The CPP provides a range of services to support the conduct of clinical trials, and serves as a resource for clinicians seeking advice on study design. Visit each of our four sections, below, to view and access available services.
Clinical Pharmacology Program
Clinical Pharmacology Program
About
The mission of the Clinical Pharmacology Program (CPP) is to fully characterize the clinical pharmacology of new anticancer agents entering CCR clinics. Based within the Office of the Clinical Director, the CPP provides services and expertise to all CCR investigators and is the only group available to CCR investigators for clinical pharmacology collaboration.
Dr. William Figg has directed the CPP since its inception in 1992. Dr. Figg is a Senior Investigator and Acting Chief of the Genitourinary Malignancies Branch (GMB) and heads the Molecular Pharmacology Section. Dr. Figg also co-chairs (with Dr. Pat Steeg) the Office of Translational Resources.
Dr. Tristan Sissung serves as Deputy Director.
Leadership
Phone
Have questions or need additional information?
You can contact Dr. Keith Schmidt via phone or email.
240-858-3208 or keith.schmidt@nih.gov
Team
BPC
Paula Carter, BS, MHA
Trung Pham, MS
Diane Roame
Veronica Krevinko, MS
Sheryl Gere Ehrlich, MA
Hannah Mendiola, BS
Turina Lewis, BS
Paul Nolen
Emily McIntyre, BS
PPS
Vijaya Karra, PhD
Tobi Arisa, DPhil
Will Richardson, BS
Natalia Corvalan, BS
Rachel Ashe, BS
Pharmacogenetics
Tristan Sissung, MS, PhD
Clinical Section
Keith Schmidt, PharmD, PhD
Crystal Vasquez, PharmD
Lisa Cordes, PharmD
PreClinical PK
Tryston Metz, PhD
Roger Depaz
Publications
Pharmacokinetic and Pharmacometrics Section (PPS)
1. A Pharmacokinetic Simulation Analysis of Less Frequent Nivolumab and Pembrolizumab Dosing: Pharmacoeconomic Rationale for Dose De-Escalation. Peer CJ, Heiss BL, Goldstein DA, Goodell JC, Figg WD, Ratain MJ. J Clin Pharmacol. 2021 Oct 14. doi: 10.1002/jcph.1984. Online ahead of print. PMID: 34648187
2. Phase I Study of Zotiraciclib in Combination with Temozolomide for Patients with Recurrent High-grade Astrocytomas. Wu J, Yuan Y, Long Priel DA, Fink D, Peer CJ, Sissung TM, Su YT, Pang Y, Yu G, Butler MK, Mendoza TR, Vera E, Ahmad S, Bryla C, Lindsley M, Grajkowska E, Mentges K, Boris L, Antony R, Garren N, Siegel C, Lollo N, Cordova C, Aboud O, Theeler BJ, Burton EM, Penas-Prado M, Leeper H, Gonzales J, Armstrong TS, Calvo KR, Figg WD, Kuhns DB, Gallin JI, Gilbert MR. Clin Cancer Res. 2021 Jun 15;27(12):3298-3306. PMID: 33785481
3. Development and validation of a simple, selective, and sensitive LC-MS/MS assay for the quantification of remdesivir in human plasma. Nguyen R, Goodell JC, Shankarappa PS, Zimmerman S, Yin T, Peer CJ, Figg WD. J Chromatogr B Analyt Technol Biomed Life Sci. 2021 May 1;1171:122641. doi: 10.1016/j.jchromb.2021.122641. Epub 2021 Mar 10.
4. Population pharmacokinetic analysis of nanoparticle-bound and free camptothecin after administration of NLG207 in adults with advanced solid tumors. Schmidt KT, Huitema ADR, Dorlo TPC, Peer CJ, Cordes LM, Sciuto L, Wroblewski S, Pommier Y, Madan RA, Thomas A, Figg WD. Cancer Chemother Pharmacol. 2020 Oct; 86(4):475-486. PMID: 32897402
5. Selumetinib in Children with Inoperable Plexiform Neurofibromas.Gross AM, Wolters PL, Dombi E, Baldwin A, Whitcomb P, Fisher MJ, Weiss B, Kim A, Bornhorst M, Shah AC, Martin S, Roderick MC, Pichard DC, Carbonell A, Paul SM, Therrien J, Kapustina O, Heisey K, Clapp DW, Zhang C, Peer CJ, Figg WD, Smith M, Glod J, Blakeley JO, Steinberg SM, Venzon DJ, Doyle LA, Widemann BC. N Engl J Med. 2020 Apr 9; 382(15):1430-1442. PMID: 32187457
6. Measurement of NLG207 (formerly CRLX101) nanoparticle-bound and released camptothecin in human plasma. Schmidt KT, Peer CJ, Huitema ADR, Williams MD, Wroblewski S, Schellens JHM, Madan RA, Figg WD. J Pharm Biomed Anal. 2020 Mar 20;181:113073. PMID: 31927166.
