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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Scientific Cores Intramural Research (ZIC)
Project #
1ZICSC006536-16
Application #
7970164
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
16
Fiscal Year
2009
Total Cost
$446,039
Indirect Cost
Name
National Cancer Institute Division of Clinical Sciences
Department
Type
DUNS #
City
State
Country
Zip Code
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
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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
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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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