During FY08, the Clinical Pharmacology Program (CPP) provided support to over 40 clinical trials. This support ranged from sample pickup and processing, to full analytical method development and validation, pharmacokinetic and pharmacogenetic analysis and assistance with trial design. In FY09, the CPP received over 11,000 biological samples including blood, urine and bone marrow aspirate. Upon arrival, all samples are processed, barcoded and frozen for future use. The first priority in characterizing the pharmacokinetics of an anticancer agent is to develop a reliable and reproducible analytical method for quantitating agents in biological fluids and tissues. The CPP utilizes high performance liquid chromatograpy (HPLC) coupled with state-of-the-art detection instruments including mass spectrometers, tandem mass spectrometers (MS/MS) and diode array detectors (for UV absorption) to measure drug concentrations. Following method development, assays are validated according to the FDA Guidelines for Bioanalytical Method Development. The CPP is currently focused on the method development, validation and subsequent human sample analysis for sorafenib, finasteride, docetaxel, nelfinavir, and clopidogrel. The group has recently validated and published an assay for 17-DMAG, and sample analysis is ongoing in support of a Phase I clinical trial being conducted within the CCR. The CPP has previously developed analytical methods for a wide range of other therapeutics, including depsipeptide, TNP-470, phenylacetate, phenylbutyrate, tamoxifen, UCN-01, CAI, thalidomide, COL-3, suramin, melphalan, erlotinib, perifosine, SU5416, 2ME, MS-275, ketoconazole, and CC5013.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Scientific Cores Intramural Research (ZIC)
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National Cancer Institute Division of Clinical Sciences
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Jackson, Sadhana; Weingart, Jon; Nduom, Edjah K et al. (2018) The effect of an adenosine A2A agonist on intra-tumoral concentrations of temozolomide in patients with recurrent glioblastoma. Fluids Barriers CNS 15:2
Lee, Jung-Min; Peer, Cody J; Yu, Minshu et al. (2017) Sequence-Specific Pharmacokinetic and Pharmacodynamic Phase I/Ib Study of Olaparib Tablets and Carboplatin in Women's Cancer. Clin Cancer Res 23:1397-1406
Lee, Jung-Min; Hays, John L; Chiou, Victoria L et al. (2017) Phase I/Ib study of olaparib and carboplatin in women with triple negative breast cancer. Oncotarget 8:79175-79187
Dao, Kim; Chtioui, Haithem; Lu, Yimin et al. (2017) Pharmacokinetics of Pomalidomide in a Patient Receiving Hemodialysis Using a High-Cutoff Filter. Am J Kidney Dis 69:553-554
Dao, Kim; Lu, Yimin; Peer, Cody J et al. (2017) Pharmacokinetics of lenalidomide during high cut-off dialysis in a patient with multiple myeloma and renal failure. Cancer Chemother Pharmacol 79:215-218
Manasanch, Elisabet E; de Larrea, Carlos Fernández; Zingone, Adriana et al. (2017) Enzymatic activities of circulating plasma proteasomes in newly diagnosed multiple myeloma patients treated with carfilzomib, lenalidomide and dexamethasone. Leuk Lymphoma 58:639-645
Ferraz Nogueira Filho, Marco A; Peer, Cody J; Nguyen, Jeffers et al. (2017) A simple and rapid UHPLC-MS/MS method for the quantitation of the dual aurora kinase A/B inhibitor SCH-1473759 in murine plasma. J Pharm Biomed Anal 132:223-226
Lee, Jung-Min; Cimino-Mathews, Ashley; Peer, Cody J et al. (2017) Safety and Clinical Activity of the Programmed Death-Ligand 1 Inhibitor Durvalumab in Combination With Poly (ADP-Ribose) Polymerase Inhibitor Olaparib or Vascular Endothelial Growth Factor Receptor 1-3 Inhibitor Cediranib in Women's Cancers: A Dose-Escala J Clin Oncol 35:2193-2202
Uldrick, Thomas S; Gonçalves, Priscila H; Wyvill, Kathleen M et al. (2017) A Phase Ib Study of Sorafenib (BAY 43-9006) in Patients with Kaposi Sarcoma. Oncologist 22:505-e49
Goey, Andrew K L; Sissung, Tristan M; Peer, Cody J et al. (2016) Effects of UGT1A1 genotype on the pharmacokinetics, pharmacodynamics, and toxicities of belinostat administered by 48-hour continuous infusion in patients with cancer. J Clin Pharmacol 56:461-73

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