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

July 24, 2024 updated by: Daehwa Pharmaceutical Co., Ltd.

A Randomized, Open-label, Two-way Crossover Clinical Trial to Evaluate the Food Effect on Pharmacokinetics and SafEty of DHP107 (Oral Paclitaxel, Liporaxel®) in Patients With Advanced Solid Tumors (FEEL) / EudraCT no : 2020-004976-16

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Erika Hitre, M.D., Ph.D
  • Phone Number: +36-1-22-48-763
  • Email: hitre@oncol.hu

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • National Institute of Oncology
      • Budapest, Hungary, 1083
        • University of Semmelweis, 1st Internal Medicine Clinic, Department of Clinical Pharmacology
      • Debrecen, Hungary, 4032
        • University of Debrecen-Clinical Center, Internal Medicine Clinic, Department of Clinical Pharmacology
      • Gyöngyös, Hungary, 3200
        • Clinexpert Ltd Phase I. Studycenter
      • Szeged, Hungary, 6720
        • University of Szeged, Dermatology and Allergology Clinic, Phase I. Investigational site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects who are ≥18 years of age on the date of written informed consent.

  2. 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
  3. Subjects who have a life expectancy of ≥12 weeks.
  4. Subjects who are able to take oral medication.
  5. Subjects who have a performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
  6. Subjects who have evaluable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).
  7. Subjects who have adequate organ functions as indicated by the following laboratory values:
  8. Subjects who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and procedures.
  9. Subjects who have voluntarily agreed to participate by giving written informed consent.
  10. Women of childbearing potential who have negative pregnancy test results at the screening visit and men with female partners of childbearing potential must agree to use adequate contraception for the duration of the trial and up to 90 days after last dose of study drug

Exclusion Criteria:

  1. Subjects who have history of severe hypersensitive reaction to the active ingredient or any excipients of DHP107.
  2. Subjects with following surgical history/medical conditions that may affect drug absorption:
  3. 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.
  4. 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).
  5. Subjects with neuropathy grade > 2 based on CTCAE v5.0 at the time of study entry.
  6. Subjects with uncontrolled medical or mental illness that, in the investigator's judgement, could affect treatment tolerability or compliance.

  7. 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
  8. 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).
  9. 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).
  10. 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.
  11. Subjects who cannot intake whole high fat meal offered.
  12. Pregnant or breastfeeding women.
  13. Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fasting treatment
Drug: DHP107(Oral paclitaxel)
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)
Other Names:
  • Liporaxel®
Experimental: Fed treatment
Drug: DHP107(Oral paclitaxel)
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)
Other Names:
  • Liporaxel®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
• Cmax
Time Frame: Day 1 and Day 8 of Cycle 1(each cycle is 28 days)
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
Time Frame: Day 1 and Day 8 of Cycle 1(each cycle is 28 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daehwa Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erika Hitre, M.D., Ph.D, National Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 107CS-7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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