Clinical trial · Interventional
Pharmacokinetics Study of Liposomal Paclitaxel in Humans
A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans
NCT00606515CI-TRIAL-00002036LPS-PK-HcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal paclitaxel | Drug | Paclitaxel Liposome | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Liposomal paclitaxel
- interventionNames
- Drug: Liposomal paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Paclitaxel
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Pharmacokinetic parameters
- timeFrame
- 72 hours after the infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible patients must have histologically confirmed solid tumors of advanced stages * Patients who are suitable for being treated with liposomal paclitaxel only * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 * Patients who are expected to be alive for at least 3 months * Adequate hematologic, hepatic and renal functions * Adequate other organ functions as defined by the protocol * No prior systemic chemotherapy at least 4 weeks before the recruitment * No previous anaphylactic reaction to hormone. Exclusion Criteria: * Allergy to any study medication * Serious complication that would compromise the patient's ability to complete the study * Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria * Pregnancy or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.