thomas
    CLINICAL LYMPHOMA MYELOMA & LEUKEMIA, 2024, 24 : S358 - S358
  • [36] Phase II study of single-agent nivolumab in patients with myelofibrosis
    Iman Abou Dalle
    Hagop Kantarjian
    Naval Daver
    Lucia Masarova
    Naveen Pemmaraju
    Prithivaj Bose
    Guillermo Garcia-Manero
    Srdan Verstovsek
    Annals of Hematology, 2021, 100 : 2957 - 2960
  • [37] Revisiting Risk and Benefit in Early Oncology Trials in the Era of Precision Medicine: A Systematic Review and Meta-Analysis of Phase I Trials of Targeted Single-Agent Anticancer Therapies
    Mackley, Michael P.
    Fernandez, Nicholas R.
    Fletcher, Benjamin
    Woolcott, Christy G.
    Fernandez, Conrad, V
    JCO PRECISION ONCOLOGY, 2021, 5 : 17 - 26
  • [38] Safety profile of single-agent carfilzomib in patients with relapsed or refractory multiple myeloma from 4 phase ll trials
    Siegel, D.
    Martin, T.
    Nooka, A.
    Harvey, R. D.
    Vij, R.
    Niesvizky, R.
    Badros, A. Z.
    Jagannath, S.
    McCulloch, L.
    Rajangam, K.
    Lenial, S.
    ONKOLOGIE, 2013, 36 : 39 - 40
  • [39] Late relapse of stage I seminoma following single-agent carboplatin
    Raj, S.
    Williams, M. V.
    Dixon, A. K.
    Robson, J.
    Mazhar, D.
    ONCOLOGY, 2007, 73 (5-6) : 419 - 421
  • [40] Safety profile of single-agent carfilzomib in patients with relapsed or refractory multiple myeloma from 4 phase 2 trials
    Siegel, D. S.
    Martin, T.
    Nooka, A.
    Harvey, R. D.
    Vij, R.
    Niesvizky, R.
    Badros, A. Z.
    Jagannath, S.
    McCulloch, L.
    Rajangam, K.
    Lonial, S.
    BRITISH JOURNAL OF HAEMATOLOGY, 2013, 161 : 20 - 20