Shared Resources and Core Facilities
Clinical Pharmacology
The Clinical Pharmacology Shared Resource (CPSR) supports the clinical and translational research needs of The University of Kansas Cancer Center. It provides critical scientific and technical support for the development and performance of clinical trials and the dissemination of the trial results. This includes utilizing state-of-the-art commercial software programs for application in pharmacokinetic (PK) and pharmacodynamic (PD) modeling. This support is essential for early-phase clinical trials, including first-in-human studies. It also adds significant value to clinical trials focused on new applications and new indications for, or combinations of, FDA-approved 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:
- Provide clinical pharmacology expertise in the design of hypothesis-driven investigator-initiated trials (IITs).
- Provide logistic support for IIT-specific sample collection, processing, storage and transfer for biological samples collected for pharmacokinetic (PK) and pharmacodynamic (PD) analyses.
- Provide bioanalytical chemistry expertise for the quantification of both small and large molecule drugs and metabolites as well as biomarkers.
- Provide PK/PD expertise to analyze, interpret and report resultant plasma drug / metabolite and biomarker concentration-time data.
- Provide clinical pharmacology training and education to graduate students, postdoctoral fellows, hematology/oncology fellows and cancer center program members.
These services are provided to support cancer therapeutics trials, including studies of drug repurposing and novel drug combinations. Additionally, CPSR has the capabilities to quantify 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.
Their flexibility to add extra biomarkers to our analyses provided us with more detailed assessments of tobacco product and nicotine use, as well as some inherent health risks of that use. –Nikki Nollen, PhD
Co-leader, Cancer Prevention and Control research program
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 the University of Kansas Medical Center and other institutions worldwide.
[00:00:00] My name is Brent Sear and I'm the director of the Clinical Pharmacology shared resource.
“How does your shared resource support researchers?”
The CPSR is comprised of three different units, the Bioanalytical Lab - which takes care of sample analysis, so we quantify small molecule drugs, metabolites, biomarkers in the patient samples - the Correlative Lab - who are experts in sample acquisition, as well as processing and transfer of those samples - and then the Clinical Pharmacokinetics Unit, which will analyze and report all of the relevant PK or PD data from the trial.
“Can you give an example of when your shared resource contributed to a study with major scientific impact? How did you contribute?”
The Bioanalytical Lab served as the sole bioanalytical support group for a clinical trial on a drug called eflornithine, also known as DFMO, and it ended up being FDA approved for prevention of relapse in adult and pediatric neuroblastoma. [00:01:00]
“Why should researchers consider partnering with your shared resource on their next project?”
All three of our teams, the Bioanalytical Lab, the Correlative Lab, and the Clinical Pharmacokinetics Unit provide state-of-the-art care for your research at a very reasonable cost. We do have internal prices for all of our work. So while we are not as expensive as partnering with a CRO, we are able to get you the best bang for the buck for your research.
“How can researchers connect with you to initiate a project?”
Contacting us is pretty simple. You can email us, my email address is bsear@kc.edu. You can also just go to the CPSR'S website, where our various team members all have their email addresses linked there.
CPSR’s support included acquisition and processing of patient samples, application of validated analytical methods for measuring drug metabolite concentrations and interpretation of pharmacokinetic calculations. –Joaquina Baranda, MD
Medical Director, KU Cancer Center Early Phase Program
Services and Equipment
Contact us
Request our services.
Engage the Clinical Pharmacology Shared Resource on your project. Email your service request.
Research highlights
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.
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.Learn more
Interested in becoming a cancer center member?
To apply, click here. Applications are accepted throughout the year. Contact Lisa Harlan-Williams at lharlan-williams@kumc.edu for more information regarding membership.