A Study to Investigate the Effect of Food on the Bioavailability of Oral Paclitaxel Administered With Encequidar in Participants With Advanced Solid Tumors

NCT07580833 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HHP-ORAX-100
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  From screening to the final follow-up visit.

• Maximum observed concentration (Cmax) of oral paclitaxel when paclitaxel is administered one hour following encequidar.

  Plasma sample collected from pre-dose on Day 1 to Day 8.

Other Outcomes (1)

• AUC0-t and AUC0-INF for oral paclitaxel when administered concomitantly with encequidar

  Plasma sample collected from predose on Day 1 to Day 8.

Study Arms (2)

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.

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.

Drug: Oral Paclitaxel in combination with Encequidar tablet

Interventions

Oral Paclitaxel in combination with Encequidar tablet DRUG

Participant is either fasted or fed when taking Oral Paclitaxel in combination with Encequidar tablet

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

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Health Hope Pharma: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

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, 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.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share