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Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02594371
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : August 3, 2022
Information provided by (Responsible Party):
Athenex, Inc.

Brief Summary:
To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic breast cancer

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Oraxol Drug: IV paclitaxel Phase 3

Detailed Description:
This is a Phase 3, open-label, randomized, multicenter study in approximately 360 adult female subjects with histologically- or cytologically-confirmed breast cancer that is metastatic for whom treatment with IV paclitaxel monotherapy has been recommended by their oncologist. Approximately 400 subjects will be enrolled to provide 360 evaluable subjects. The subjects must have measurable metastatic target lesion disease as per RECIST v1.1 criteria. Subjects will be randomized in a 2:1 ratio to either Oraxol or IV paclitaxel (as Taxol or generic).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Multicenter, Phase 3 Study to Determine the Safety, Tolerability, and Tumor Response of Oraxol and Its Comparability to IV Taxol or Generic IV Paclitaxel in Subjects With Metastatic Breast Cancer
Actual Study Start Date : December 2, 2015
Actual Primary Completion Date : July 25, 2019
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Oraxol (paclitaxel + HM30181AK-US)

Oraxol paclitaxel - supplied as 30-mg capsules

Oraxol HM30181 methansulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets

Drug: Oraxol
Other Names:
  • HM30181 methanesulfonate monohydrate
  • Oral paclitaxel capsules

Active Comparator: IV paclitaxel
IV paclitaxel - supplied as Taxol or generic
Drug: IV paclitaxel

Primary Outcome Measures :
  1. Tumor response as determined by response criteria [ Time Frame: 19 to 22 weeks ]
    Tumor response is evaluated using the response evaluation criteria in solid tumors (RECIST v1.1 criteria).

  2. Safety and tolerability assessments of Oraxol compared with IV paclitaxel, as determined by laboratory, adverse event (AE) and serious adverse event (SAE) information [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to ~48 months (expected end of study).] ]
    Safety assessments will consist of determining and recording all AEs and SAEs; laboratory evaluation of hematology, blood chemistry, and urine analyses; periodic measurement of vital signs and electrocardiograms (ECGs); and the performance of physical examinations, as detailed in the schedule of procedures and assessments of the protocol

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to ~48 months (expected end of study). ]
    The endpoint of progression-free survival is defined as not having died or progression of disease. Lost to follow-up will be considered as censored.

  2. Overall survival (OS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to ~48 months (expected end of study). ]
    The endpoint of overall survival is defined as death, confirmed alive, and lost to follow-up. Alive and lost to follow-up will be considered as censored.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signed written informed consent
  2. Women ≥18 years of age
  3. Histologically- or cytologically-confirmed breast cancer for whom IV paclitaxel (as Taxol or generic) monotherapy has been recommended by their oncologist
  4. Measurable metastatic target lesion disease measurable by CT scan as per RECIST v1.1 criteria
  5. Adequate hematological status as demonstrated by not requiring granulocyte-colony stimulating factor (G-CSF) or transfusion support to achieve the following at Screening:

    • Absolute neutrophil count (ANC) ≥1.5 x 109/L
    • Platelet count ≥100 x 109/L
    • Hemoglobin ≥10 g/dL
  6. Adequate liver function as demonstrated by:

    • Total bilirubin within normal limits (WNL)
    • Alanine aminotransferase and aspartate aminotransferase ≤3 x upper limit of normal (ULN)
    • Alkaline phosphatase ≤3 x ULN or ≤5 x ULN if bone metastasis is present
    • Gamma glutamyl transferase (GGT) ≤5 x ULN
  7. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  9. Life expectancy of at least 6 months, in the judgement of the investigator
  10. Subjects must be postmenopausal (≥12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception and agree to used of contraception for 30 days after their last dose of assigned study treatment.
  11. Subjects who are of childbearing potential must have a negative screening serum pregnancy test.

Exclusion Criteria:

  1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products
  2. 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
  3. Only evidence of metastatic disease is to bone or other nontarget or nonmeasurable lesions (including, for example, ascites or plural effusion) according to RECIST v1.1 criteria
  4. Central nervous system metastasis, including leptomeningeal involvement
  5. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
  6. Are currently receiving other medications intended for the treatment of their malignancy
  7. Received radiation therapy within 2 weeks prior to signing informed consent and those for whom radiation therapy is planned within 6 months from the time of signing informed consent
  8. Women who are pregnant or breastfeeding
  9. Taking a medication known to be a strong P-gp inhibitor or inducer within 14 days of starting treatment
  10. Taking an oral medication with a narrow therapeutic index known to be a P-gp substrate within 24 hours prior to start of treatment
  11. Taking a medication known to be a strong cytochrome P450 (CYP) 3A4 inhibitor (eg, ketoconazole) or inducer (eg, rifampin or St. John's Wort) within 14 days of starting treatment
  12. Taking a medication known to be a strong inhibitor (eg, gemfibrozil) or inducer (eg, rifampin) of CYP2C8 within 14 days of starting treatment
  13. 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
  14. Major surgery to the upper GI tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator may interfere with oral drug absorption
  15. History of significant hypersensitivity-type reactions to paclitaxel or Cremophor EL (polyoxyl 35 castor oil, NF) that would contraindicate the use of IV paclitaxel formulated with Cremophor EL
  16. Known allergic reaction or intolerance to contrast media
  17. Documented history of true systemic allergic reaction to 3 or more medications
  18. For whom the Investigator believes that participation in this study would not be acceptable
  19. Known chronic hepatitis or cirrhosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02594371

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Sponsors and Collaborators
Athenex, Inc.
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Study Director: David Cutler, MD Kinex Pharmaceuticals Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Athenex, Inc. Identifier: NCT02594371    
Other Study ID Numbers: KX-ORAX-001
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action