A Study Using Whole-body PET After Oral Microdose of 18F-labeled Liporaxel in Patients With Solid Tumor

• Status: Completed
• Trial end date: 2018-12-24
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Paclitaxel

Criteria

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.