Metastatic Breast CancerPhase 1NCT07580833
A Study to Investigate the Effect of Food on the Bioavailability of Oral Paclitaxel Administered With Encequidar in Participants With Advanced Solid Tumors
A Phase 1 study testing Oral Paclitaxel in combination with Encequidar tablet in people with Metastatic Breast Cancer, run by Health Hope Pharma.
Trial summary
The goal of this clinical trial is to learn about the effect of food on absorption of oral Paclitaxel when co- administered with Encequidar tablets in adult patients with tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Oral Paclitaxel in combination with Encequidar tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- ≥18 years of age
- Cancer patients for whom treatment with paclitaxel monotherapy is a reasonable therapeutic option, including but not limited to: advanced or metastatic breast cancer, gastric cancer (who have not undergone gastric resection surgery), non-small cell lung cancer, or ovarian cancer.
- 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 and for which oral paclitaxel is a reasonable treatment. Participants who are intolerant of standard-of-care treatment or declined standard-of-care treatment may be enrolled.
- Adequate hematologic status as demonstrated by not requiring granulocyte colony stimulating factor (G-CSF) or transfusion support within 30 days prior to randomization to achieve the following at Screening/Baseline:
- Absolute neutrophil count (ANC) ≥1.5 × 109/L
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- Platelet count ≥100 × 109/L
- Hemoglobin ≥10 g/dL
- Adequate liver function at Screening/Baseline as demonstrated by:
- Total bilirubin ≤ upper limit of normal (ULN) unless the participant has documented Gilbert's disease, for which bilirubin must be ≤2.0 × ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN
- Adequate renal function at Screening/Baseline as demonstrated by estimated glomerular filtration rate (eGFR) ≥60 mL/min.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Able to fast for 10 hours before and 4 hours after oPac+E administration.
- Women must be postmenopausal (≥12 months without menses) or surgically sterile (i.e. by hysterectomy and/or bilateral oophorectomy) or, must be using effective contraception (i.e. non hormonal intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 4 months after their last dose of study drug.
- Sexually active male participants must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 4 months after the last dose of study drug.
- Able to consume the prescribed meals.
- Adequate venous access for PK sampling.
Who cannot join
- Not recovered to grade ≤1 toxicity from previous anticancer treatments or previous investigational products (IPs); exception to this is alopecia or lymphopenia.
- Received IPs within 21 days or 5 half-lives of the first dosing day, whichever is shorter.
- 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.
- Taking a medication known to be a moderate or strong cytochrome P450 (CYP) 3A4 inhibitor or inducer or neurokinin-1 receptor antagonist (NK-1) inhibitor within 14 days prior to start of dosing.
- Taking a medication known to be a moderate or strong CYP2C8 inhibitor or inducer within 14 days prior to start of dosing.
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- Taking an oral medication with a narrow therapeutic index known to be a P-glycoprotein (P-gp) substrate within 24 hours prior to start of dosing.
- Taking a medication known to be a P-gp inhibitor or inducer within 14 days prior to start of dosing in the study.
- Taking a medication known to be an organic anion transporting polypeptide 1B1/3 (OATP1B1/3) inhibitor.
- Require therapeutic use of warfarin. Participants receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the investigator, may be enrolled provided they are switched to low molecular weight heparin at least 1 week before receiving study treatment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements.
- Major surgery to the upper gastrointestinal (GI) tract, or a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption.
- Cirrhosis of the liver or active hepatitis B or C. Enrollment of treated patients with hepatitis B or C are permitted, provided that (a) participant with chronic HBV is on anti-HBV prophylaxis, if needed based on the risk of reactivation (b) participants with HCV who had curative treatment are required to have a viral load that is below the level of quantification. A participant who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution should be eligible.
- Participants with known active HIV. Treated HIV participants who are on a stable antiretroviral treatment regimen for at least 4 weeks prior to enrollment, with a documented viral load < 400 copies/mL are permitted.
- History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity-type reaction to Cremophor.
- History of hypersensitivity to any of the excipients in encequidar tablets or oral paclitaxel.
- History of lactose intolerance.
About this study
The goal of this clinical trial is to learn about the effect of food on absorption of oral Paclitaxel when co- administered with Encequidar tablets in adult patients with tumours.
The main questions it aims to answer are:
Read more
- The effect of food and fasting on absorption of oral paclitaxel when combined with Encequidar tablets
- Assessment of safety and tolerability of oral paclitaxel when combined with Encequidar tablets
Participants will take Encequidar and oral paclitaxcel with a 1-hour space in between, either after an overnight fast of 10hours or after a meal three days in a row. After 10 days participants that received paclitaxel after fasting will receive the same medicine in the same way after a meal and vice versa. Some participants can elect to take part in the third part of the study which involves taking both paclitaxel and encequidar at the same time after a meal.
