Metastatic Breast CancerPhase 3NCT02594371
Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer
A Phase 3 study testing Oraxol and IV paclitaxel in people with Metastatic Breast Cancer, run by Athenex, Inc. at 45 sites in 10 countries.
Trial summary
To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Oraxol and IV paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 45 sitesin 10 countries
- Study dates
- 2 Dec 2015to 30 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Women ≥18 years of age
- Histologically- or cytologically-confirmed breast cancer for whom IV paclitaxel (as Taxol or generic) monotherapy has been recommended by their oncologist
- Measurable metastatic target lesion disease measurable by CT scan as per RECIST v1.1 criteria
- 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
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- Platelet count ≥100 x 109/L
- Hemoglobin ≥10 g/dL
- 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
- Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 6 months, in the judgement of the investigator
- 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.
- Subjects who are of childbearing potential must have a negative screening serum pregnancy test.
Who cannot join
- Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products
- 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
- 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
- Central nervous system 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
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- 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
- Women who are pregnant or breastfeeding
- Taking a medication known to be a strong P-gp inhibitor or inducer within 14 days of starting treatment
- Taking an oral medication with a narrow therapeutic index known to be a P-gp substrate within 24 hours prior to start of treatment
- 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
- Taking a medication known to be a strong inhibitor (eg, gemfibrozil) or inducer (eg, rifampin) of CYP2C8 within 14 days of starting 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
- 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
- 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
- Known allergic reaction or intolerance to contrast media
- Documented history of true systemic allergic reaction to 3 or more medications
- For whom the Investigator believes that participation in this study would not be acceptable
- Known chronic hepatitis or cirrhosis
Trial locations and contacts
45 sites in 10 countries.
45 sites in 10 countries
Argentina15 sites
CEMEDIC
Buenos Aires
COIBA
Buenos Aires
Fundación Investigar
Buenos Aires
Clinica Universitaria Privada Reina Fabiola
Córdoba, Córdoba Province
IONC
Córdoba, Córdoba Province
Fundación Centro Oncológico Riojano Integral (CORI)
La Rioja
Centro de Investigacion Pergamino SA
Pergamino, Buenos Aires
CAIPO
San Miguel de Tucumán
Centro Medico San Roque
San Miguel de Tucumán
Hospital Provincial del Centenario
Santa Fe
Instituto de Oncologia de Rosario
Santa Fe
Sanatorio Britanico
Santa Fe
Centro Oncologico Infinito
Santa Rosa, La Pampa Province
Fundación Koriza
Santa Rosa, La Pampa Province
Clinica Viedma
Viedma, Río Negro Province
Guatemala7 sites
American Cancer Center
Guatemala City
CELAN Clínica Médica
Guatemala City
Clinica Privada
Guatemala City
Clínica Privada
Guatemala City
Grupo Angeles, S.A.
Guatemala City
Oncomedica en Guatemala
Guatemala City
CRESEM
Quetzaltenango
Chile5 sites
Fundación Arturo López Pérez
Santiago
Hospital de Referencia de Salud Cordillera Unidad de Patología Mamaria
Santiago
Hospital San Borja Arriarán
Santiago
IRAM
Santiago
Clínica Alemana Temuco
Temuco
Colombia4 sites
Instituto Nacional de Cancerología E.S.E.
Bogotá
Fundación Colombiana de Cancerología Clinica Vida
Medellín
Fundación Hospitalaria San Vicente de Paúl
Medellín
Hemato Oncologos S.A.
Valle
Dominican Republic3 sites
Hospital Metropolitano de Santiago (HOMS)
Santiago de los Caballeros
Clinical Research
Santo Domingo
Hospital General de la Plaza de la Salud
Santo Domingo
Ecuador3 sites
Hospital SOLCA
Guayaquil
Hospital Carlos Andrade Martín
Quito
Hospital SOLCA
Quito
Peru3 sites
Clínica Oncológica Miraflores
Lima
Hospital Cayetano Heredia
Lima
Hospital Nacional del Arzobispo Loayza
Lima
El Salvador2 sites
Espemedic
San Salvador
Hospital Diagnotico Clinica Oncologica & Cancer Research
San Salvador
About this study
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
To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic breast cancer
Read the 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).
