A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients

NCT03165955 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: KX-ORAX-007U1111-1176-4228
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 6

Brief Summary

This is a multicenter, open-label, single-arm PK study in patients for whom paclitaxel treatment is indicated.

Conditions

Breastcancer

Keywords

breast cancer; paclitaxel

Outcome Measures

Primary Outcomes (10)

• PK Parameters for paclitaxel_AUC (0-52)

  PK parameters were summarized using the mean, SD

  PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

• PK Parameters for paclitaxel_Cmax

  PK parameters were summarized using the mean, SD

  PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

• PK Parameters for paclitaxel_Ctrough(24)

  PK parameters were summarized using the mean, SD

  PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

• PK Parameters for paclitaxel_Ctrough(48)

  PK parameters were summarized using the mean, SD

  PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

• PK Parameters for paclitaxel_Cmax(0-24)

  PK parameters were summarized using the mean, SD

  PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

• PK Parameters for paclitaxel_Cmax(24-48)

  PK parameters were summarized using the mean, SD

  PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

• PK Parameters for paclitaxel_Cmax(48-52)

  PK parameters were summarized using the mean, SD

  PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

• PK Parameters for paclitaxel_tmax(0-24)

  PK parameters were summarized using the median, minimum, maximum

  PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

• PK Parameters for paclitaxel_tmax(24-48)

  PK parameters were summarized using the median, minimum, maximum

  PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

• PK Parameters for paclitaxel_tmax(48-52)

  PK parameters were summarized using the median, minimum, maximum

  PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Secondary Outcomes (4)

• Safety of Oraxol in Breast Cancer Patients

  From enrollment through study completion, approximately 17 weeks

• Response Rate

  From baseline through study completion, around 21 weeks

• Progression-free Survival

  From baseline through study completion, around 21 weeks

• Overall Survival

  From baseline through study completion, around 21 weeks

Study Arms (1)

Oraxol

EXPERIMENTAL

Subjects will receive Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.

Drug: Oraxol

Interventions

Oraxol DRUG

HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules

Also known as: HM30181 methanesulfonate monohydrate, Oral paclitaxel capsules

Oraxol

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent
• Women ≥18 years of age on day of consent
• Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
• Measurable disease as per RECIST v1.1 criteria
• Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) maintain:
• Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
• Platelet count ≥100 x 10\^9/L
• Hemoglobin (Hgb) ≥9 g/dL
• Adequate liver function
• Total bilirubin of ≤1.5 mg/dL
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) or ≤5 x ULN if liver metastasis is present
• Alkaline phosphatase (ALP) ≤3 x ULN or ≤5 x ULN if bone metastasis is present
• Gamma glutamyl transferase (GGT) \<10 x ULN
• Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if:

• Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
• If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment
• Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
• Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
• Known CNS metastasis, including leptomeningeal involvement
• Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
• Are currently receiving other medications intended for the treatment of their malignancy
• Women who are pregnant or breastfeeding
• Taking prohibited medications:
• Use of warfarin. Subjects 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 in the study provided they are switched to low molecular weight heparin at least 7 days prior to 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
• Known allergic reaction or intolerance to study medication components
• Known allergic reaction or intolerance to contrast media
• Subjects who, in the Investigator's opinion, are not suitable for participation in this study

Sponsors & Collaborators

• Health Hope Pharma: lead
• PharmaEssentia: collaborator

Study Sites (6)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Taipei Veterans Generla Hospital

Taipei, 11217, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Shuang Ho Hospital

Taipei, 23561, Taiwan

Location

Related Publications (1)

• Dai MS, Chao TC, Chiu CF, Lu YS, Shiah HS, Jackson CGCA, Hung N, Zhi J, Cutler DL, Kwan R, Kramer D, Chan WK, Qin A, Tseng KC, Hung CT, Chao TY. Oral paclitaxel and encequidar in patients with breast cancer: a pharmacokinetic, safety, and antitumor activity study. Ther Adv Med Oncol. 2023 Jul 21;15:17588359231183680. doi: 10.1177/17588359231183680. eCollection 2023.

  PMID: 37492633 DERIVED

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

Results Point of Contact

• Title: Regional Project Manager
• Organization: Athenex Inc.

lmeiying@athenex.com

+886-978365735

Study Officials

• Tsu-Yi Chao, MD, DMS, PhD

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 24, 2017
• Study Start: May 9, 2017
• Primary Completion: November 22, 2018
• Study Completion: November 22, 2018
• Last Updated: March 12, 2025
• Results First Posted: July 8, 2020

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)