Participants will
- For parts 1,2 and 3 participants will stay at the clinic from the day before the study starts until day 4 to receive the medicine and participate in checkups and tests. Participants will then visit the clinic on day 6 and 8 for further checkups and tests
Read the detailed description
Study Design:
This is a randomized, balanced, multidose, 2-period, two-way (i.e., fed versus fasted), crossover design to examine the effect of food on paclitaxel bioavailability when administered as oPac+E to eligible participants. After completion of the two-way cross over periods, a subset of participants will receive concurrent encequidar and oral paclitaxel capsules after a low-fat meal in Period 3, which is a nonrandomized single arm. Following the Food Effect Part, continued treatment will be offered in the Treatment Part of the study for all participants who complete the Food Effect Part.
In the Food Effect Part (two-way crossover), approximately 46 participants will be randomized. After participants have finished Period 2, they will be asked if they feel comfortable entering Period 3. Enrollment of participants into Period 3 will stop after 8 participants have been enrolled. In the Food Effect Part, an unexpected serious adverse reaction that results in death will be used as stopping criteria for safety that will trigger suspension of enrollment to allow for a detailed safety review. Participants who do not participate in Period 3 will enter into the Treatment Part following Period 2. The Food Effect Part will include Screening, Baseline, Treatment, and safety follow-up.
Food Effect Part:
In the Food Effect Part (randomized 2-period, two-way crossover), participants will receive oPac+E in 2 sequences (fed/fasted or fasted/fed) in which encequidar is administered 1 hour before the oral paclitaxel capsules. A treatment of oPac+E consisting of 3 daily doses will be administered on 3 consecutive days in each period. In Period 3, participants will receive concurrent administration of encequidar and oral paclitaxel after a low-fat meal. As patients with metastatic cancer frequently have decreased appetite and may have difficulty eating a high-fat meal, the Food Effect Part will be conducted using the Food and Drug Administration (FDA) recommended low-fat meal as per the FDA Guidance for Industry "Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations 2022". Participants will be randomized to the sequence under which they will be administered oPac+E following an overnight fast of at least 10 hours. In each period, participants will be housed in the clinic from Day -1 until after collection of the 72-hour PK sample on Day 4. Participants will then return to the clinic for additional PK sample collections at designated time points on Days 6 and 8. There will be a washout of at least 10 days after the last dose between periods to minimize carryover, based on the estimated half-life (43 hours) of paclitaxel. The oral paclitaxel dose should remain unchanged (total mg dose) during the Food Effect Part of the trial. Period 2 may be delayed up to 3 weeks to allow recovery from toxicity which interrupted treatment or up to 4 weeks to allow flexibility to schedule inpatient treatment. A final visit will occur on the last day of PK sampling or up to 2 weeks after the end of PK sampling.
Period 3 will begin at least 10 days after the last dose in Period 2. Participants will be housed in the clinic from Day -1 until after collection of the 72 hours PK sample on Day 4. Participants will then return to the clinic for additional PK sample collections at designated time points on Days 6 and 8. A final visit will occur on the last day of PK sampling or up to 2 weeks after the end of PK sampling. Participants who discontinue prior to completion of the Food Effect Part will be followed for ongoing or new AE/SAEs until 30 days after the last dose or resolution/stabilization. Participants who successfully complete the Food Effect Part will be offered treatment with oPac+E in the Treatment Part of this protocol to further evaluate oPac+E safety.
