CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 31 enrolled / 31 target
Drug / intervention
Lutetium Lu 177 Dotatate +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04234568
NCT04234568Phase 1ActiveUpdate Overdue (0.4/mo)Completion was 21mo ago

A Phase I Trial of Triapine and Lutetium Lu 177 Dotatate in Combination for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

National Cancer Institute (NCI)·interventional·Posted Jan 21, 2020·Updated Jun 1, 2026

In Brief

A Phase 1 clinical trial evaluating Biospecimen Collection, Computed Tomography, and 3 other interventions for Metastatic Digestive System Neuroendocrine Neoplasm and Metastatic Neuroendocrine Tumor. Active but no longer recruiting, targeting 31 participants across 11 sites.

Signals

Enrollment appears stalled

Detailed Summary

This phase I trial studies the side effects and best dose of triapine when given together with lutetium Lu 177 dotatate in treating patients with neuroendocrine tumors. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. Giving triapine and lutetium Lu 177 dotatate together may work better to treat patients with neuroendocrine tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1Active
20202021202220232024202520262027
First PostedJan 21, 2020
Enrollment StartJul 20, 2020
Primary CompletionSep 17, 2024
Study CompletionMar 13, 2027
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.4 years ago

Arms & Interventions

Treatment (lutetium Lu 177 dotatate, triapine)experimental

Patients receive lutetium Lu 177 dotatate IV for 30 to 40 minutes on day 1 of each cycle and triapine PO on days 1 throughout 14 of each cycle. Cycles repeat every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI scan throughout the trial. Patients undergo blood specimen collection on study.

Procedure: Biospecimen CollectionProcedure: Computed TomographyDrug: Lutetium Lu 177 DotatateProcedure: Magnetic Resonance ImagingDrug: Triapine

Interventions

Biospecimen Collectionprocedure

Correlative studies

Computed Tomographyprocedure

Undergo CT

Lutetium Lu 177 Dotatatedrug

Given IV

Magnetic Resonance Imagingprocedure

Undergo MRI

Triapinedrug

Given PO