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

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-003-17
• Date of registration: 02/06/2017
• Prospective Registration: Yes
• Primary sponsor: Athenex,
• Public 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
• Scientific 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
• Date of first enrolment: 28/06/2017
• Target sample size: 30
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=003-17
• Study type: Interventional
• Study design: This is a Phase 3, open-label, randomized, multicenter study in 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.
• Phase: III

Countries of recruitment

Argentina, Chile, Dominican Republic, Guatemala, Honduras

Contacts

• Name: JUAN LOPEZ REYES
• Affiliation: ATHENEX CIDAL PERU S.A.C.

• Name: JUAN LOPEZ REYES
• Affiliation: ATHENEX CIDAL PERU S.A.C.

Key inclusion & exclusion criteria

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 as per RECIST v1.1 criteria

5. Adequate hematological status as demonstrated by:

• ANC ≥1.5 x 109/L

• Platelet count ≥100 x 109/L

• Hemoglobin ≥10 g/L

6. Adequate liver function as demonstrated by:

• Total bilirubin of ≤1.5 mg/dL or ≤2.0 mg/dL for subjects with liver metastasis

• Alanine aminotransferase and aspartate aminotransferase ≤3 x upper limit of normal (ULN) or ≤5 x ULN if liver metastasis is present

• Alkaline phosphatase ≤3 x ULN or ≤5 x ULN if bone metastasis is present

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 judgment 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 (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.

11. Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening/Baseline and within 72 hours before dosing on designated weeks

Exclusion criteria:
1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous 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. 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. 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-glycoprotein (P-gp) inhibitor or
inducer within 14 days of starting Day 1, Week 1 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 dosing in the study
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 Day 1, Week 1 treatment
12. Taking a medication known to be a strong inhibitor (eg, gemfibrozil) or inducer
(eg, rifampin) of CYP2C8 within 14 days of starting Day 1, Week 1 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 gastrointestinal (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 old, 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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

C50

-C50 Malignant neoplasm of breast
Malignant neoplasm of breast

Malignant neoplasm of breast

Intervention(s)

Subjects will be randomized in a 2:1 ratio to 1 of the 2 following treatments for 18 to 21 weeks during the Treatment Period:

1) Oraxol - 15 mg oral HM30181 methanesulfonate monohydrate plus 205 mg/m2 oral paclitaxel administered once daily for 3 consecutive days every week during Weeks 1 through 18 or 21 (HM30181 will be administered 1 hour before oral paclitaxel on all dosing days.); or

2) IV paclitaxel - 175 mg/m2 IV paclitaxel (as Taxol or generic) as a one-time infusion over 3 hours on Day 1 of every 3rd week (Weeks 1, 4, 7, 10, 13, 16, or 19)

Secondary ID(s)

NCT02594371

1111-1162-7764

Source(s) of Monetary Support

Athenex

Ethics review

Status: Approved
Approval date: 20/09/2016
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 29/09/2016
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 12/12/2016
Contact:

[e-mail]

Hospital Nacional Arzobispo Loayza

88339014 - 3301677

[e-mail]

Status: Approved
Approval date: 16/04/2019
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Results

• Results available: Yes
• Date Completed: 30/05/2022