Treatment Part:
In the Treatment Part, oPac+E will be administered on an empty stomach at a dose of 205 mg/m2/day for 3 consecutive days per week for 3 weeks of a 4-week cycle, a dose and regimen being used in the ongoing oPac+E development program. Participants who experience toxicity may continue treatment with dose modifications (dose reduction, dose delay) as allowed during management of common paclitaxel toxicity, if considered appropriate by the investigator. oPac+E treatment will be discontinued in participants who did not recover within 3 weeks from oral paclitaxel toxicity that interrupted treatment. Participants in the Treatment Part will continue receiving cycles of treatment until they meet protocol-specified discontinuation criteria or the investigator is of the opinion that the participant is no longer benefitting from treatment and enter the safety follow-up. CT scans will be performed for surveillance of disease every 8 weeks. oPac+E treatment will be stopped if there is disease progression. During the safety follow-up, participants will be followed for 30 days after their last dose. A final visit will occur at the last clinic visit or up to 30 days after the last dose administered.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Oral Paclitaxel in combination with Encequidar tablet
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Paclitaxel in combination with Encequidar tabletDrug
Participant is either fasted or fed when taking Oral Paclitaxel in combination with Encequidar tablet
| Study group | Role | What they receive |
|---|---|---|
| The Effect of Food on the Bioavailability of Oral Paclitaxel Administered with Encequidar | Experimental | The Food Effect study (randomized 2-period, two-way crossover), participants will receive oPac+E in 2 sequences (fed/fasted or fasted/fed) in which encequidar is administered 1 hour before the oral paclitaxel capsules. A treatment of oPac+E consisting of 3 daily doses will be administered on 3 consecutive days in each period 1 and 2. In Period 3, participants will receive concurrent administration of encequidar and oral paclitaxel after a low-fat meal. Receives: Drug: Oral Paclitaxel in combination with Encequidar tablet |
| The Effect of Fasting on the Bioavailability of Oral Paclitaxel Administered with Encequidar | Experimental | The Food Effect study (randomized 2-period, two-way crossover), participants will receive oPac+E in 2 sequences (fed/fasted or fasted/fed) in which encequidar is administered 1 hour before the oral paclitaxel capsules. A treatment of oPac+E consisting of 3 daily doses will be administered on 3 consecutive days in each period 1 and 2. In Period 3, participants will receive concurrent administration of encequidar and oral paclitaxel after a low-fat meal. Receives: Drug: Oral Paclitaxel in combination with Encequidar tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-t) and AUC from time 0 to infinity (AUC0-INF) of oral paclitaxel when paclitaxel is administered one hour following encequidar.
The bioavailability of oral paclitaxel, measured by AUC0-t and AUC0-INF, will be determined after oral paclitaxel is administered one hour following encequidar dosing under both fed and fasting conditions. AUC0-t will be calculated using trapezoidal rule. AUC0-INF will be calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Measured: Plasma sample collected from pre-dose on Day 1 to Day 8.
Secondary outcomes (2)
Number of participants with treatment emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Safety and tolerability will be evaluated in terms of treatment emergent AEs and serious adverse events. This includes the types, incidence and severity of treatment emergent adverse events, as well as clinically significant abnormal laboratory test results, abnormal physical examination findings, abnormal vital signs, and abnormal electrocardiogram QT interval that emerge after treatment. Clinical and laboratory adverse events will be primarily graded using NCI CTCAE Version 5.0.
Measured: From screening to the final follow-up visit.
Maximum observed concentration (Cmax) of oral paclitaxel when paclitaxel is administered one hour following encequidar.
The bioavailability of oral paclitaxel, measured by Cmax, will be determined after oral paclitaxel is administered one hour following encequidar dosing under both fed and fasting conditions.
Measured: Plasma sample collected from pre-dose on Day 1 to Day 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies 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, balanced, multidose, 2-period, two-way (i.e., fed versus fasted), crossover design to examine the effect of food on paclitaxel bioavailability when administered as oPac+E to eligible participants. After completion of the two-way cross over periods, a subset of participants will receive concurrent encequidar and oral paclitaxel capsules after a low-fat meal in Period 3, which is a nonrandomized single arm. Following the Food Effect Part, continued treatment will be offered in the Treatment Part of the study for all participants who complete the Food Effect Part. In the Food Effect Part (two-way crossover), approximately 46 participants will be randomized. After participants have finished Period 2, they will be asked if they feel comfortable entering Period 3. Enrollment of participants into Period 3 will stop after 8 participants have been enrolled.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Hope Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580833
- Sponsor's protocol ID
- HHP-ORAX-100
- Status last verified
- May 2026
- First submitted
- 24 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effect of Food on the Bioavailability of Oral Paclitaxel Administered With Encequidar in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07580833
- Acronym / sponsor ID
- HHP-ORAX-100
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Health Hope PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 May 2026 (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.
The goal of this clinical trial is to learn about the effect of food on absorption of oral Paclitaxel when co- administered with Encequidar tablets in adult patients with tumours.
The main questions it aims to answer are:
- The effect of food and fasting on absorption of oral paclitaxel when combined with Encequidar tablets
- Assessment of safety and tolerability of oral paclitaxel when combined with Encequidar tablets
Participants will take Encequidar and oral paclitaxcel with a 1-hour space in between, either after an overnight fast of 10hours or after a meal three days in a row. After 10 days participants that received paclitaxel after fasting will receive the same medicine in the same way after a meal and vice versa. Some participants can elect to take part in the third part of the study which involves taking both paclitaxel and encequidar at the same time after a meal.
