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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary and study completion pushed from Jun 2026 to Nov 2026v11
  2. Primary and study completion dates: Dec 2025 to Jun 2026v10
  3. Primary and study completion dates: Mar 2025 to Dec 2025v9
  4. Eligibility criteria expanded, about 21 words
    • Study description expanded, about 25 words
    • Study title shortened, about 1 word
    v8
  5. Primary and study completion dates: Nov 2024 to Mar 2025v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary and study completion dates: May 2024 to Nov 2024v6
  2. Primary and study completion dates: Dec 2023 to May 2024v5
  3. Primary and study completion dates: Oct 2023 to Dec 2023v4
  4. Start date changed from estimate of Apr 2022 to Mar 28, 2022v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 2023 to Oct 2023
    • Start date: Jun 2022 to Apr 2022
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05183126
Lead Sponsor University of Michigan Rogel Cancer Center
Conditions
(from sponsor)		 Breast Cancer, Metastatic Gastric Cancer, Esophageal Cancer
Related terms Breast Neoplasms, Esophageal Neoplasms, Stomach Neoplasms
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov