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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03165955
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
PharmaEssentia
Information provided by (Responsible Party):
Athenex, Inc. ( Kinex Pharmaceuticals Inc )

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

Condition or disease Intervention/treatment Phase
Breastcancer Drug: Oraxol Phase 1

Detailed Description:
This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer patients for whom paclitaxel treatment is indicated. The study contains 3 periods: the Screening / Baseline Period, the Treatment Period, and the Follow-up Period. A Final Visit will occur within 7 days of the last dose of study treatment. If subjects achieve stable disease (SD), partial response (PR), or complete response (CR) at the end of the Treatment Period, they may continue Oraxol treatment in a separate extension study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Oraxol
Subjects will receive Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Drug: Oraxol
HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules
Other Names:
  • HM30181 methanesulfonate monohydrate
  • Oral paclitaxel capsules




Primary Outcome Measures :
  1. Evaluation of PK parameters for oral paclitaxel - Cmax [ Time Frame: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose ]

    Plasma concentrations for paclitaxel only will be analyzed to determine the maximum observed concentration (Cmax).

    Pharmacokinetic parameters will be summarized using the mean, standard deviation, median, minimum, and maximum. Summaries of PK parameters will also include the geometric mean and the coefficient of variation. Summary PK and individual timepoints will be tabulated and displayed graphically and listed for all subjects.


  2. Evaluation of PK parameters for oral paclitaxel - Cmin [ Time Frame: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose ]

    Plasma concentrations for paclitaxel only will be analyzed to determine the minimum observed concentration (Cmin).

    Pharmacokinetic parameters will be summarized using the mean, standard deviation, median, minimum, and maximum. Summaries of PK parameters will also include the geometric mean and the coefficient of variation. Summary PK and individual timepoints will be tabulated and displayed graphically and listed for all subjects.


  3. Evaluation of PK parameters for oral paclitaxel - Cavg [ Time Frame: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose ]

    Plasma concentrations for paclitaxel only will be analyzed to determine the average observed concentration (Cavg).

    Pharmacokinetic parameters will be summarized using the mean, standard deviation, median, minimum, and maximum. Summaries of PK parameters will also include the geometric mean and the coefficient of variation. Summary PK and individual timepoints will be tabulated and displayed graphically and listed for all subjects.


  4. Evaluation of PK parameters for oral paclitaxel - AUC0-t [ Time Frame: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose ]

    Plasma concentrations for paclitaxel only will be analyzed to determine the area under the curve extrapolated to infinity (AUC0-t).

    Pharmacokinetic parameters will be summarized using the mean, standard deviation, median, minimum, and maximum. Summaries of PK parameters will also include the geometric mean and the coefficient of variation. Summary PK and individual timepoints will be tabulated and displayed graphically and listed for all subjects.


  5. Evaluation of PK parameters for oral paclitaxel - AUC [ Time Frame: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose ]

    Plasma concentrations for paclitaxel only will be analyzed to determine the area under the curve (AUC).

    Pharmacokinetic parameters will be summarized using the mean, standard deviation, median, minimum, and maximum. Summaries of PK parameters will also include the geometric mean and the coefficient of variation. Summary PK and individual timepoints will be tabulated and displayed graphically and listed for all subjects.



Secondary Outcome Measures :
  1. Safety assessments of adverse event (AE) and serious adverse event (SAE) information of Oraxol [ Time Frame: through study completion, approximately 8 months ]
    Safety assessments will consist of determining and recording all AEs (including for both increasing and decreasing severity) and SAEs

  2. Laboratory evaluation for hematology, blood chemistry and urine analysis [ Time Frame: through study completion, approximately 8 months ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  3. Response rate [ Time Frame: From date of study start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months ]
    Tumor response rate and its 95% confidence interval (CI) will be evaluated based on the number of subjects with any post baseline CR or PR per RECIST evaluations. In addition, the incidence of tumor response at each clinical visit will be summarized.

