Clinical trial · Interventional
A Study Using Whole-body PET After Oral Microdose of 18F-labeled Liporaxel in Patients With Solid Tumor
A Phase 0 Study to Investigate Biodistribution and Target Tissue Distribution Using Whole-body PET Scan After Oral Administration of Therapeutic Dose of Liporaxel Solution and Microdose of 18F-labeled Liporaxel in Patients With Solid Tumor
- 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)
An open-label, single oral dose of therapeutic Liporaxel and microdose 18F-Liporaxel administration study was conducted in two breast cancer patients. Therapeutic dose of Liporaxel was 200 mg/m2 and 18F-Liporaxel was 0.98-2.9 μg (185-555 MBq).
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Subjects
- description
- A total of two subjects were enrolled. Those are breast cancer patients.
- interventionNames
- Drug: Paclitaxel
Primary outcomes (2)
- measure
- Cmax
- timeFrame
- pre-dose, 2, 4, 6, 8, 10 hours after post-dose
- description
- Plasma paclitaxel peak concentration
- measure
- AUClast
- timeFrame
- pre-dose, 2, 4, 6, 8, 10 hours after post-dose
- description
- Plasma paclitaxel area under the time-concentration curve until the last measurable time point
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion criteria: 1. The subject should be diagnosed as solid cancer on histopathology or cytology and should be more than 19 years old. 2. Patients with progressed, metastatic, or recurrent disease despite standard therapies for solid tumors were included. 3. The disease had to be measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 4. The Eastern Cooperative Oncology Group (ECOG) performance status should be less than 2 and the predicted survival time should be more than 12 weeks. Exclusion criteria: 1. Those who were not able to take the oral medication or who had an operation that could lead to abnormal bile acid secretion were excluded. 2. Patients with a history of adverse reactions and allergic reactions to paclitaxel or paclitaxel-like substances (e.g., taxol) were also excluded. 3. Patients who are taking P-glycoprotein inducers or inhibitors or drugs which is known to exist drug-drug interaction with paclitaxel (e.g., cyclosporine A, ketoconazole, rifampicin, clarithromycin) were excluded. 4. Patients with a neutrophil count less than 1,500 cell/mm3, platelet count less than 100,000 cells/mm3, and with infectious diseases at the beginning of the study were excluded.
References
Publications (0)
Data not yet available