Literature DB >> 27250934

Lessons Learned: Dose Selection of Small Molecule-Targeted Oncology Drugs.

Julie M Bullock1, Atiqur Rahman2, Qi Liu3.   

Abstract

Evaluation of dose plays a critical role in a successful oncology development program. Typically for oncology agents, the first-in-man phase I dose-escalation trials are conducted to determine a maximum tolerated dose (MTD). This MTD is taken forward into subsequent trials to establish the safety and efficacy of the drug product. Although this approach was appropriate historically for cytotoxics, the application of MTD as the recommend phase II dose has been problematic for the newer small molecule-targeted oncology agents. Promising alternative approaches using dose and exposure exploration, including lessons learned from recent targeted oncology agent development and approvals, are summarized and discussed. Clin Cancer Res; 22(11); 2630-8. ©2016 AACR SEE ALL ARTICLES IN THIS CCR FOCUS SECTION, "NEW APPROACHES FOR OPTIMIZING DOSING OF ANTICANCER AGENTS". ©2016 American Association for Cancer Research.

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Year:  2016        PMID： 27250934     DOI： 10.1158/1078-0432.CCR-15-2646

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


  17 in total

1.  FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia.

Authors:  Kelly J Norsworthy; Chia-Wen Ko; Jee Eun Lee; Jiang Liu; Christy S John; Donna Przepiorka; Ann T Farrell; Richard Pazdur
Journal:  Oncologist       Date:  2018-04-12

Review 2.  Individualized dosing of oral targeted therapies in oncology is crucial in the era of precision medicine.

Authors:  Stefanie L Groenland; Ron H J Mathijssen; Jos H Beijnen; Alwin D R Huitema; Neeltje Steeghs
Journal:  Eur J Clin Pharmacol       Date:  2019-06-07       Impact factor: 2.953

3.  Molecular Pharmacodynamics-Guided Scheduling of Biologically Effective Doses: A Drug Development Paradigm Applied to MET Tyrosine Kinase Inhibitors.

Authors:  Apurva K Srivastava; Melinda G Hollingshead; Jeevan Prasaad Govindharajulu; Joseph M Covey; Dane Liston; Melanie A Simpson; James O Peggins; Donald P Bottaro; John J Wright; Robert J Kinders; James H Doroshow; Ralph E Parchment
Journal:  Mol Cancer Ther       Date:  2018-02-14       Impact factor: 6.261

4.  Precision Dosing of Targeted Therapies Is Ready for Prime Time.

Authors:  Neeltje Steeghs; Alwin D R Huitema; Stefanie L Groenland; Remy B Verheijen; Markus Joerger; Ron H J Mathijssen; Alex Sparreboom; Jos H Beijnen; Jan H Beumer
Journal:  Clin Cancer Res       Date:  2021-09-21       Impact factor: 12.531

5.  Designing phase I oncology dose escalation using dose-exposure-toxicity models as a complementary approach to model-based dose-toxicity models.

Authors:  Kristyn Pantoja; Shankar Lanke; Alain Munafo; Anja Victor; Christina Habermehl; Armin Schueler; Karthik Venkatakrishnan; Pascal Girard; Kosalaram Goteti
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6.  Enhanced oral bioavailability and antitumor therapeutic efficacy of sorafenib administered in core-shell protein nanoparticle.

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Journal:  Drug Deliv Transl Res       Date:  2022-06-09       Impact factor: 5.671

Review 7.  Anti-cancer drug combinations approved by US FDA from 2011 to 2021: main design features of clinical trials and role of pharmacokinetics.

Authors:  Salvador Fudio; Alvaro Sellers; Laura Pérez Ramos; Beatriz Gil-Alberdi; Ali Zeaiter; Mikel Urroz; Antonio Carcas; Rubin Lubomirov
Journal:  Cancer Chemother Pharmacol       Date:  2022-08-27       Impact factor: 3.288

8.  Safety and efficacy of lenvatinib by starting dose based on body weight in patients with unresectable hepatocellular carcinoma in REFLECT.

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Journal:  J Gastroenterol       Date:  2021-05-04       Impact factor: 7.527

9.  Targeted drug delivery strategies for precision medicines.

Authors:  Mandana T Manzari; Yosi Shamay; Hiroto Kiguchi; Neal Rosen; Maurizio Scaltriti; Daniel A Heller
Journal:  Nat Rev Mater       Date:  2021-02-02       Impact factor: 66.308

Review 10.  Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development.

Authors:  Stephanie Faucette; Santosh Wagh; Ashit Trivedi; Karthik Venkatakrishnan; Neeraj Gupta
Journal:  Clin Transl Sci       Date:  2017-12-19       Impact factor: 4.689
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