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

NCT04046016 | Completed Early Phase 1

• 1 other identifier: DHP107_Bioimaging
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 18F-Liporaxel was 0.98-2.9 μg (185-555 MBq).

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Cmax

  Plasma paclitaxel peak concentration

  pre-dose, 2, 4, 6, 8, 10 hours after post-dose

• 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

Study Arms (1)

Subjects

EXPERIMENTAL

A total of two subjects were enrolled. Those are breast cancer patients.

Drug: Paclitaxel

Interventions

Paclitaxel DRUG

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).

Also known as: Liporaxel

Subjects

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyounggi, South Korea

Location

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Howard Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: August 6, 2019
• Study Start: July 3, 2018
• Primary Completion: December 24, 2018
• Study Completion: December 24, 2018
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)