Oncologic phase 0 trials incorporating clinical pharmacodynamics: From concept to patient

Clinical Cancer Research

Volumn 14, Issue 12, 2008, Pages 3658-3663

  Doroshow, James H ^a   Parchment, Ralph E ^b  

^a NATIONAL CANCER INSTITUTE   (United States)

^b SAIC FREDERICK INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ARTICLE; CLINICAL TRIAL; DRUG INDUSTRY; DRUG MECHANISM; DRUG TARGETING; EARLY INTERVENTION; EXPLORATORY RESEARCH; FOOD AND DRUG ADMINISTRATION; HUMAN; LABORATORY TEST; MOLECULAR IMAGING; PHARMACODYNAMICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; STANDARDIZATION; VALIDATION PROCESS; CONCEPT FORMATION; DIAGNOSIS, MEASUREMENT AND ANALYSIS; DRUG DELIVERY SYSTEM; LABORATORY DIAGNOSIS; METHODOLOGY; STANDARD;

ANTINEOPLASTIC AGENT;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; CONCEPT FORMATION; DRUG DELIVERY SYSTEMS; HUMANS; LABORATORY TECHNIQUES AND PROCEDURES; SPECIMEN HANDLING;

EID: 52449092892     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-07-4562     Document Type: Article

References (27)

1. Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004;3: 711 -5.
2. Johnson Jl, Decker S, Zaharevitz D, et al. Relation-ships between drug activity in NCI preclinical in vitro and in vivo models and early clinical trials. Br J Cancer 2001;84:1424-31.
3. Garber K. Sugen falls as casualty of Pfizer-Pharmacia merger. Nat Biotechnol 2007;7:722-3.
4. Park JW, Kerbel RS, Kelloff GJ, et al. Rationale for biomarkers and surrogate end points in mechanism- driven oncology drug development. Clin Cancer Res 2004;10:3885-96.
5. Goldin A, Carter SK. Screening and evaluation of antitumor agents. In: Holland JF, Frei III E, editors. Cancer medicine. Philadelphia: Lea & Febiger; 1973. p. 605-28.
6. Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collins J, Christian MC. Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst 1997:89:1138-47.
7. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 1990;46:33-48.
8. Parulekar WR, Eisenhauer EA. Phase I trial design for solid tumor studies of targeted, non-cytotoxic agents: theory and practice. J Natl Cancer Inst 2004;96:990-7.
9. Goulart BH, Clark JW, Pien HH, Roberts TG, Finkelstein SN, Chabner BA. Trends in the use and role of biomarkers in phase I oncology trials. Clin Cancer Res 2007;13:6719-26.
10. Kummar S, Gutierrez M, Doroshow JH, MurgoAJ. Drug development in oncology: classical cytotoxics and molecularly targeted agents. Br J Clin Pharmacol 2006;62:15-26.
11. Tomaszewski JE, Doroshow JH. Preclinical development of molecularly targeted agents in oncology. In: Kaufman HL, Wadler S, Antman K, editors. Cancer drug discovery and development: molecular targeting in oncology. Totowa (NJ): Humana Press; 2008. p.703-18.
12. Workman P, Aboagye EO, Chung YL, et al. Minimally invasive pharmacokinetic and pharmacodynamic technologies in hypothesis-testing clinicaltrials of innovative therapies. J Natl Cancer Inst 2006;98:580-98.
13. Kummar S, Kinders R, Rubinstein L, et al. Compressing drug development timelines in oncology using phase '0' trials. Nat Rev Cancer 2007;7: 131-9.
14. Marchetti S, Schellens JH. The impact of FDA and EMEA guidelines on drug development in relation to phase 0 trials. Br J Cancer 2007;97:577-81.
15. Sparreboom A. Unexplored pharmacokinetic op portunities with microdosing in oncology. Clin Cancer Res 2007;13:4033-4.
16. Kimmelman J. Ethics at phase 0: clarifying the issues. J Law Med Ethics 2007;35:727-33.
17. Hill TP. Phase 0 trials: are they ethically challenged? Clin Cancer Res 2007;13:783-4.
18. Kummar S, Kinders R, Gutierrez M, et al. Inhibition of poly(ADP-ribose) polymerase (PARP) by ABT-888 in patients with advanced malignancies: results of a phase 0 trial. J Clin Oncol 2007;25:142s.
19. Robinson WT. Innovative early development regulatory approaches: ExpIND, ExpCTA, Microdosing. Clin Pharmacol Ther 2008;83:358-60.
20. Calvert AH, Plummer R. The development of phase I cancer trial methodologies: the use of pharmacokinet ic and pharmacodynamic end points sets the scene for phase 0 cancer clinical trials. Clin Cancer Res 2008;14:3664-9.
21. Jacobson-Kram D, Mills G. Leveraging exploratory investigational new drug studies to accelerate drug development. Clin Cancer Res 2008;14:3670-4.
22. Murgo AJ, Kummar S, Rubinstein L, et al. Designing phase 0 cancer clinical trials. Clin Cancer Res 2008; 14:3675-82.
23. Eliopoulos H, GirandaV, Carr R.Tiehen R, Leahy T, Gordon G. Phase 0 trials: an industry perspective. Clin Cancer Res 2008;14:3683-8.
24. Gutierrez M, Collyar D. Patient perspectives on phase 0 clinical trials. Clin Cancer Res 2008:14: 3689-91.
25. Abdoler E.Taylor H.Wendler D.The ethics of phase 0 oncology trials. Clin Cancer Res 2008;14:3692-7.
26. Kinders RJ, Hollingshead M, Parchment RE, et al. Preclinical modeling of a phase 0 clinical trial protocol. J Clin Oncol 2007;25:616s.
27. Baker AF, DragovichT, Ihle NT, Williams R, Fenoglio- Preiser CM, Powis G. Stability of phospho-protein as a biological marker of tumor signaling. Clin Cancer Res 2005;11:4338-40.