- Conditions
- Metastatic Breast Cancer
- Being tested
- Oraxol, IV paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraxolDrug
Also called HM30181 methanesulfonate monohydrate, Oral paclitaxel capsules
IV paclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Oraxol (paclitaxel + HM30181AK-US) | Experimental | Oraxol paclitaxel - supplied as 30-mg capsules
Oraxol HM30181 methansulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets Receives: Drug: Oraxol |
| IV paclitaxel | Active comparator | IV paclitaxel - supplied as Taxol or generic Receives: Drug: IV paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response as determined by response criteria
Tumor response is evaluated using the response evaluation criteria in solid tumors (RECIST v1.1 criteria).
Measured: 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
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
Measured: 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 outcomes (2)
Progression-free survival (PFS)
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.
Measured: 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)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start2 Dec 2015
- Primary completion25 Jul 2019
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Cutler, MD, Study director, Kinex Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594371
- Sponsor's protocol ID
- KX-ORAX-001
- Status last verified
- Aug 2022
- First submitted
- 28 Oct 2015
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Rugo HS, Umanzor GA, Barrios FJ, Vasallo RH, Chivalan MA, Bejarano S, Ramirez JR, Fein L, Kowalyszyn RD, Kramer ED, Wang H, Kwan MR, Cutler DL; Oraxol Study Consortium Investigators. Open-Label, Randomized, Multicenter, Phase III Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients With Metastatic Breast Cancer. J Clin Oncol. 2023 Jan 1;41(1):65-74. doi: 10.1200/JCO.21.02953. Epub 2022 Jul 20.
PubMed 35858154
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02594371
- Acronym / sponsor ID
- KX-ORAX-001
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic breast cancer
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oraxol (paclitaxel + HM30181AK-US) | Experimental | Drug: OraxolOraxol paclitaxel - supplied as 30-mg capsules Oraxol HM30181 methansulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets |
| IV paclitaxel | Active comparator | Drug: IV paclitaxelIV paclitaxel - supplied as Taxol or generic |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed written informed consent
- Women ≥18 years of age
- Histologically- or cytologically-confirmed breast cancer for whom IV paclitaxel (as Taxol or generic) monotherapy has been recommended by their oncologist
- Measurable metastatic target lesion disease measurable by CT scan as per RECIST v1.1 criteria
- Adequate hematological status as demonstrated by not requiring granulocyte-colony stimulating factor (G-CSF) or transfusion support to achieve the following at Screening:
Key exclusion criteria (19 listed)
- Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products
- 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
- 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
- Central nervous system metastasis, including leptomeningeal involvement
- Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OraxolAlso: HM30181 methanesulfonate monohydrate, Oral paclitaxel capsules | Drug | Oraxol (paclitaxel + HM30181AK-US) |
| IV paclitaxel | Drug | IV paclitaxel |
Primary outcome
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).
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
2 secondary outcomes
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 35858154Rugo HS, Umanzor GA, Barrios FJ, Vasallo RH, Chivalan MA, Bejarano S, Ramirez JR, Fein L, Kowalyszyn RD, Kramer ED, Wang H, Kwan MR, Cutler DL; Oraxol Study Consortium Investigators. Open-Label, Randomized, Multicenter, Phase III Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients With Metastatic Breast Cancer. J Clin Oncol. 2023 Jan 1;41(1):65-74. doi: 10.1200/JCO.21.02953. Epub 2022 Jul 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cutler, MD study director
Kinex Pharmaceuticals Inc.
45 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oraxol and IV paclitaxel in people with Metastatic Breast Cancer, run by Athenex, Inc. at 45 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Argentina, Guatemala, Chile, Colombia, Dominican Republic and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response as determined by response criteria (time frame: 19 to 22 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.