Food Effect on Pharmacokinetics and Safety of DHP107 (Liporaxel®) FEEL Study

NCT04675528 | Completed Phase 1 DMC

• 1 other identifier: 107CS-7
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the food effect on pharmacokinetics of DHP107 in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumor; Liporaxel; DHP107; Oral paclitaxel

Outcome Measures

Primary Outcomes (2)

• • Cmax

  The primary endpoints of this trial are the ratio of geometric means of the following pharmacokinetic parameters following DHP107 administration fed with fasting condition

  Day 1 and Day 8 of Cycle 1(each cycle is 28 days)

• • Tmax

  and the median difference of the following pharmacokinetic parameters following DHP107 administration fed with fasting condition:

  Day 1 and Day 8 of Cycle 1(each cycle is 28 days)

Study Arms (2)

Fasting treatment

EXPERIMENTAL

Drug: DHP107(Oral paclitaxel)

Fed treatment

EXPERIMENTAL

Drug: DHP107(Oral paclitaxel)

Interventions

DHP107(Oral paclitaxel) DRUG

DHP107 200 mg/m\^2 orally twice daily on Day 1, 8, and 15 in every 28 days (On food effect study day, DHP107 200 mg/m\^2 orally once daily on Day 1, 8 of Cycle 1 with fasted or fed condition according to the assigned sequence)

Also known as: Liporaxel®

Fasting treatment; Fed treatment

Eligibility Criteria

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

You may qualify if:

• Subjects who are ≥18 years of age on the date of written informed consent.
• Subjects with histologically or cytologically confirmed advanced solid tumors including but not limited to the listed below for which paclitaxel monotherapy has been determined an appropriate therapy at the investigator's discretion.
• Angiosarcoma
• Bladder cancer
• Breast cancer
• Cervical cancer
• Head and neck cancer (if no difficulty with swallowing)
• Kaposi's sarcoma
• Lung cancer
• Ovarian cancer
• Subjects who have a life expectancy of ≥12 weeks.
• Subjects who are able to take oral medication.
• Subjects who have a performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Subjects who have evaluable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).
• Subjects who have adequate organ functions as indicated by the following laboratory values:

You may not qualify if:

• Subjects who have history of severe hypersensitive reaction to the active ingredient or any excipients of DHP107.
• Subjects with following surgical history/medical conditions that may affect drug absorption:
• Subjects who developed cardiovascular disease (unstable angina, myocardial infarction, stroke, and transient ischemic attack) within 24 weeks prior to study entry, which is deemed to be clinically significant by the investigator.
• Subjects with known active hepatitis B or C infection, or hepatobiliary disease, or known history of immunodeficiency virus infection (However, subjects with Gilbert's Syndrome, asymptomatic gallstones, or stable chronic liver disease are, at the discretion of the investigator, eligible for the study. Subjects who are hepatitis B carriers may be eligible if they are on antiviral therapy 2 weeks prior to study entry).
• Subjects with neuropathy grade \> 2 based on CTCAE v5.0 at the time of study entry.
• Subjects with uncontrolled medical or mental illness that, in the investigator's judgement, could affect treatment tolerability or compliance.
• Subjects diagnosed with other malignant primary tumor with an exception of the following:
• Malignancy diagnosed at least 5 years previously without evidence of recurrence or persistent disease
• The complete excision of basal/squamous cell carcinoma or papillary thyroid carcinoma or the complete treatment of cervical intraepithelial neoplasia or other in situ carcinoma
• Subjects with symptomatic or unstable, untreated metastases to the central nervous system (CNS) at the time of screening ('Unstable' means worsening of symptoms within 4 weeks prior to screening).
• Subjects who are currently receiving alternative cytotoxic agents, regular systemic corticosteroids and medications that could influence drug absorption (e.g. H2-antihistamines, antacids, metoclopramide and charcoal) within 4 weeks prior to entry into the study (C1D1).
• Subjects who are currently receiving (or unable to stop use the 3 days before the first dose of DHP107 and throughout the study) prescription or non-prescription medications or other products known to be moderate or potent inhibitors/inducers of CYP3A4, P-gp, or CYP2C8.
• Subjects who cannot intake whole high fat meal offered.
• Pregnant or breastfeeding women.
• Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1)

Sponsors & Collaborators

• Daehwa Pharmaceutical Co., Ltd.: lead

Study Sites (5)

University of Semmelweis, 1st Internal Medicine Clinic, Department of Clinical Pharmacology

Budapest, 1083, Hungary

Location

National Institute of Oncology

Budapest, 1122, Hungary

Location

University of Debrecen-Clinical Center, Internal Medicine Clinic, Department of Clinical Pharmacology

Debrecen, 4032, Hungary

Location

Clinexpert Ltd Phase I. Studycenter

Gyöngyös, 3200, Hungary

Location

University of Szeged, Dermatology and Allergology Clinic, Phase I. Investigational site

Szeged, 6720, Hungary

Location

Study Officials

• Erika Hitre, M.D., Ph.D

  National Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, open-label, two-way crossover study consisting of two sequences (RT, TR) in patients with advanced solid tumor.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 19, 2020
• Study Start: May 4, 2021
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: July 25, 2024

Record last verified: 2022-01

Locations

HU (5)