Impact of phase 1 expansion cohorts on probability of success in phase 2 and time-to-drug-approval: analysis of 385 new drugs in oncology

被引:1
|
作者
Bugano, D. [1 ]
Hess, K. [2 ]
Siu, L. L. [3 ]
Meric-Bernstam, F. [4 ]
Razak, A. R. A. [3 ]
Hong, D. S. [4 ]
机构
[1] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
[2] Univ Texas MD Anderson Canc Ctr, Dept Biostat, Div Quantitat Sci, Houston, TX 77030 USA
[3] Princess Margaret Canc Ctr, Drug Dev Program, Toronto, ON, Canada
[4] Univ Texas MD Anderson Canc Ctr, Dept Invest Canc Therapeut, Houston, TX 77030 USA
关键词
D O I
10.1016/S0959-8049(14)70363-6
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
237
引用
收藏
页码:79 / 80
页数:2
相关论文
共 7 条
  • [1] Use of Expansion Cohorts in Phase I Trials and Probability of Success in Phase II for 381 Anticancer Drugs
    Bugano, Diogo D. G.
    Hess, Kenneth
    Jardim, Denis L. F.
    Zer, Alona
    Meric-Bernstam, Funda
    Siu, Lillian L.
    Razak, Albiruni R. A.
    Hong, David S.
    CLINICAL CANCER RESEARCH, 2017, 23 (15) : 4020 - 4026
  • [2] Potential factors correlating to the PMDA’s decision to waive Japanese Phase 2 and 3 studies for oncology drugs New Drug Application in Japan
    Keitaro Nakajima
    Koji Chiba
    Hisao Tsubamoto
    Jaimie Walsh
    Laurie Strawn
    Toshio Suwa
    Investigational New Drugs, 2013, 31 : 1051 - 1055
  • [3] Potential factors correlating to the PMDA's decision to waive Japanese Phase 2 and 3 studies for oncology drugs New Drug Application in Japan
    Nakajima, Keitaro
    Chiba, Koji
    Tsubamoto, Hisao
    Walsh, Jaimie
    Strawn, Laurie
    Suwa, Toshio
    INVESTIGATIONAL NEW DRUGS, 2013, 31 (04) : 1051 - 1055
  • [4] Adherence to the Food and Drug Administration (FDA) guidance for the co-development of two or more investigational new drugs in phase 1/2 cancer trials
    Moyers, J. T.
    Nguyen, D.
    Hong, D. S.
    Dumbrava, E. E. Ileana
    Fu, S.
    Karp, D.
    Naing, A.
    Pant, S.
    Janku, F.
    Piha-Paul, S. A.
    Rodon, J.
    Subbiah, V.
    Tsimberidou, A. M.
    Meric-Bernstam, F.
    Yap, T. A.
    ANNALS OF ONCOLOGY, 2021, 32 : S1105 - S1106
  • [5] Safety and antitumor activity of nivolumab (nivo) in patients (pts) with advanced hepatocellular carcinoma (HCC): Interim analysis of dose-expansion cohorts from the phase 1/2 CheckMate-040 study
    Sangro, Bruno
    Melero, Ignacio
    Yau, Thomas Cheung
    Hsu, Chiun
    Kudo, Masatoshi
    Crocenzi, Todd S.
    Kim, Tae-You
    Choo, Supin
    Trojan, Jorg
    Meyer, Tim
    Kang, Yoon-Koo
    Anderson, Jeffrey
    Dela Cruz, Christine Marie
    Lang, Lixin
    Neely, Jaclyn
    El-Khoueiry, Anthony B.
    JOURNAL OF CLINICAL ONCOLOGY, 2016, 34 (15)
  • [6] Phase 1 Study of the Tissue Factor Targeting Antibody-Drug Conjugate XBOO2 in Patients with Advanced Solid Tumors (JEWEL-101): Design of Expansion Cohorts for Squamous Cell Carcinoma of the Head and Neck
    Ulahannan, S.
    Johnson, M.
    Weiss, M.
    Vandross, A.
    Vidal-Cardenas, S.
    Syed, M.
    Tolcher, A.
    INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2024, 118 (05): : E31 - E32
  • [7] Optimizing the dose of upifitamab rilsodotin (UpRi; XMT-1536), a NaPi2b-directed dolaflexin antibody drug conjugate (ADC): A post-hoc analysis of a phase 1b expansion study in ovarian cancer
    Monk, Bradley
    Concin, Nicole
    Richardson, Debra
    Ray-Coquard, Isabelle
    Pothuri, Bhavana
    Marth, Christian
    Bernardo, Patricia
    Burger, Robert
    Im, Ellie
    Aldairy, Wassim
    Coleman, Robert
    Mirza, Mansoor
    GYNECOLOGIC ONCOLOGY, 2022, 166 : S166 - S166