Advanced Solid TumorPhase 1FEELNCT04675528
Food Effect on Pharmacokinetics and Safety of DHP107 (Liporaxel®) FEEL Study
A Phase 1 study testing DHP107(Oral paclitaxel) in people with Advanced Solid Tumor, run by Daehwa Pharmaceutical Co., Ltd. at 5 sites in Hungary.
Trial summary
To evaluate the food effect on pharmacokinetics of DHP107 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- DHP107(Oral paclitaxel)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesHungary
- Study dates
- 4 May 2021to 12 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- Subjects who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and procedures.
- Subjects who have voluntarily agreed to participate by giving written informed consent.
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Hungary5 sites
University of Semmelweis, 1st Internal Medicine Clinic, Department of Clinical Pharmacology
Budapest, 1083
National Institute of Oncology
Budapest, 1122
University of Debrecen-Clinical Center, Internal Medicine Clinic, Department of Clinical Pharmacology
Debrecen, 4032
Clinexpert Ltd Phase I. Studycenter
Gyöngyös, 3200
University of Szeged, Dermatology and Allergology Clinic, Phase I. Investigational site
Szeged, 6720
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- DHP107(Oral paclitaxel)
- Keywords
- Advanced Solid Tumor, Liporaxel, DHP107, Oral paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHP107(Oral paclitaxel)Drug
Also called Liporaxel®
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)
| Study group | Role | What they receive |
|---|---|---|
| Fasting treatment | Experimental | Not described Receives: Drug: DHP107(Oral paclitaxel) |
| Fed treatment | Experimental | Not described Receives: Drug: DHP107(Oral paclitaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: 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:
Measured: Day 1 and Day 8 of Cycle 1(each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start4 May 2021
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, open-label, two-way crossover study consisting of two sequences (RT, TR) in patients with advanced solid tumor.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daehwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erika Hitre, M.D., Ph.D, Principal investigator, National Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675528
- Sponsor's protocol ID
- 107CS-7
- Acronym
- FEEL
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2020
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hitre E, Lang I, Pall D. A randomized, open-label, two-way crossover clinical trial to evaluate the food effect on pharmacokinetics and safety of DHP107 in patients with advanced solid tumors: the FEEL study. Cancer Chemother Pharmacol. 2026 May 30;96(1):59. doi: 10.1007/s00280-026-04887-9.
PubMed 42215716
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04675528
- Acronym / sponsor ID
- FEEL / 107CS-7
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumor, Liporaxel, DHP107, Oral paclitaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Daehwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 May 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the food effect on pharmacokinetics of DHP107 in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, open-label, two-way crossover study consisting of two sequences (RT, TR) in patients with advanced solid tumor.
| Arm | Type | Receives |
|---|---|---|
| Fasting treatment | Experimental | Drug: DHP107(Oral paclitaxel) |
| Fed treatment | Experimental | Drug: DHP107(Oral paclitaxel) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHP107(Oral paclitaxel)Also: Liporaxel®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) | Drug | Fasting treatment, Fed treatment |
Primary outcome
• 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
• 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:
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Derived from this study: PubMed 42215716Hitre E, Lang I, Pall D. A randomized, open-label, two-way crossover clinical trial to evaluate the food effect on pharmacokinetics and safety of DHP107 in patients with advanced solid tumors: the FEEL study. Cancer Chemother Pharmacol. 2026 May 30;96(1):59. doi: 10.1007/s00280-026-04887-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Hitre, M.D., Ph.D principal investigator
National Institute of Oncology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DHP107(Oral paclitaxel) in people with Advanced Solid Tumor, run by Daehwa Pharmaceutical Co., Ltd. at 5 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Cmax (time frame: Day 1 and Day 8 of Cycle 1(each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04675528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.