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

NCT02594371 | Completed Phase 3 DMC

• 1 other identifier: KX-ORAX-001
• Study Type: interventional
• Target: 402
• Locations: 10 countries
• Sites: 45

Brief Summary

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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Tumor response as determined by response criteria

  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

  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 Outcomes (2)

• Progression-free survival (PFS)

  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)

  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).

Study Arms (2)

Oraxol (paclitaxel + HM30181AK-US)

EXPERIMENTAL

Oraxol paclitaxel - supplied as 30-mg capsules Oraxol HM30181 methansulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets

Drug: Oraxol

IV paclitaxel

ACTIVE COMPARATOR

IV paclitaxel - supplied as Taxol or generic

Drug: IV paclitaxel

Interventions

Oraxol DRUG

Also known as: HM30181 methanesulfonate monohydrate, Oral paclitaxel capsules

Oraxol (paclitaxel + HM30181AK-US)

IV paclitaxel DRUG

IV paclitaxel

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
• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Athenex, Inc.: lead

Study Sites (45)

Centro de Investigacion Pergamino SA

Pergamino, Buenos Aires, Argentina

Location

Clinica Universitaria Privada Reina Fabiola

Córdoba, Córdoba Province, Argentina

Location

IONC

Córdoba, Córdoba Province, Argentina

Location

Centro Oncologico Infinito

Santa Rosa, La Pampa Province, Argentina

Location

Fundación Koriza

Santa Rosa, La Pampa Province, Argentina

Location

Clinica Viedma

Viedma, Río Negro Province, Argentina

Location

CEMEDIC

Buenos Aires, Argentina

Location

COIBA

Buenos Aires, Argentina

Location

Fundación Investigar

Buenos Aires, Argentina

Location

Fundación Centro Oncológico Riojano Integral (CORI)

La Rioja, Argentina

Location

CAIPO

San Miguel de Tucumán, Argentina

Location

Centro Medico San Roque

San Miguel de Tucumán, Argentina

Location

Hospital Provincial del Centenario

Santa Fe, Argentina

Location

Instituto de Oncologia de Rosario

Santa Fe, Argentina

Location

Sanatorio Britanico

Santa Fe, Argentina

Location

Fundación Arturo López Pérez

Santiago, Chile

Location

Hospital de Referencia de Salud Cordillera Unidad de Patología Mamaria

Santiago, Chile

Location

Hospital San Borja Arriarán

Santiago, Chile

Location

IRAM

Santiago, Chile

Location

Clínica Alemana Temuco

Temuco, Chile

Location

Instituto Nacional de Cancerología E.S.E.

Bogotá, Colombia

Location

Fundación Colombiana de Cancerología Clinica Vida

Medellín, Colombia

Location

Fundación Hospitalaria San Vicente de Paúl

Medellín, Colombia

Location

Hemato Oncologos S.A.

Valle, Colombia

Location

Hospital Metropolitano de Santiago (HOMS)

Santiago de los Caballeros, Dominican Republic

Location

Clinical Research

Santo Domingo, Dominican Republic

Location

Hospital General de la Plaza de la Salud

Santo Domingo, Dominican Republic

Location

Hospital SOLCA

Guayaquil, Ecuador

Location

Hospital Carlos Andrade Martín

Quito, Ecuador

Location

Hospital SOLCA

Quito, Ecuador

Location

Espemedic

San Salvador, El Salvador

Location

Hospital Diagnotico Clinica Oncologica & Cancer Research

San Salvador, El Salvador

Location

American Cancer Center

Guatemala City, Guatemala

Location

CELAN Clínica Médica

Guatemala City, Guatemala

Location

Clinica Privada

Guatemala City, Guatemala

Location

Clínica Privada

Guatemala City, Guatemala

Location

Grupo Angeles, S.A.

Guatemala City, Guatemala

Location

Oncomedica en Guatemala

Guatemala City, Guatemala

Location

CRESEM

Quetzaltenango, Guatemala

Location

Excel Medica

Cortés, Honduras

Location

Tecnología en Investigación

Cortés, Honduras

Location

Centro Hemato Oncológico Panamá

Panama City, Panama

Location

Clínica Oncológica Miraflores

Lima, Peru

Location

Hospital Cayetano Heredia

Lima, Peru

Location

Hospital Nacional del Arzobispo Loayza

Lima, Peru

Location

Related Publications (1)

• 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.

  PMID: 35858154 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

Study Officials

• David Cutler, MD

  Kinex Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 3, 2015
• Study Start: December 2, 2015
• Primary Completion: July 25, 2019
• Study Completion: June 30, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

PA (1); PE (3); DO (3); EL (2); GU (7); CL (5); HO (2); CO (4); AR (15); EC (3)