The Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratory (U24 Clinical Trial Not Allowed)

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications from institutions/organizations that propose to maintain or establish a Pharmacokinetics Resource Laboratory (PK Laboratory) to support the Experimental Therapeutics Clinical Trials Network (ETCTN). The PK Laboratory will organize biospecimen collections and provide subsequent analyses of pharmacokinetic endpoints, drug-drug interactions, cytochrome P450 (CYP) interactions, pharmacodynamics, and food effects in ETCTN studies of NCI Investigational New Drug (IND) agents. The overarching goal of the ETCTN PK Laboratory is to advance the clinical development of NCI IND agents by providing a comprehensive understanding of pharmacokinetic behavior of these agents under study in ETCTN trials. The ETCTN PK Laboratory will engage physicians, clinical pharmacologists, nurses, and scientists who have appropriate expertise in pharmacokinetic studies for early drug development and translational research. This NOFO seeks U24 applications from multidisciplinary institutions/organizations to conduct all pharmacokinetic studies for ETCTN early phase clinical trials filed to IND applications in the NCI Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP).

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications from institutions/organizations that propose to maintain or establish a Pharmacokinetics Resource Laboratory (PK Laboratory) to support the Experimental Therapeutics Clinical Trials Network (ETCTN). The PK Laboratory will organize biospecimen collections and provide subsequent analyses of pharmacokinetic endpoints, drug-drug interactions, cytochrome P450 (CYP) interactions, pharmacodynamics, and food effects in ETCTN studies of NCI Investigational New Drug (IND) agents. The overarching goal of the ETCTN PK Laboratory is to advance the clinical development of NCI IND agents by providing a comprehensive understanding of pharmacokinetic behavior of these agents under study in ETCTN trials. The ETCTN PK Laboratory will engage physicians, clinical pharmacologists, nurses, and scientists who have appropriate expertise in pharmacokinetic studies for early drug development and translational research. This NOFO seeks U24 applications from multidisciplinary institutions/organizations to conduct all pharmacokinetic studies for ETCTN early phase clinical trials filed to IND applications in the NCI Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP).

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/Foreign Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.