Solid Tumor, AdultPhase 1NCT03892018
The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
A Phase 1 study testing Oraxol in people with Solid Tumor, Adult, run by Athenex, Inc. at 3 sites in United Kingdom.
Trial summary
This is multicenter, open-label, 2-part crossover study. Eligible subjects will have metastatic or unresectable solid tumors. This study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Oraxol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 5 Aug 2019to 12 May 2023
- 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
- Signed written informed consent
- Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Measurable disease as per RECIST v1.1 criteria
- Adequate hematologic status
- Adequate liver function.
- Adequate renal function
Show all 11Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months.
- Women must be postmenopausal or surgically sterile.
- Sexually active male subjects must use a barrier method of contraception during the study.
- Able to consume the prescribed meals
Who cannot join
- Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs).
- Received IPs within 21 days or 5 half-lives of the first dosing day, whichever is shorter
- Are currently receiving other medications or radiation intended for the treatment of their malignancy. Hormonal therapy is allowed.
- Women of childbearing potential who are pregnant or breastfeeding.
- Currently taking a concomitant medication, other than a premedication, that is:
- A strong P-glycoprotein (P-gp) inhibitor or inducer.
Show all 12Show fewer
- An oral medication with a narrow therapeutic index known to be a P-gp substrate.
- Medications known to be strong inhibitors or inducers of cytochrome P450 (CYP) 2C8 or medications known to be strong CYP3A4 inhibitors or inducers.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or any concomitant illness that would limit compliance with study requirements.
- Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease that may interfere with oral drug absorption.
- Cirrhosis of the liver or known active hepatitis B, hepatitis C, or HIV
- History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity-type reaction to Cremophor
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
The Beatson West of Scotland Cancer Care Centre
Glasgow, G12 0YN
The Christie NHS Foundation Trust
Manchester, M20 4BX
The Northern Institute for Cancer Care
Newcastle upon Tyne, NE2 4HH
About this study
Official title: An Open-label, Crossover Study of the Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
This is multicenter, open-label, 2-part crossover study. Eligible subjects will have metastatic or unresectable solid tumors. This study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline. The treatment phase consists of Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up.
- Conditions
- Solid Tumor, Adult
- Being tested
- Oraxol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraxolDrug
Also called Paclitaxel and HM30181AK-US
Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.
| Study group | Role | What they receive |
|---|---|---|
| Fed/ Fasted Treatment Sequence | Active comparator | Subjects will be assigned a fed/fasted sequence.
Fed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration.
Fasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose. Receives: Drug: Oraxol |
| Fasted/ Fed Treatment Sequence | Active comparator | Subjects will be assigned a fasted/fed sequence.
Fasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose.
Fed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration. Receives: Drug: Oraxol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the concentration-time profile of Oral Paclitaxel in plasma for 168 hours when taken with or without food.
Measured: 24 months
Secondary outcomes (3)
Comparison of the concentration-time profile of HM30181 in plasma for 168 hours when taken with or without food.
Measured: 24 months
The proportion of patients with tumor responses after the initiation of treatment.
RECIST v1.1 criteria defined as complete response, partial response, stable disease or progressive disease
Measured: At baseline and every 8 weeks through study completion, approximately 24 months
Incidence of Adverse Events (Safety and Tolerability)
Evaluate the safety of Oraxol. Number of participants with treatment-related adverse events.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start5 Aug 2019
- Primary completion12 May 2023
- Study completion12 May 2023
Why it stopped: STUDY HALTED DUE TO FINANCIAL CONTRAINTS
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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 will be an open-label, 2-part, crossover study to assess the effect of food on Oraxol exposure. The study will consist of the following periods: Screening, Baseline, Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up. Part A will assess the effect of food on Oraxol pharmacokinetics. In Part A, subjects will be randomized to the sequence (fed/fasted or fasted/fed conditions) under which they will be administered single-dose treatment after an overnight fast. There will be a minimum of 7 days after Period 1 treatment before subjects cross over to Period 2 treatment. Subjects who have participated in the PK assessments in Part A of the study may continue into Part B, during which Oraxol will be dosed for 3 consecutive days per week under fasting conditions.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Cutler, MD, Study director, Athenex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892018
- Sponsor's protocol ID
- KX-ORAX-012
- Status last verified
- Oct 2022
- First submitted
- 19 Mar 2019
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Crossover Study of the Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
- ClinicalTrials.gov ID
- NCT03892018
- Acronym / sponsor ID
- KX-ORAX-012
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: STUDY HALTED DUE TO FINANCIAL CONTRAINTS
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 27 Mar 2019 (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.
This is multicenter, open-label, 2-part crossover study. Eligible subjects will have metastatic or unresectable solid tumors. This study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline. The treatment phase consists of Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be an open-label, 2-part, crossover study to assess the effect of food on Oraxol exposure. The study will consist of the following periods: Screening, Baseline, Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up. Part A will assess the effect of food on Oraxol pharmacokinetics. In Part A, subjects will be randomized to the sequence (fed/fasted or fasted/fed conditions) under which they will be administered single-dose treatment after an overnight fast. There will be a minimum of 7 days after Period 1 treatment before subjects cross over to Period 2 treatment. Subjects who have participated in the PK assessments in Part A of the study may continue into Part B, during which Oraxol will be dosed for 3 consecutive days per week under fasting conditions.
| Arm | Type | Receives |
|---|---|---|
| Fed/ Fasted Treatment Sequence | Active comparator | Drug: OraxolSubjects will be assigned a fed/fasted sequence. Fed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration. Fasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose. |
| Fasted/ Fed Treatment Sequence | Active comparator | Drug: OraxolSubjects will be assigned a fasted/fed sequence. Fasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose. Fed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent
- Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Measurable disease as per RECIST v1.1 criteria
- Adequate hematologic status
- Adequate liver function.
Key exclusion criteria (12 listed)
- Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs).
- Received IPs within 21 days or 5 half-lives of the first dosing day, whichever is shorter
- Are currently receiving other medications or radiation intended for the treatment of their malignancy. Hormonal therapy is allowed.
- Women of childbearing potential who are pregnant or breastfeeding.
- Currently taking a concomitant medication, other than a premedication, that is:
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 |
|---|---|---|
| OraxolAlso: Paclitaxel and HM30181AK-USOraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets. | Drug | Fasted/ Fed Treatment Sequence, Fed/ Fasted Treatment Sequence |
Primary outcome
Comparison of the concentration-time profile of Oral Paclitaxel in plasma for 168 hours when taken with or without food.
Time frame: 24 months
3 secondary outcomes
Comparison of the concentration-time profile of HM30181 in plasma for 168 hours when taken with or without food.
Time frame: 24 months
The proportion of patients with tumor responses after the initiation of treatment.
Time frame: At baseline and every 8 weeks through study completion, approximately 24 months
Incidence of Adverse Events (Safety and Tolerability)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: STUDY HALTED DUE TO FINANCIAL CONTRAINTS). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor, Adult
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
David Cutler, MD study director
Athenex, Inc.
3 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 Oraxol in people with Solid Tumor, Adult, run by Athenex, Inc. at 3 sites in United Kingdom.
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 11 inclusion and 12 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: stopped early, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 was stopped early (reason given: STUDY HALTED DUE TO FINANCIAL CONTRAINTS). Results are not available in the source record.
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?
Comparison of the concentration-time profile of Oral Paclitaxel in plasma for 168 hours when taken with or without food. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.