Clinical Pharmacology

The Clinical Pharmacology Shared Resource (CPSR) provides critical scientific and technical support for the development and performance of clinical trials and dissemination of the trial results. This support is essential for early-phase clinical trials, including first-in-human studies, but also adds significant value to clinical trials focused on new applications and new combinations of current therapeutics. The guidance and support from the CPSR ensure clinical trials are comprehensive, driving the development and advancement of therapeutic and preventative approaches for cancer.

The CPSR has 5 aims:

1. Provide clinical pharmacology expertise to investigators and support them as they develop, seek funding and implement clinical trials.
2. Develop, codify and perform proper acquisition, processing and either short-term storage or shipping of clinical trial research samples (blood, urine, saliva, feces, cells, tissue).
3. Develop, validate and perform GLP (good laboratory practice)-compliant quantitative analysis of drugs and their metabolites and of endogenous small molecule biomarkers in clinical trial patient samples.
4. Perform pharmacokinetic calculations, analysis and interpretation, then present those findings for clinical trials.
5. Educate investigators and team members in the theory and application of clinical pharmacology to research in the identification, development and testing of new chemical entities, or for new applications of existing chemical entities, in clinical trials.

These services are provided to support cancer therapeutics trials, including studies of drug repurposing and novel drug combinations, and to the measurement of a full range of tobacco biomarkers for population studies of smoking cessation and of relative risks from various forms of tobacco and nicotine, including smoked and smokeless tobacco, nicotine replacement therapy and e-cigarettes.

All services of the CPSR are available to members of The University of Kansas Cancer Center at all campus locations, as well as Masonic Cancer Alliance and community sites. Bioanalytical and pharmacokinetics services are available to cancer center members as well as researchers from other institutions worldwide.

View Clinical Pharmacology brochure.

CPX-POM first in-human study

Ciclopirox Prodrug (CPX-POM), a prodrug for the active species CPX, was developed with support from the Lead Development and Optimization Shared Resource. CPX-POM selectively delivers the active drug to the urinary tract following systemic administration. A multicenter, Phase I dose-escalation study characterized the pharmacokinetics of CPX-POM, CPX and CPX-glucuronide in both plasma and urine, evaluated dose-limiting toxicities and determined the recommended Phase II dose for CPX-POM. All drug and metabolite concentrations for the study were determined in the CPSR. Learn more.

Low-dose daunorubicin

Preclinical studies conducted by National Cancer Institute consortium partner Stowers Institute for Medical Research were translated into a clinical trial of low-dose daunorubicin in patients with relapsed/refractory acute myelogenous leukemia. CPSR assisted in the design and development of protocols and performed the sample acquisition and processing for PK and biomarkers, analysis of daunorubicin in plasma samples, and PK calculations and modeling for the study. Learn more.

Cite the Cancer Center Support Grant

This resource is funded by The University of Kansas Cancer Center Support Grant (CCSG) awarded by the National Cancer Institute (P30 CA168524). Publications that have utilized facility resources, services or scientific data generated by the resource should acknowledge the resource and cite the NCI CCSG grant.