Clinical trial · Interventional
Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Normal SMA (>7310 mm^2)
- description
- Standard paclitaxel infusion time.
- interventionNames
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2)
- description
- Adjusted paclitaxel infusion time during only one dose; standard paclitaxel infusion time for all other doses.
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Maximum concentration (Cmax) of paclitaxel plasma
- timeFrame
- Up to week 12
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available