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

NCT05183126 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-03-06

No results posted yet for this 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.

Conditions

Interventions

DRUG

Paclitaxel

Weekly intravenous (IV) infusion of a standard dose of paclitaxel 80 mg/m\^2. Dose 1 is a 90-minute infusion. All other doses administered as a 1-hour infusion for a total of 12 weekly doses.

DRUG

Paclitaxel

Weekly intravenous (IV) infusion of a standard dose of paclitaxel 80 mg/m\^2. Dose 1 is a 90-minute infusion. During doses 2-12, patients with low SMA will receive one 2-hour infusion and patients with sarcopenic SMA will receive one 3-hour infusion. All other doses during weeks 2-12 are standard infusion time.

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Daniel L Hertz, PharmD, PhD · University of Michigan Rogel Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05183126 on ClinicalTrials.gov