Status:
COMPLETED
A Study Using Whole-body PET After Oral Microdose of 18F-labeled Liporaxel in Patients With Solid Tumor
Lead Sponsor:
Seoul National University Hospital
Conditions:
Solid Tumor
Eligibility:
All Genders
19+ years
Phase:
EARLY_PHASE1
Brief 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 1...
Detailed Description
The subject should be diagnosed as solid cancer on histopathology or cytology and should be more than 19 years old. Patients with progressed, metastatic, or recurrent disease despite standard therapie...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- The subject should be diagnosed as solid cancer on histopathology or cytology and should be more than 19 years old.
- Patients with progressed, metastatic, or recurrent disease despite standard therapies for solid tumors were included.
- The disease had to be measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- 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:
- 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.
- Patients with a history of adverse reactions and allergic reactions to paclitaxel or paclitaxel-like substances (e.g., taxol) were also excluded.
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
July 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2018
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04046016
Start Date
July 3 2018
End Date
December 24 2018
Last Update
August 6 2019
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam, Gyounggi, South Korea