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

NCT04168957 | Terminated Phase 1 FDA Drug

• 2 other identifiers: KX-ORAX-008U1111-1180-5217
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 5

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.

Conditions

Breastcancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Activity: Tumor response

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

Study Arms (1)

Oraxol

EXPERIMENTAL

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

Drug: Oraxol

Interventions

Oraxol DRUG

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

Oraxol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Athenex, Inc.: lead
• PharmaEssentia: collaborator

Study Sites (5)

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

Tr-Service General Hospital

Taipei, Taiwan

Location

Taipei Veterans Generla Hospital

Taipei, Taiwan, 11217, Taiwan

Location

Study Officials

• David Cutler, MD

  Athenex, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: November 19, 2019
• Study Start: October 25, 2017
• Primary Completion: August 27, 2019
• Study Completion: November 12, 2020
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

TW (5)