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NCT04086485 · ClinicalTrials.gov registry record · Phase 1
Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)
A Phase 1 study of Neuroendocrine Tumors and Neuroendocrine Neoplasms, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT04086485: Recruiting Phase 1 study of Neuroendocrine Tumors and Neuroendocrine Neoplasms, sponsored by National Cancer Institute (NCI).
NCT04086485 is a Phase 1 study of Neuroendocrine Tumors and Neuroendocrine Neoplasms that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 56 participants, below the 179-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04086485, a Phase 1 study of Neuroendocrine Tumors and Neuroendocrine Neoplasms, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: A neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors. Objective: To learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lutathera and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink. Eligibility: Adults 18 and older who have a neuroendocrine tumor in the pancreas or intestine that cannot be cured by surgery and has somatostatin receptors on the cells. Design: Eligible participants will get Lutathera through an intravenous (IV) infusion every 8 weeks for 4 cycles. One cycle is 8 weeks. Each cycle includes a follow-up visit at week 4. For the IV, a small plastic tube is put into an arm vein. Participants will also take Olaparib by mouth twice a day for 4 weeks of each cycle. They will use a medicine diary to track the doses. During the study, participants will have physical exams. They will have blood and urine tests. They will fill out questionnaires about their general well-being and function. Their heart function will be tested. They will have scans of their chest, abdomen, and pelvis. One type of scan will use an IV infusion of a radioactive tracer. Participants will have a follow-up visit about 4 weeks after treatment ends. Then they will have follow-up visits every 12 weeks for 3 years. Then they will have yearly phone calls.
Primary Outcome
Depending on what the speed of dose escalation and the final MTD dose, it is estimated that for 4 dose levels with up to 6 patients at each level, approximately 12 to 24 patients will be required for the phase I portion of the study. Standard 3+3 design will be used.
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG Lu-177-DOTATATE
- DIAGNOSTIC_TEST Ga dotatate scanning
- DIAGNOSTIC_TEST FDG-PET scanning
- DRUG Amino Acid infusion
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 1 |
What NCT04086485 shows while recruiting
NCT04086485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 179-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (69% lower).
The record links to 3 conditions, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 5 interventions - of which Olaparib is the first listed.
NCT04086485 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04086485 about?
NCT04086485 is a clinical study titled "Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)". Background: A neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors. Objective: To learn if peop...
What is the current status of trial NCT04086485?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2022-10-03. Estimated completion is 2028-01-01.
What conditions does trial NCT04086485 study?
This clinical trial studies the following conditions: Neuroendocrine Tumors, Neuroendocrine Neoplasms, Gastroenteropancreatico Tumors.
What interventions are being tested in trial NCT04086485?
The interventions under investigation include: Olaparib (DRUG), Lu-177-DOTATATE (DRUG), Ga dotatate scanning (DIAGNOSTIC_TEST), FDG-PET scanning (DIAGNOSTIC_TEST), Amino Acid infusion (DRUG).
Who is sponsoring clinical trial NCT04086485?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04086485 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04086485's enrollment target sits among peer trials
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Each bar is a band; taller bars hold more other Neuroendocrine Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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