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Phase 0 clinical trials in cancer drug development: from FDA guidance to clinical practice.
Kinders R, Parchment RE, Ji J, Kummar S, Murgo AJ, Gutierrez M, Collins J, Rubinstein L, Pickeral O, Steinberg SM, Yang S, Hollingshead M, Chen A, Helman L, Wiltrout R, Simpson M, Tomaszewski JE, Doroshow JH. Kinders R, et al. Among authors: parchment re. Mol Interv. 2007 Dec;7(6):325-34. doi: 10.1124/mi.7.6.9. Mol Interv. 2007. PMID: 18199854 Review.
Compressing drug development timelines in oncology using phase '0' trials.
Kummar S, Kinders R, Rubinstein L, Parchment RE, Murgo AJ, Collins J, Pickeral O, Low J, Steinberg SM, Gutierrez M, Yang S, Helman L, Wiltrout R, Tomaszewski JE, Doroshow JH. Kummar S, et al. Among authors: parchment re. Nat Rev Cancer. 2007 Feb;7(2):131-9. doi: 10.1038/nrc2066. Nat Rev Cancer. 2007. PMID: 17251919 Review.
Phase 0 clinical trials: conceptions and misconceptions.
Kummar S, Rubinstein L, Kinders R, Parchment RE, Gutierrez ME, Murgo AJ, Ji J, Mroczkowski B, Pickeral OK, Simpson M, Hollingshead M, Yang SX, Helman L, Wiltrout R, Collins J, Tomaszewski JE, Doroshow JH. Kummar S, et al. Among authors: parchment re. Cancer J. 2008 May-Jun;14(3):133-7. doi: 10.1097/PPO.0b013e318172d6f3. Cancer J. 2008. PMID: 18536551 Free PMC article. Review.
Designing phase 0 cancer clinical trials.
Murgo AJ, Kummar S, Rubinstein L, Gutierrez M, Collins J, Kinders R, Parchment RE, Ji J, Steinberg SM, Yang SX, Hollingshead M, Chen A, Helman L, Wiltrout R, Tomaszewski JE, Doroshow JH. Murgo AJ, et al. Among authors: parchment re. Clin Cancer Res. 2008 Jun 15;14(12):3675-82. doi: 10.1158/1078-0432.CCR-07-4560. Clin Cancer Res. 2008. PMID: 18559582 Free PMC article.
Preclinical modeling of a phase 0 clinical trial: qualification of a pharmacodynamic assay of poly (ADP-ribose) polymerase in tumor biopsies of mouse xenografts.
Kinders RJ, Hollingshead M, Khin S, Rubinstein L, Tomaszewski JE, Doroshow JH, Parchment RE; National Cancer Institute Phase 0 Clinical Trials Team. Kinders RJ, et al. Among authors: parchment re. Clin Cancer Res. 2008 Nov 1;14(21):6877-85. doi: 10.1158/1078-0432.CCR-08-0214. Clin Cancer Res. 2008. PMID: 18980982 Free PMC article.
The statistics of phase 0 trials.
Rubinstein LV, Steinberg SM, Kummar S, Kinders R, Parchment RE, Murgo AJ, Tomaszewski JE, Doroshow JH. Rubinstein LV, et al. Among authors: parchment re. Stat Med. 2010 May 10;29(10):1072-6. doi: 10.1002/sim.3840. Stat Med. 2010. PMID: 20419759 Free PMC article.
Pharmacodynamic Response of the MET/HGF Receptor to Small-Molecule Tyrosine Kinase Inhibitors Examined with Validated, Fit-for-Clinic Immunoassays.
Srivastava AK, Hollingshead MG, Weiner J, Navas T, Evrard YA, Khin SA, Ji JJ, Zhang Y, Borgel S, Pfister TD, Kinders RJ, Bottaro DP, Linehan WM, Tomaszewski JE, Doroshow JH, Parchment RE. Srivastava AK, et al. Among authors: parchment re. Clin Cancer Res. 2016 Jul 15;22(14):3683-94. doi: 10.1158/1078-0432.CCR-15-2323. Epub 2016 Mar 21. Clin Cancer Res. 2016. PMID: 27001313 Free PMC article.
119 results