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

NCT04168957 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-03-03

No results posted yet for this study

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

Interventions

DRUG

Oraxol

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

Sponsors & Collaborators

  • PharmaEssentia

    collaborator INDUSTRY

  • Athenex, Inc.

    lead INDUSTRY

Principal Investigators

  • David Cutler, MD · Athenex, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2019-08-27
Completion
2020-11-12
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04168957 on ClinicalTrials.gov