NCT04168957

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Athenex, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2017-10-25
• Primary completion: 2019-08-27
• