Back to results

An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007

Primary Purpose

Breastcancer

Status

Terminated

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

Oraxol

About this trial

This is an interventional treatment trial for Breastcancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Breast cancer patients who have completed Study KX-ORAX-007 without disease progression at Week 16, who wish to continue Oraxol treatment.
Signed written informed consent.
Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days.
Patients 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.

Exclusion Criteria:

Have not recovered from unacceptable toxicity associated with previous Oraxol treatment in KX-ORAX-007.
Are currently receiving other medications intended for the treatment of their malignancy.
Women who are pregnant or breastfeeding.
Taking any following prohibited medications:
- Strong inhibitors (eg, ketoconazole) or strong inducers (eg, rifampin or St. John's Wort) of CYP3A4 (within 2 weeks prior to the start of dosing in the study).
- Strong inhibitors (eg, gemfibrozil) or strong inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study).
- Strong P-gp inhibitors or inducers.
- An oral medication with a narrow therapeutic index known to be a P-gp substrate (eg, digoxin, dabigatran) within 24 hours prior to start of dosing in the study.
Use of warfarin. Patients 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.
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.
Known allergic reaction or intolerance to study medication components.
Known allergic reaction or intolerance to contrast media.
Patients who, in the Investigator's opinion, are not suitable for participation in this study.

Sites / Locations

Taipei Medical University Shuang Ho Hospital
China Medical University Hospital
Taipei Veterans Generla Hospital
Taipei Medical University Hospital
Tr-Service General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oraxol

Arm Description

Subjects in KX-ORAX-008 will begin treatment at the last oral paclitaxel dose they received in Study KX-ORAX-007.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Safety assessments will consist of determining and recording all adverse events and SAEs (adverse events will be graded on a 5-point scale according to CTCAE v4.03); Evaluate the safety of Oraxol. Number of participants with treatment-related adverse events.

Secondary Outcome Measures

Activity: Tumor response

The number of patients with CR or PR at any post-baseline assessments after the start of treatment in KX-ORAX-007. Computed tomography (CT) and/or magnetic resonance imaging (MRI) scans will be conducted on Day 1 every 8 weeks until documented progression. Tumor status will be evaluated using RECIST v1.1 criteria. In addition to using the RECIST criteria, the Investigator must consider all other clinical information as part of tumor status evaluation.

Full Information

NCT ID

NCT04168957

First Posted

April 13, 2018

Last Updated

February 15, 2022

Sponsor

Athenex, Inc.

Collaborators

PharmaEssentia

1. Study Identification

Unique Protocol Identification Number

NCT04168957

Brief Title

An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007

Official Title

An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

No need to complete the overall survival (OS) follow-up as the sample size was too small to interpret OS.

Study Start Date

October 25, 2017 (Actual)

Primary Completion Date

August 27, 2019 (Actual)

Study Completion Date

November 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Athenex, Inc.

Collaborators

PharmaEssentia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

KX-ORAX-008 is an extension study of patients who completed KX-ORAX-007 without disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and who wish to continue Oraxol treatment.

Detailed Description

This is a multicenter, open-label, extension study offering the option of further Oraxol treatment to breast cancer patients who have completed the KX-ORAX-007 Oraxol study with complete response (CR), partial response (PR), or stable disease (SD), and who wish to continue further Oraxol treatment. The study contains 3 periods: the Screening Period, the Treatment Period, and the Follow-up Period. A Final Visit will occur within 7 days of the last dose of study treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breastcancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oraxol

Arm Type

Experimental

Arm Description

Subjects in KX-ORAX-008 will begin treatment at the last oral paclitaxel dose they received in Study KX-ORAX-007.

Intervention Type

Drug

Intervention Name(s)

Oraxol

Intervention Description

Oraxol (oral paclitaxel + oral HM30181AK-US) Paclitaxel: supplied as capsules HM30181 methanesulfonate monohydrate: supplied as HM30181AK-US tablets

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

Time Frame

From screening until final visit (within 72 hours prior to Day 21 of Study Period 2, preferably before the participant receives any additional chemotherapy)

Secondary Outcome Measure Information:

Title

Activity: Tumor response

Description

Time Frame

from the start of treatment in KX-ORAX-007 until follow up visit every 2 months after patient withdrawal up to 10 months.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Breast cancer patients who have completed Study KX-ORAX-007 without disease progression at Week 16, who wish to continue Oraxol treatment. Signed written informed consent. Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days. Patients 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. Exclusion Criteria: Have not recovered from unacceptable toxicity associated with previous Oraxol treatment in KX-ORAX-007. Are currently receiving other medications intended for the treatment of their malignancy. Women who are pregnant or breastfeeding. Taking any following prohibited medications: Strong inhibitors (eg, ketoconazole) or strong inducers (eg, rifampin or St. John's Wort) of CYP3A4 (within 2 weeks prior to the start of dosing in the study). Strong inhibitors (eg, gemfibrozil) or strong inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study). Strong P-gp inhibitors or inducers. An oral medication with a narrow therapeutic index known to be a P-gp substrate (eg, digoxin, dabigatran) within 24 hours prior to start of dosing in the study. Use of warfarin. Patients 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. 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. Known allergic reaction or intolerance to study medication components. Known allergic reaction or intolerance to contrast media. Patients who, in the Investigator's opinion, are not suitable for participation in this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Cutler, MD

Organizational Affiliation

Athenex, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Taipei Medical University Shuang Ho Hospital

City

New Taipei City

ZIP/Postal Code

23561

Country

Taiwan

Facility Name

China Medical University Hospital

City

Taichung city

Country

Taiwan

Facility Name

Taipei Veterans Generla Hospital

City

Taipei, Taiwan, 11217

Country

Taiwan

Facility Name

Taipei Medical University Hospital

City

Taipei

Country

Taiwan

Facility Name

Tr-Service General Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007

We'll reach out to this number within 24 hrs