The National Cancer Institute (NCI) offers this grant to enhance its program for conducting early phase clinical trials in children with cancer. This initiative aims to facilitate the timely introduction of high-priority novel agents into pediatric oncology. The Pediatric Early Phase Clinical Trials Network (PEP-CTN) grant is primarily for designing and conducting pediatric phase 1 trials, often incorporating phase 2 expansion cohorts. This efficient approach allows intensive monitoring for agent toxicity during their initial evaluation in children. The grant also supports phase 2 studies once phase 1 testing results are available, and pilot studies of novel regimens to determine tolerability, paving the way for definitive testing in phase 3 clinical trials.
Opportunity ID: 349999
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-CA-24-007 |
| Funding Opportunity Title: | Single Source: Pediatric Early Phase Clinical Trials Network (PEP-CTN; UM1 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.395 — Cancer Treatment Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Aug 25, 2023 |
| Last Updated Date: | Aug 25, 2023 |
| Original Closing Date for Applications: | Nov 15, 2023 |
| Current Closing Date for Applications: | Nov 15, 2023 |
| Archive Date: | Dec 21, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to enhance NCIs program for conducting early phase clinical trials in children with cancer, thereby facilitating the introduction of high priority novel agents into the pediatric oncology setting in a timely manner. This ability to quickly conduct first in children studies is critical to NCIs overall clinical research program for children with cancer. The primary scope of the Pediatric Early Phase Clinical Trials Network (PEP-CTN) is to design and conduct pediatric phase 1 trials that will often include phase 2 expansion cohorts. Conduct of the phase 2 study components within the PEP-CTN is efficient and allows intensive study monitoring for toxicity for these agents undergoing their initial evaluation in children. When phase 1 testing results for an agent are available, phase 2 studies will also be within the remit of the PEP-CTN. As well, the PEP-CTN will conduct pilot studies of novel regimens to determine their tolerability so that they can proceed to definitive testing in phase 3 clinical trials. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-24-007.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 349999 Full Announcement-RFA-CA-24-007 -> RFA-CA-24-007-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00282983 | Oct 15, 2023 | Nov 15, 2023 | View |
Package 1
Mandatory forms
349999 RR_SF424_5_0-5.0.pdf
349999 PHS398_CoverPageSupplement_5_0-5.0.pdf
349999 RR_OtherProjectInfo_1_4-1.4.pdf
349999 PerformanceSite_4_0-4.0.pdf
349999 RR_KeyPersonExpanded_4_0-4.0.pdf
349999 RR_Budget_3_0-3.0.pdf
349999 PHS398_ResearchPlan_5_0-5.0.pdf
349999 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
349999 RR_SubawardBudget30_3_0-3.0.pdf
349999 PHS_AssignmentRequestForm_3_0-3.0.pdf
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