  4. Periodic measurement of vital signs - pulse rate [ Time Frame: Screening/Baseline, prior to dosing Day 1 of Weeks 1, 2, 3, 4, 8, 12, and 16, and at the Final Visit ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  5. Periodic measurement of vital signs - systolic and diastolic blood pressure [ Time Frame: Screening/Baseline, prior to dosing Day 1 of Weeks 1, 2, 3, 4, 8, 12, and 16, and at the Final Visit ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  6. Periodic measurement of vital signs - respiratory rate [ Time Frame: Screening/Baseline, prior to dosing Day 1 of Weeks 1, 2, 3, 4, 8, 12, and 16, and at the Final Visit ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  7. Periodic measurement of vital signs - body temperature [ Time Frame: Screening/Baseline, prior to dosing Day 1 of Weeks 1, 2, 3, 4, 8, 12, and 16, and at the Final Visit ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  8. Periodic measurement of physical examinations - weight [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  9. Periodic measurement of physical examinations - an assessment of head [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  10. Periodic measurement of physical examinations - an assessment of eyes [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  11. Periodic measurement of physical examinations - an assessment of ears [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  12. Periodic measurement of physical examinations - an assessment of nose [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  13. Periodic measurement of physical examinations - an assessment of throat [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  14. Periodic measurement of physical examinations - an assessment of gastrointestinal (GI) [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  15. Periodic measurement of physical examinations - an assessment of cardiovascular [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  16. Periodic measurement of physical examinations - an assessment of respiratory [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  17. Periodic measurement of physical examinations - an assessment of integumentary [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  18. Periodic measurement of physical examinations - an assessment of muscular-skeleton [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  19. Periodic measurement of physical examinations - an assessment of neurological systems [ Time Frame: Screening/Baseline and every 8 weeks, (Weeks 8 and 16). ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  20. Periodic measurement of physical examinations - an assessment of height [ Time Frame: Screening/Baseline ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  21. Periodic measurement of ECGs - rate [ Time Frame: Screening/Baseline and on Day 1 at Weeks 4, 8, 12, and 16 ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  22. Periodic measurement of ECGs - rhythm [ Time Frame: Screening/Baseline and on Day 1 at Weeks 4, 8, 12, and 16 ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  23. Periodic measurement of ECGs - intervals [ Time Frame: Screening/Baseline and on Day 1 at Weeks 4, 8, 12, and 16 ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.

  24. Periodic measurement of ECGs - QTc/QTcF [ Time Frame: Screening/Baseline and on Day 1 at Weeks 4, 8, 12, and 16 ]
    For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA; version 16.0 or higher). The CTCAE criteria v4.03 will be used to grade severity of the AEs. Subject incidence of AEs will be displayed by SOC. The incidence of AEs will be summarized. Adverse events will also be summarized by severity and relationship to study drug. Subject incidence of SAEs will be displayed.



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
Criteria

Inclusion Criteria:

  1. Signed written informed consent
  2. Women ≥18 years of age on day of consent
  3. Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
  4. Measurable disease as per RECIST v1.1 criteria
  5. Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF)
  6. Adequate liver function
  7. Adequate renal function
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  9. Life expectancy of at least 3 months
  10. Willing to fast for 8 hours before and 4 hours after Oraxol administration on all treatment days
  11. Willing to abstain from alcohol consumption for 3 days before the first dose of study drug through the completion of the second inpatient PK sampling period
  12. Willing to refrain from caffeine consumption for 12 hours before each inpatient dosing period through the completion of protocol-specified PK sampling for that week
  13. Subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of assigned study treatment.
  14. Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 72 hours before dosing.

Exclusion Criteria:

  1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
  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. Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
  4. Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
  5. Known CNS metastasis, including leptomeningeal involvement
  6. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
  7. Are currently receiving other medications intended for the treatment of their malignancy
  8. Women who are pregnant or breastfeeding
  9. Taking prohibited medications:
  10. 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.
  11. 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
  12. Known allergic reaction or intolerance to study medication components
  13. Known allergic reaction or intolerance to contrast media
  14. Subjects who, in the Investigator's opinion, are not suitable for participation in this study

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 ClinicalTrials.gov identifier (NCT number): NCT03165955


Contacts
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Contact: Serena Lin +886-277039399 ext 10201 lmeiying@athenex.com

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Chang-Fang Chiu, MD.PHD    +886-4-2205-3366 ext 3483    d5686@mail.cmuh.org.tw   
Principal Investigator: Chang-Fang Chiu, MD.PHD         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10048
Contact: Yen-Shen Lu, MD.PHD    +886-2-2312-3456 ext 251673    yslu@ntu.edu.tw   
Taipei Medical University Hospital Recruiting
Taipei, Taiwan, 110
Contact: Shih-Hsin Tu, MD       drtu2466@tmu.edu.tw   
Principal Investigator: Shih-Hsin Tu, MD         
Taipei Veterans Generla Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Ta-Chung Chao, MD.    +886-2-2871-2121    tcchao@vghtpe.gov.tw   
Principal Investigator: Ta-Chung Chao, MD         
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
Contact: Ming-Shen Dai, MD    +886-2-8792-3311 ext 12623    dms1201@gmail.com   
Principal Investigator: Ming-Shen Dai, MD         
Shuang Ho Hospital Recruiting
Taipei, Taiwan, 23561
Contact: Tsu-Yi Chao, MD, DMS, PhD    886227361661 ext 3229    10575@s.tmu.edu.tw   
Principal Investigator: Tsu-Yi Chao, MD, DMS, PhD         
Sponsors and Collaborators
Kinex Pharmaceuticals Inc
PharmaEssentia
Investigators
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Principal Investigator: Tsu-Yi Chao, MD, DMS, PhD Taipei Medical University Shuang Ho Hospital

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Responsible Party: Kinex Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT03165955     History of Changes
Other Study ID Numbers: KX-ORAX-007
U1111-1176-4228 ( Other Identifier: ICTRP )
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Athenex, Inc. ( Kinex Pharmaceuticals Inc ):
breast cancer
paclitaxel

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action