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

NCT ID: NCT04168957

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2020-11-12

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.

Conditions

Breastcancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oraxol

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

Group Type: EXPERIMENTAL

Oraxol

Intervention Type: DRUG

Oraxol (oral paclitaxel + oral HM30181AK-US)

Paclitaxel: supplied as capsules HM30181 methanesulfonate monohydrate: supplied as HM30181AK-US tablets

Interventions

Oraxol

Oraxol (oral paclitaxel + oral HM30181AK-US)

Paclitaxel: supplied as capsules HM30181 methanesulfonate monohydrate: supplied as HM30181AK-US tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Breast cancer patients who have completed Study KX-ORAX-007 without disease progression at Week 16, who wish to continue Oraxol treatment.

2. Signed written informed consent.

3. Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days.

4. 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

1. Have not recovered from unacceptable toxicity associated with previous Oraxol treatment in KX-ORAX-007.

2. Are currently receiving other medications intended for the treatment of their malignancy.

3. Women who are pregnant or breastfeeding.

4. 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.

5. 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.

6. 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.

7. Known allergic reaction or intolerance to study medication components.

8. Known allergic reaction or intolerance to contrast media.

9. Patients who, in the Investigator's opinion, are not suitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PharmaEssentia

INDUSTRY

Sponsor Role: collaborator

Athenex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Cutler, MD

Role: STUDY_DIRECTOR

Athenex, Inc.

Locations

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Tr-Service General Hospital

Taipei, , Taiwan

Taipei Veterans Generla Hospital

Taipei, Taiwan, 11217, , Taiwan

Countries

Taiwan

Other Identifiers

U1111-1180-5217

Identifier Type: OTHER

Identifier Source: secondary_id

KX-ORAX-008

Identifier Type: -

Identifier Source: org_study_id