Oral Paclitaxel + Encequidar vs IV Paclitaxel in Treatment of HER2 Negative Metastatic Breast Cancer

NCT06835400 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: HHP-ORAX-300
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current study is being conducted to find an optimal Oral Paclitaxel + Encequidar dose and regimen based on prior experience with oral paclitaxel (stage 1) and to compare that dose to an accepted dose and regimen of intravenous (IV) paclitaxel in subjects with metastatic breast cancer (stage 2).

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Stage 1: Confirmed Tumor Response

  Confirmed tumor response based on BICR timepoint evaluations of CT scans using RECIST v1.1 criteria

  6 months

• Stage 2: Confirmed Tumor Response

  Confirmed tumor response based on BICR timepoint evaluations of CT scans using RECIST v1.1 criteria

  1 Year

Study Arms (4)

Stage 1: Oral Paclitaxel 165 mg/m2 + Encequidar

EXPERIMENTAL

A minimum of 20 subjects per group will be centrally randomized 1:1 to Oral Paclitaxel 165 mg/m2 + Encequidar 3 weeks of a 4-week cycle (3/4) or Oral Paclitaxel 205 mg/m2 (3/4) + Encequidar.

Drug: Paclitaxel Capsule; Drug: Encequidar tablet

Stage 1: Oral Paclitaxel 205 mg/m2 + Encequidar

EXPERIMENTAL

A minimum of 20 subjects per group will be centrally randomized 1:1 to Oral Paclitaxel 165 mg/m2 + Encequidar 3 weeks of a 4-week cycle (3/4) or Oral Paclitaxel 205 mg/m2 (3/4) + Encequidar.

Drug: Paclitaxel Capsule; Drug: Encequidar tablet

Stage 2: Oral Paclitaxel + Encequidar

EXPERIMENTAL

Drug: Paclitaxel Capsule; Drug: Encequidar tablet

Stage 2: IV Paclitaxel

ACTIVE COMPARATOR

Drug: IV Paclitaxel

Interventions

Paclitaxel Capsule DRUG

Paclitaxel Capsule

Stage 1: Oral Paclitaxel 165 mg/m2 + Encequidar; Stage 1: Oral Paclitaxel 205 mg/m2 + Encequidar; Stage 2: Oral Paclitaxel + Encequidar

IV Paclitaxel DRUG

IV Paclitaxel

Stage 2: IV Paclitaxel

Encequidar tablet DRUG

Encequidar tablet

Stage 1: Oral Paclitaxel 165 mg/m2 + Encequidar; Stage 1: Oral Paclitaxel 205 mg/m2 + Encequidar; Stage 2: Oral Paclitaxel + 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
• Histologically or cytologically confirmed HER2 negative breast cancer for whom IV paclitaxel monotherapy has been recommended.
• HER2 negative per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guideline. Subjects can be estrogen receptor/progesterone receptor (ER/PR) positive or negative per ASCO CAP guideline, but ER/PR and HER2 receptor status must be known.
• Metastatic breast cancer with target lesions measurable by CT scan per RECIST v1.1 criteria confirmed by BICR
• 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:
• Absolute neutrophil count (ANC) ≥1500/mm3
• Platelet count ≥100,000/mm3
• Hemoglobin ≥9 g/dL
• Adequate liver function as demonstrated by:
• Total bilirubin ≤upper limit of normal (ULN) unless the subject has Gilbert's disease, for which bilirubin must be ≤2.0 × ULN
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN
• Adequate renal function as demonstrated by estimated glomerular filtration rate (eGFR) ≥60 mL/min
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy at least 6 months, in the judgment of the Investigator

You may not qualify if:

• Not recovered to ≤grade 1 toxicity from previous anticancer treatments or previous investigational product (IP) except alopecia
• QTcF interval ≥470 msec at baseline
• Relapsed less than 6 months following treatment with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease
• Known active central nervous system metastasis, including leptomeningeal involvement
• Currently receiving other medications intended for the treatment of their malignancy
• Received other IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
• Received biologics or monoclonal antibodies intended for the treatment of their malignancy within 30 days of the first study dosing day
• Received radiation therapy within 2 weeks prior to signing informed consent or radiation therapy is planned within 6 months from the time of signing informed consent
• 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 in the study
• Taking a medication known to be a moderate or strong CYP2C8 inhibitor or inducer within 14 days prior to start of dosing in the study
• 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 in the study
• 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
• 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 GI tract, inability to take oral medication, or have a history of GI disease or other medical condition that, in the opinion of the Investigator may interfere with oral drug absorption

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HHP-ORAX-300 is a Phase 3, open-label, randomized, two-stage dose optimization and noninferiority study. The study includes 2 stages: Stage 1 is a dose-optimization design that will select an Oral Paclitaxel + Encequidar regimen to test against IV paclitaxel 80 mg/m2 in a confirmatory Stage 2.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: July 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share