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

August 2, 2022 updated by: Athenex, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
402

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • COIBA
      • Ciudad Autónoma de Buenos Aires, Argentina
        • CEMEDIC
      • Ciudad Autónoma de Buenos Aires, Argentina
        • Fundación Investigar
      • La Rioja, Argentina
        • Fundación Centro Oncológico Riojano Integral (CORI)
      • Santa Fe, Argentina
        • Hospital Provincial del Centenario
      • Santa Fe, Argentina
        • Instituto de Oncologia de Rosario
      • Santa Fe, Argentina
        • Sanatorio Britanico
      • Tucuman, Argentina
        • Centro Medico San Roque
      • Tucumán, Argentina
        • CAIPO
    • Buenos Aires
      • Pergamino, Buenos Aires, Argentina
        • Centro de Investigacion Pergamino SA
    • Cordoba
      • Ciudad de Córdoba, Cordoba, Argentina
        • IONC
      • Córdoba, Cordoba, Argentina
        • Clinica Universitaria Privada Reina Fabiola
    • La Pampa
      • Santa Rosa, La Pampa, Argentina
        • Centro Oncologico Infinito
      • Santa Rosa, La Pampa, Argentina
        • Fundacion Koriza
    • Rio Negro
      • Viedma, Rio Negro, Argentina
        • Clinica Viedma
  • Chile
      • Santiago de Chile, Chile
        • Fundacion Arturo Lopez Perez
      • Santiago de Chile, Chile
        • Hospital de Referencia de Salud Cordillera Unidad de Patología Mamaria
      • Santiago de Chile, Chile
        • Hospital San Borja Arriarán
      • Santiago de Chile, Chile
        • IRAM
      • Temuco, Chile
        • Clinica Alemana Temuco
  • Colombia
      • Bogota, Colombia
        • Instituto Nacional de Cancerologia E.S.E.
      • Medellín, Colombia
        • Fundacion Colombiana de Cancerologia Clinica Vida
      • Medellín, Colombia
        • Fundación Hospitalaria San Vicente de Paul
      • Valle, Colombia
        • Hemato Oncologos S.A.
  • Dominican Republic
      • Santiago de los Caballeros, Dominican Republic
        • Hospital Metropolitano de Santiago (HOMS)
      • Santo Domingo, Dominican Republic
        • Clinical research
      • Santo Domingo, Dominican Republic
        • Hospital General de la Plaza de la Salud
  • Ecuador
      • Guayaquil, Ecuador
        • Hospital SOLCA
      • Quito, Ecuador
        • Hospital Carlos Andrade Martín
      • Quito, Ecuador
        • Hospital SOLCA
  • El Salvador
      • San Salvador, El Salvador
        • Espemedic
      • San Salvador, El Salvador
        • Hospital Diagnotico Clinica Oncologica & Cancer Research
  • Guatemala
      • Guatemala City, Guatemala
        • American Cancer Center
      • Guatemala City, Guatemala
        • CELAN Clínica Médica
      • Guatemala City, Guatemala
        • Clinica privada
      • Guatemala City, Guatemala
        • Grupo Angeles, S.A.
      • Guatemala City, Guatemala
        • Oncomedica en Guatemala
      • Guatemala city, Guatemala
        • Clinica privada
      • Quetzaltenango, Guatemala
        • CRESEM
  • Honduras
      • Cortés, Honduras
        • Excel Medica
      • Cortés, Honduras
        • Tecnología en Investigación
  • Panama
      • Panama city, Panama
        • Centro Hemato Oncologico Panama
  • Peru
      • Lima, Peru
        • Clínica Oncológica Miraflores
      • Lima, Peru
        • Hospital Cayetano Heredia
      • Lima, Peru
        • Hospital Nacional del Arzobispo Loayza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
19 to 22 weeks
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
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).]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Athenex, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Cutler, MD, Kinex Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KX-ORAX-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings