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NCT04234568 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors
A Phase 1 study of Metastatic Digestive System Neuroendocrine Neoplasm and Metastatic Neuroendocrine Tumor, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 11
- Study locations
NCT04234568: Active Phase 1 study of Metastatic Digestive System Neuroendocrine Neoplasm and Metastatic Neuroendocrine Tumor, sponsored by National Cancer Institute (NCI).
NCT04234568 is a Phase 1 study of Metastatic Digestive System Neuroendocrine Neoplasm and Metastatic Neuroendocrine Tumor that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04234568, a Phase 1 study of Metastatic Digestive System Neuroendocrine Neoplasm and Metastatic Neuroendocrine Tumor, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
The MTD and RP2D will be estimated using isotonic regression based on observed dose limiting toxicity from all patients enrolled in the phase 1 portion and expansion cohort. All patients who received study drugs will be included in the safety analysis.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Lutetium Lu 177 Dotatate
- DRUG Triapine
Study Locations (11)
Florida
- Mayo Clinic in Florida - Jacksonville
- Moffitt Cancer Center - Tampa
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
California
- City of Hope Comprehensive Cancer Center - Duarte
Illinois
- Northwestern University - Chicago
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Massachusetts
- Dana-Farber Cancer Institute - Boston
Minnesota
- Mayo Clinic in Rochester - Rochester
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-07-20 |
| Est. Completion | 2026-03-14 |
| Phase | Phase 1 |
What the registry record for NCT04234568 still lists
NCT04234568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Metastatic Digestive System Neuroendocrine Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04234568 lists 11 locations in 10 states (Florida, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT04234568 about?
NCT04234568 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors". 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 lute...
What is the current status of trial NCT04234568?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2020-07-20. Estimated completion is 2026-03-14.
What conditions does trial NCT04234568 study?
This clinical trial studies the following conditions: Metastatic Digestive System Neuroendocrine Neoplasm, Metastatic Neuroendocrine Tumor.
What interventions are being tested in trial NCT04234568?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Lutetium Lu 177 Dotatate (DRUG), Triapine (DRUG).
Who is sponsoring clinical trial NCT04234568?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04234568 being conducted?
This trial has 11 study locations across Arizona, California, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04234568's enrollment target sits among peer trials
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