NCI Experimental Therapeutics Clinical Trials Network (ETCTN)

• Overview/Objectives
• Participating Clinical Sites
• Infrastructure
• ETCTN Trials
• ETCTN Publication Policy
• ETCTN Monitoring Guidelines
• Interventional Radiology SOP
• EDDOP-ETCTN Leadership Program Supplement
• Institutional Certification for ETCTN Trials

2019 FOAs for the ETCTN and PK Resource Laboratories

• Q&A (Questions & Answers) regarding the FOAs
• ETCTN FOA
• PK Resource Laboratories FOA
• Correction Notice for the PK Resource Laboratories FOA

Pre-application Webinar on Feb. 6, 2019, for ETCTN and PK Resources Laboratories

• Slides from ETCTN FOA Webinar
• Webinar Notice
• Pre-application Webinar for the ETCTN and the ETCTN Pharmacokinetic Resource Laboratories (2 hr 6 min)

Overview/Objectives

The National Cancer Institute (NCI) has formed partnerships in the pharmaceutical industry, academic institutions, and individual investigators for the early clinical evaluation of innovative cancer therapies. The Experimental Therapeutics Clinical Trials Network (ETCTN) was created to evaluate these therapies using a coordinated, collaborative, and inclusive team-based approach to early phase experimental therapeutic clinical trials.

The objectives of the ETCTN are to:

• Conduct early clinical trials of NCI-IND agents in high priority areas of unmet medical needs
• Ensure efficient and timely activation and conduct of these clinical trials
• Integrate preclinical findings using clinical samples for biomarker analysis
• Promote collaboration among institutions and investigators
• Integrate molecular characterization, pharmacology, cancer biology, and imaging into clinical trials

See the links in the sidebar for more information about the ETCTN.

ETCTN Participating Sites

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ETCTN Phase 1 and Phase 2 Program Sites

ETCTN clinical sites (see map above) participate in a Phase 1 Program supported by UM1 grants, integrated with a Phase 2 Program supported by cooperative agreements as supplements to the existing phase 1 UM1 grant. By integrating Phase 1 and Phase 2 Program activities and administrative operations under the UM1 structure, ETCTN awardees will have the flexibility to expand phase 1 studies quickly upon detecting early activity signals.

*LAO = Lead Academic Organization

NCI Early Drug Development Opportunity Program (EDDOP)

Beginning in 2016, investigators from certain NCI-designated Cancer Centers not affiliated with the ETCTN may submit a Letter of Intent (LOI) and, if approved, receive full ETCTN support for the clinical trial. Non-ETCTN NCI Cancer Centers will also be able to compete for administrative supplements to enroll patients on select ETCTN phase 2 trials. Click here for more information about the EDDOP.

NCI-sponsored Infrastructure for ETCTN Trials

ETCTN trials are supported by integrated centralized clinical and administrative services sponsored by NCI. More details, and links to each service, may be found here.