VUMC Limited Submission Opportunity: NCI Experimental Therapeutics Clinical Trials Network Pharmacokinetic Resource Laboratories
These instructions are for VUMC investigators. VU investigators should apply through InfoReady and address any questions to VU-LSO@vanderbilt.edu.
Overview:
VUMC may submit one application to the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratories (U24 Clinical Trial Not Allowed).
This FOA will establish two Pharmacokinetics Resource Laboratories (PK Laboratories) as an infrastructure to support the ETCTN Clinical Sites. PK Laboratories will be responsible for the organization of specimen collection and subsequent analyses of pharmacokinetic endpoints, drug-drug interactions, cytochromes P450 (CYP) interactions, and food effects in ETCTN studies of NCI Investigational New Drug (IND) agents. The overarching goal of the ETCTN PK Laboratories is to advance the clinical development of NCI-IND agents through achieving comprehensive understanding of pharmacokinetic behavior of these agents studied in ETCTN protocols. PK laboratories should be multidisciplinary groups that will conduct all pharmacokinetic studies for ETCTN early phase clinical trials filed to the IND applications in NCI’s Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP).
Research Objectives and Main Requirements
The ETCTN PK Laboratory awards will provide the major resource for rapid, efficient, systematic evaluation and determination of the ADME (absorption, distribution, metabolism, and excretion) profiles in patients participating in early phase clinical trials. The ETCTN PK Laboratories will be responsible for establishing pharmacokinetic profiles of NCI-IND anticancer agents and their metabolites in blood. Specific agents (alone and in combinations) will be analyzed for their half-lives and rates of elimination for these investigational agents to ensure the safe and effective therapeutic management of drugs in an individual patient. The ETCTN PK Laboratories will provide:
- Technical and clinical evaluation of assays for study drug(s) PK that are quality assured/quality controlled and standardized for use in plasma and/or tumor tissue;
- Evaluation of drug-drug interaction risk for each drug and its active metabolites in relationship to other therapeutics and concomitant medications;
- Definition of PK sampling strategies, limited sampling strategies and population PK;
- Evaluation of PK in plasma and tissue; and
- Timely reporting and analysis to the study team and to NCI of the results of PK analyses.
See the solicitation for a full list of Specific Research Capabilities and Requirements.
Internal Application Process:
Anyone interested in being considered as VUMC’s nominee must submit the following to LSO@vanderbilt.edu by 5 p.m. on Feb. 22. Please combine your materials into a single PDF and reference the program name in the subject line of the email.
- Brief research plan including summary budget (2 page max including budget);
- Statement of support from department chair/center director;
- NIH Biosketch for PI