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NCT05232409 · ClinicalTrials.gov registry record · Phase 1
Determine Safety & Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination w/Pembrolizumab in Patients With Metastatic Cancer
A Phase 1 study of Metastatic Solid Tumor and Cancer Metastatic, sponsored by Valley Health System.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT05232409: Recruiting Phase 1 study of Metastatic Solid Tumor and Cancer Metastatic, sponsored by Valley Health System.
NCT05232409 is a Phase 1 study of Metastatic Solid Tumor and Cancer Metastatic that is actively recruiting participants, run by Valley Health System. The registered enrollment target is 72 participants, below the 191-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05232409, a Phase 1 study of Metastatic Solid Tumor and Cancer Metastatic, is actively recruiting participants, sponsored by Valley Health System.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the research is to determine the highest dose of an oral compound called zeaxanthin that can be safely taken each day in patients with advanced cancer, the toxicity profile of zeaxanthin, and the dose of zeaxanthin to use in future cancer clinical trials.
Primary Outcome
Recommended maximum tolerated dose Highest dose of zeaxanthin that does not cause dose limiting toxicity in patients with unresectable advanced solid tumors treated with zeaxanthin
Conditions Studied
Interventions
- BIOLOGICAL Zeaxanthin
- COMBINATION_PRODUCT Zeaxanthin Plus Pembrolizumab
Study Locations (1)
New Jersey
- The Valley Hospital-Luckow Pavilion - Paramus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2022-04-17 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What NCT05232409 shows while recruiting
NCT05232409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 191-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (62% lower).
The record links to 2 conditions, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Zeaxanthin is the first listed.
NCT05232409 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT05232409 about?
NCT05232409 is a clinical study titled "Determine Safety & Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination w/Pembrolizumab in Patients With Metastatic Cancer". The purpose of the research is to determine the highest dose of an oral compound called zeaxanthin that can be safely taken each day in patients with advanced cancer, the toxicity profile of zeaxanthin, and the dose of zeaxanthin to use in future cancer clinical trials.
What is the current status of trial NCT05232409?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2022-04-17. Estimated completion is 2026-03.
What conditions does trial NCT05232409 study?
This clinical trial studies the following conditions: Metastatic Solid Tumor, Cancer Metastatic.
What interventions are being tested in trial NCT05232409?
The interventions under investigation include: Zeaxanthin (BIOLOGICAL), Zeaxanthin Plus Pembrolizumab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05232409?
This trial is sponsored by Valley Health System, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05232409 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05232409's enrollment target sits among peer trials
72 38th of 52 higher than 14 of 52 other Metastatic Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Solid Tumor 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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