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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04046016
• Other study ID #: DHP107_Bioimaging
• Status: Completed
• Phase: Early Phase 1
• Start date: July 3, 2018
• Est. completion date: December 24, 2018

Study information

• Verified date: August 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 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. 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.

Subjects eligible for the inclusion/exclusion criteria were orally administered Liporaxel solution 300 mg containing a microdose amount of 18F-Liporaxel on Visit 1. At 0, 2, 4, 8, 10 h post-dose, whole body PET/CT imaging (head-to-thigh) were obtained. Visit 2, 3, and 4 were taken 1, 2, and 3 weeks after Visit 1, respectively. For each visit, the adverse events, vital sign, physical examination, and clinical laboratory test results were evaluated and then therapeutic dose of Liporaxel was administered. Five weeks after Visit 1, the subject self-administered Liporaxel and adverse events and comedication were followed up by phone. At Visit 6, eight weeks after Visit 1, RECIST measurements were made with contrast-enhanced CT with safety evaluation. Tumor response was assessed to determine whether the study could be completed. If the tumor response was progression, the study was to be terminated. If stable disease, subject started a new cycle starting from Visit 6, and decided to evaluate tumor response with CT scan every eight week based on Visit 6. If the subject did not adequately recover from the hematologic and non-hematologic toxicities of Liporaxel during the entire study, the doses could be delated for up to two weeks at the discretion of the investigator. Exclusion was made in cases exceeding two weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 24, 2018
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• Paclitaxel
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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyounggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Plasma paclitaxel peak concentration	pre-dose, 2, 4, 6, 8, 10 hours after post-dose
Primary	AUClast	Plasma paclitaxel area under the time-concentration curve until the last measurable time point	pre-dose, 2, 4, 6, 8, 10 hours after post-dose