7. A population pharmacokinetic/toxicity model for the reduction of platelets during a 48-h continuous intravenous infusion of the histone deacetylase inhibitor belinostat. Peer CJ, Hall OM, Sissung TM, Piekarz R, Balasubramaniam S, Bates SE, Figg WD. Cancer Chemother Pharmacol. 2018 Sep; 82(3):565-570. PMID: 29951694
8. A sensitive and rapid ultra high-performance liquid chromatography with tandem mass spectrometric assay for the simultaneous quantitation of cyclophosphamide and the 4-hydroxycyclophosphamide metabolite in human plasma. Hall OM, Peer CJ, Fitzhugh CD, Figg WD. J Chromatogr B Analyt Technol Biomed Life Sci. 2018 Jun 1;1086:56-62. PMID: 29656084
9. Quantitative determination of mithramycin in human plasma by a novel, sensitive ultra-HPLC-MS/MS method for clinical pharmacokinetic application. Roth J, Peer CJ, Widemann B, Cole DE, Ershler R, Helman L, Schrump D, Figg WD. J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Nov 1;970:95-101. PMID: 25247492
10. Quantification of irinotecan, SN38, and SN38G in human and porcine plasma by ultra high-performance liquid chromatography-tandem mass spectrometry and its application to hepatic chemoembolization. Chen X, Peer CJ, Alfaro R, Tian T, Spencer SD, Figg WD. J Pharm Biomed Anal. 2012 Mar 25;62:140-8. PMID: 22305081
Pharmacogenetics Section (PG)
1. Phase 1 study of sorafenib and irinotecan in pediatric patients with relapsed or refractory solid tumors. Meany HJ, Widemann BC, Hinds PS, Bagatell R, Shusterman S, Stern E, Jayaprakash N, Peer CJ, Figg WD, Hall OM, Sissung TM, Kim A, Fox E, London WB, Rodriguez-Galindo C, Minturn JE, Dome JS. Pediatr Blood Cancer. 2021 Aug 12:e29282. doi: 10.1002/pbc.29282. Online ahead of print. PMID: 34383370
2. Case report: severe toxicity in an African-American patient receiving FOLFOX carrying uncommon allelic variants in DPYD. Sissung TM, Cordes L, Peer CJ, Gandhy S, Redman J, Strauss J, Figg WD. Pharmacogenomics. 2021 Jan;22(2):81-85.PMID: 33305610
3. Severe Hepatotoxicity of Mithramycin Therapy Caused by Altered Expression of Hepatocellular Bile Transporters. Sissung TM, Huang PA, Hauke RJ, McCrea EM, Peer CJ, Barbier RH, Strope JD, Ley AM, Zhang M, Hong JA, Venzon D, Jackson JP, Brouwer KR, Grohar P, Glod J, Widemann BC, Heller T, Schrump DS, Figg WD. Mol Pharmacol. 2019 Aug;96(2):158-167. PMID: 31175181
4. Carfilzomib and lenalidomide response related to VEGF and VEGFR2 germline polymorphisms. Sissung TM, Peer CJ, Korde N, Mailankody S, Kazandjian D, Venzon DJ, Landgren O, Figg WD. Cancer Chemother Pharmacol. 2017 Jul;80(1):217-221. PMID: 28488026
5. Effects of UGT1A1 genotype on the pharmacokinetics, pharmacodynamics, and toxicities of belinostat administered by 48-hour continuous infusion in patients with cancer. Goey AK, Sissung TM, Peer CJ, Trepel JB, Lee MJ, Tomita Y, Ehrlich S, Bryla C, Balasubramaniam S, Piekarz R, Steinberg SM, Bates SE, Figg WD. J Clin Pharmacol. 2016 Apr;56(4):461-73. PMID: 26313268