NCT05183126 Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
| NCT ID | NCT05183126 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Michigan Rogel Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2022-03-28 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 22 participants in total. It began in 2022-03-28 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Planned paclitaxel 80 mg/m\^2, 1-hour infusion * Evaluable computed tomography (CT) scan, positron emission tomography computed tomography (PET-CT) scan, or MRI scan (e.g. scan of the chest, abdomen, or pelvis for any indication w/in 1 year) * Female * ≥ 18 years old * Adequate organ function to receive paclitaxel treatment as defined in the protocol * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Concomitant administration of any moderate or strong inducer or inhibitor of CYP2C8, including rifampin or clopidogrel. * History of hypersensitivity reaction to paclitaxel or any components of paclitaxel (e.g., Cremophor EL) that precludes continued treatment with standard dose and infusion length * Pregnant or nursing * Receiving any other dose (i.e., not 80 mg/m2) or infusion rate (i.e., not 60 minute infusion) either due to toxicity during a previous cycle or any other reason
Contact & Investigator
Daniel L Hertz, PharmD, PhD
PRINCIPAL INVESTIGATOR
University of Michigan Rogel Cancer Center
Frequently Asked Questions
Who can join the NCT05183126 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05183126 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05183126 currently recruiting?
Yes, NCT05183126 is actively recruiting participants. Contact the research team at CancerAnswerLine@med.umich.edu for enrollment information.
Where is the NCT05183126 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT05183126 clinical trial?
NCT05183126 is sponsored by University of Michigan Rogel Cancer Center. The principal investigator is Daniel L Hertz, PharmD, PhD at University of Michigan Rogel Cancer Center. The trial plans to enroll 22 participants.
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