Participants will
- For parts 1,2 and 3 participants will stay at the clinic from the day before the study starts until day 4 to receive the medicine and participate in checkups and tests. Participants will then visit the clinic on day 6 and 8 for further checkups and tests
Detailed description
Study Design:
This is a randomized, balanced, multidose, 2-period, two-way (i.e., fed versus fasted), crossover design to examine the effect of food on paclitaxel bioavailability when administered as oPac+E to eligible participants. After completion of the two-way cross over periods, a subset of participants will receive concurrent encequidar and oral paclitaxel capsules after a low-fat meal in Period 3, which is a nonrandomized single arm. Following the Food Effect Part, continued treatment will be offered in the Treatment Part of the study for all participants who complete the Food Effect Part.
In the Food Effect Part (two-way crossover), approximately 46 participants will be randomized. After participants have finished Period 2, they will be asked if they feel comfortable entering Period 3. Enrollment of participants into Period 3 will stop after 8 participants have been enrolled. In the Food Effect Part, an unexpected serious adverse reaction that results in death will be used as stopping criteria for safety that will trigger suspension of enrollment to allow for a detailed safety review. Participants who do not participate in Period 3 will enter into the Treatment Part following Period 2. The Food Effect Part will include Screening, Baseline, Treatment, and safety follow-up.
Food Effect Part:
In the Food Effect Part (randomized 2-period, two-way crossover), participants will receive oPac+E in 2 sequences (fed/fasted or fasted/fed) in which encequidar is administered 1 hour before the oral paclitaxel capsules. A treatment of oPac+E consisting of 3 daily doses will be administered on 3 consecutive days in each period. In Period 3, participants will receive concurrent administration of encequidar and oral paclitaxel after a low-fat meal. As patients with metastatic cancer frequently have decreased appetite and may have difficulty eating a high-fat meal, the Food Effect Part will be conducted using the Food and Drug Administration (FDA) recommended low-fat meal as per the FDA Guidance for Industry "Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations 2022". Participants will be randomized to the sequence under which they will be administered oPac+E following an overnight fast of at least 10 hours. In each period, participants will be housed in the clinic from Day -1 until after collection of the 72-hour PK sample on Day 4. Participants will then return to the clinic for additional PK sample collections at designated time points on Days 6 and 8. There will be a washout of at least 10 days after the last dose between periods to minimize carryover, based on the estimated half-life (43 hours) of paclitaxel. The oral paclitaxel dose should remain unchanged (total mg dose) during the Food Effect Part of the trial. Period 2 may be delayed up to 3 weeks to allow recovery from toxicity which interrupted treatment or up to 4 weeks to allow flexibility to schedule inpatient treatment. A final visit will occur on the last day of PK sampling or up to 2 weeks after the end of PK sampling.
Period 3 will begin at least 10 days after the last dose in Period 2. Participants will be housed in the clinic from Day -1 until after collection of the 72 hours PK sample on Day 4. Participants will then return to the clinic for additional PK sample collections at designated time points on Days 6 and 8. A final visit will occur on the last day of PK sampling or up to 2 weeks after the end of PK sampling. Participants who discontinue prior to completion of the Food Effect Part will be followed for ongoing or new AE/SAEs until 30 days after the last dose or resolution/stabilization. Participants who successfully complete the Food Effect Part will be offered treatment with oPac+E in the Treatment Part of this protocol to further evaluate oPac+E safety.
Treatment Part:
In the Treatment Part, oPac+E will be administered on an empty stomach at a dose of 205 mg/m2/day for 3 consecutive days per week for 3 weeks of a 4-week cycle, a dose and regimen being used in the ongoing oPac+E development program. Participants who experience toxicity may continue treatment with dose modifications (dose reduction, dose delay) as allowed during management of common paclitaxel toxicity, if considered appropriate by the investigator. oPac+E treatment will be discontinued in participants who did not recover within 3 weeks from oral paclitaxel toxicity that interrupted treatment. Participants in the Treatment Part will continue receiving cycles of treatment until they meet protocol-specified discontinuation criteria or the investigator is of the opinion that the participant is no longer benefitting from treatment and enter the safety follow-up. CT scans will be performed for surveillance of disease every 8 weeks. oPac+E treatment will be stopped if there is disease progression. During the safety follow-up, participants will be followed for 30 days after their last dose. A final visit will occur at the last clinic visit or up to 30 days after the last dose administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, balanced, multidose, 2-period, two-way (i.e., fed versus fasted), crossover design to examine the effect of food on paclitaxel bioavailability when administered as oPac+E to eligible participants. After completion of the two-way cross over periods, a subset of participants will receive concurrent encequidar and oral paclitaxel capsules after a low-fat meal in Period 3, which is a nonrandomized single arm. Following the Food Effect Part, continued treatment will be offered in the Treatment Part of the study for all participants who complete the Food Effect Part. In the Food Effect Part (two-way crossover), approximately 46 participants will be randomized. After participants have finished Period 2, they will be asked if they feel comfortable entering Period 3. Enrollment of participants into Period 3 will stop after 8 participants have been enrolled.
