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NCT05183126 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
A Phase 4 study of Breast Cancer and Esophageal Cancer, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05183126: Recruiting Phase 4 study of Breast Cancer and Esophageal Cancer, sponsored by University of Michigan Rogel Cancer Center.
NCT05183126 is a Phase 4 study of Breast Cancer and Esophageal Cancer that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 22 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05183126, a Phase 4 study of Breast Cancer and Esophageal Cancer, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low/sarcopenic SMA normalizes the levels to those of patients with normal SMA.
Primary Outcome
Compare Cmax in patients with lower SMA with an adjusted infusion duration (i.e., 2-hour or 3-hour) to that of patients with normal SMA receiving standard 1-hour infusion. Blood samples for pharmacokinetic analysis will be collected within 5 minutes prior to the end of SMA-based and standard paclitaxel infusions. Measurement of plasma paclitaxel concentration for Cmax will be conducted using a liquid chromatography/mass spectroscopy assay.
Conditions Studied
Interventions
- DRUG Paclitaxel
Study Locations (1)
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2026-06 |
| Phase | Phase 4 |
What NCT05183126 shows while recruiting
NCT05183126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Paclitaxel is the first listed.
NCT05183126 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05183126 about?
NCT05183126 is a clinical study titled "Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer". The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low/sarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour ...
What is the current status of trial NCT05183126?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2022-03-28. Estimated completion is 2026-06.
What conditions does trial NCT05183126 study?
This clinical trial studies the following conditions: Breast Cancer, Esophageal Cancer, Metastatic Gastric Cancer.
What interventions are being tested in trial NCT05183126?
The interventions under investigation include: Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT05183126?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05183126 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05183126's enrollment target sits among peer trials
22 1063rd of 1224 higher than 153 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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