Information needed to conduct first-in-human oncology trials in the United States: A view from a former fda medical reviewer

Clinical Cancer Research

Volumn 16, Issue 6, 2010, Pages 1719-1725

  Senderowicz, Adrian M ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADJUVANT CHEMOTHERAPY; ADVANCED CANCER; CANCER THERAPY; CHEMISTRY; CHEMOPROPHYLAXIS; DRUG APPROVAL; DRUG MANUFACTURE; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HUMAN; LAW; MEDICAL INFORMATION; MEDICAL RECORD REVIEW; METASTASIS; NONHUMAN; ONCOLOGY; PHARMACODYNAMICS; PHARMACOKINETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; TREATMENT INDICATION; UNITED STATES; VOLUNTEER;

ANIMALS; CLINICAL TRIALS AS TOPIC; DRUGS, INVESTIGATIONAL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; NEOPLASMS; TOXICITY TESTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77949663359     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-09-2766     Document Type: Review

References (24)

1. LoRusso PM, Boerner SA, Seymour LK. An overview of the optimal planning, design and conduct of phase I studies of new therapeutics. Clin Cancer Res 2010;16:1710-8.
2. Ivy SP, Siu L, Garrett-Mayer E, Rubinstein L. Approaches to phase 1 clinical trial design focused on safety, efficiency and selected patient populations: A report from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee. Clin Cancer Res 2010;16:1726-36.
3. Dancey JE, Dobbin KK, Groshen S, et al. Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents. Clin Cancer Res 2010;16:1745-55.
4. Forster MD, Saijo N, Seymour L, Calvert AH. Performing phase I clinical trials of anticancer agents: perspectives from within the European Union and Japan. Clin Cancer Res 2010;16:1737-44.
5. Newell DR, Silvester J, McDowell C, Burtles SS. The Cancer Research UK experience of pre-clinical toxicology studies to support early clinical trials with novel cancer therapies. Eur J Cancer 2004; 40:899-906.
6. Available from: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm078933.pdf.
7. Available from: http://www.ich.org/cache/html/4870-272-1.html.
8. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; 2009.
9. DeGeorge JJ, Ahn CH, Andrews PA, et al. Regulatory considerations for preclinical development of anticancer drugs. Cancer Chemother Pharmacol 1998;41:173-85.
10. Rock EP, Molloy VJ, Humphrey JS. Data quality for academic investigators. Clin Cancer Res 2010;16:1756-63.
11. Freireich EJ, Gehan EA, Rall DP, Schmidt LH, Skipper HE. Quantitative comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey and man. Cancer Chemother Rep 1966;50:219-44.
12. Clark DL, Andrews PA, Smith DD, DeGeorge JJ, Justice RL, Beitz JG. Predictive value of preclinical toxicology studies for platinum anticancer drugs. Clin Cancer Res 1999;5:1161-7.
13. Olson H, Betton G, Robinson D, et al. Concordance of the toxicity of pharmaceuticals in humans and in animals. Regul Toxicol Pharmacol 2000;32:56-67.
14. Sistare FD, DeGeorge JJ. Preclinical predictors of clinical safety: opportunities for improvement. Clin Pharmacol Ther 2007;82:210-4.
15. Fielden MR, Kolaja KL. The role of early in vivo toxicity testing in drug discovery toxicology. Expert Opin Drug Saf 2008;7:107-10.
16. Kramer JA, Sagartz JE, Morris DL. The application of discovery toxicology and pathology towards the design of safer pharmaceutical lead candidates. Nat Rev Drug Discov 2007;6:636-49.
17. Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004;3:711-5.
18. Double J, Barrass N, Barnard ND, Navaratnam V. Toxicity testing in the development of anticancer drugs. Lancet Oncol 2002;3:438-42.
19. Kerkela R, Grazette L, Yacobi R, et al. Cardiotoxicity of the cancer therapeutic agent imatinib mesylate. Nat Med 2006;12:908-16.
20. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Available from: http://www.ich.org/cache/compo/502-272-1.html#M3.
21. In: Williams G, Pazdur R, editors. Regulatory considerations in clinical trials of novel anticancer drugs. New York: Elsevier, Inc; 2006.
22. Food and Drug Administration (FDA). Available from: http://www.fda.gov/ OHRMS/DOCKETS/AC/06/briefing/2006-4203b1-02-FDA.Backgrounder.pdf.
23. Food and Drug Administration (FDA). Available from: http://www.fda.gov/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
24. Food and Drug Administration (FDA). Available from: http://ecfr. gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid= ee204a49f0c21ad50736fae72eff2173&rgn=div8&view=text&node=21:5.0.1.1. 3.2.1.4&idno=21.