RFA-CA-19-008: The Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratories (U24 Clinical Trial Not Allowed)
Internal Deadline: February 22, 2019, noon PT
LOI: 30 days prior to the application due date
External Deadline: May 22, 2019, by 5:00 PM local time of applicant organization..
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: 2
Anticipated Amount: NIH intends to commit $750,000 (total funds) in FY 2020 to fund up to 2 awards. Application budget requests are limited to $320,000 (direct costs) per year.
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- CV – (5 pages maximum)
Who May Serve as PI: Individual(s) designated as Program Director(s)/Principal Investigator(s) (PDs/PIs) are expected to be national and international leaders in cancer-related pharmacokinetic studies for early phase clinical trials of novel therapeutic agents and translational research.
Proposed investigators must be highly capable of inter- and trans-disciplinary team-based research with investigators involved in the design and conduct of clinical trials.
The purpose of this Funding Opportunity Announcement (FOA) issued by The National Cancer Institute (NCI) is to create Pharmacokinetics Resource Laboratories (PK Laboratories) that will support the Experimental Therapeutics Clinical Trials Network (ETCTN). The PK Laboratories will be expected to organize specimen collection and subsequent analysis 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. The ETCTN Pharmacokinetic Resource Laboratories will assure the availability of physicians, clinical pharmacologists, nurses and scientists who have the appropriate expertise in pharmacokinetic studies for early drug development and translational research. This FOA seeks U24 cooperative agreement applications from 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).
The research objective of the ETCTN is for the early-stage clinical development of novel cancer treatments that include NCI-IND agents based on sound preclinical findings, and that are consistent with national priorities for developmental therapeutics clinical cancer research. To meet this objective, all ETCTN awardees jointly will be expected to:
- Use a coordinated and collaborative integrated team science approach in the drug development process.
- Acquire high quality human specimens for ETCTN correlative laboratory studies.
- Integrate scientific rigor into biomarker development and clinical trials.
- Provide efficient and timely activation and conduct of clinical trials that meet regulatory requirements and Good Clinical Practice (GCP) standards and principles.
- Promote collaborations with cancer biology experts to investigate critical pathways and processes in the treatment of oncology patients with investigational drugs.
- Provide clinical study leadership opportunities for early career clinical investigators.
- Commit to enrollment of racial/ethnic and rural populations to decrease cancer disparities.
The ETCTN PK Laboratory awards will provide the major resource for rapid, efficient, systematic evaluation and determination of the ADME 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.
Visit our Institutionally Limited Submission webpage for updates and other announcements.