OncRef

Clinical Trial: NCT05183126

Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer

Status:

RECRUITING

Phase:

Phase 4

Lead Sponsor:University of Michigan Rogel Cancer Center
Information Provided By:University of Michigan Rogel Cancer Center
Last Update Posted:2026-07-02

Study Overview

Brief 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.

Official Title

Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer

Conditions

Breast Cancer, Metastatic Gastric Cancer, Esophageal Cancer

Intervention / Treatment

  • Drug: Paclitaxel
  • Drug: Paclitaxel

Other Study ID Numbers

  • UMCC 2021.109
  • HUM00207945

Start Date (Actual)

2022-03-28

Primary Completion Date (Estimated)

2026-11

Study Completion Date (Estimated)

2026-11

Enrollment (Estimated)

22

Study Type

Interventional

Phase

Phase 4