| Arm | Type | Receives |
|---|---|---|
| The Effect of Food on the Bioavailability of Oral Paclitaxel Administered with Encequidar | Experimental | Drug: Oral Paclitaxel in combination with Encequidar tabletThe Food Effect study (randomized 2-period, two-way crossover), participants will receive oPac+E in 2 sequences (fed/fasted or fasted/fed) in which encequidar is administered 1 hour before the oral paclitaxel capsules. A treatment of oPac+E consisting of 3 daily doses will be administered on 3 consecutive days in each period 1 and 2. In Period 3, participants will receive concurrent administration of encequidar and oral paclitaxel after a low-fat meal. |
| The Effect of Fasting on the Bioavailability of Oral Paclitaxel Administered with Encequidar | Experimental | Drug: Oral Paclitaxel in combination with Encequidar tabletThe Food Effect study (randomized 2-period, two-way crossover), participants will receive oPac+E in 2 sequences (fed/fasted or fasted/fed) in which encequidar is administered 1 hour before the oral paclitaxel capsules. A treatment of oPac+E consisting of 3 daily doses will be administered on 3 consecutive days in each period 1 and 2. In Period 3, participants will receive concurrent administration of encequidar and oral paclitaxel after a low-fat meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed written informed consent
- ≥18 years of age
- Cancer patients for whom treatment with paclitaxel monotherapy is a reasonable therapeutic option, including but not limited to: advanced or metastatic breast cancer, gastric cancer (who have not undergone gastric resection surgery), non-small cell lung cancer, or ovarian cancer.
- 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 and for which oral paclitaxel is a reasonable treatment. Participants who are intolerant of standard-of-care treatment or declined standard-of-care treatment may be enrolled.
- Adequate hematologic status as demonstrated by not requiring granulocyte colony stimulating factor (G-CSF) or transfusion support within 30 days prior to randomization to achieve the following at Screening/Baseline:
Key exclusion criteria (17 listed)
- Not recovered to grade ≤1 toxicity from previous anticancer treatments or previous investigational products (IPs); exception to this is alopecia or lymphopenia.
- Received IPs within 21 days or 5 half-lives of the first dosing day, whichever is shorter.
- 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.
- Taking a medication known to be a moderate or strong cytochrome P450 (CYP) 3A4 inhibitor or inducer or neurokinin-1 receptor antagonist (NK-1) inhibitor within 14 days prior to start of dosing.
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 |
|---|---|---|
| Oral Paclitaxel in combination with Encequidar tabletParticipant is either fasted or fed when taking Oral Paclitaxel in combination with Encequidar tablet | Drug | The Effect of Fasting on the Bioavailability of Oral Paclitaxel Administered with Encequidar, The Effect of Food on the Bioavailability of Oral Paclitaxel Administered with Encequidar |
Primary outcome
Area under the plasma concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-t) and AUC from time 0 to infinity (AUC0-INF) of oral paclitaxel when paclitaxel is administered one hour following encequidar.
Time frame: Plasma sample collected from pre-dose on Day 1 to Day 8.
The bioavailability of oral paclitaxel, measured by AUC0-t and AUC0-INF, will be determined after oral paclitaxel is administered one hour following encequidar dosing under both fed and fasting conditions. AUC0-t will be calculated using trapezoidal rule. AUC0-INF will be calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
2 secondary outcomes
Number of participants with treatment emergent adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame: From screening to the final follow-up visit.
Maximum observed concentration (Cmax) of oral paclitaxel when paclitaxel is administered one hour following encequidar.
Time frame: Plasma sample collected from pre-dose on Day 1 to Day 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral Paclitaxel in combination with Encequidar tablet in people with Metastatic Breast Cancer, run by Health Hope Pharma.
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 17 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: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Area under the plasma concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-t) and AUC from time 0 to infinity (AUC0-INF) of oral paclitaxel when paclitaxel is administered one hour following encequidar. (time frame: Plasma sample collected from pre-dose on Day 1 to Day 8.). 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 12 May 2026.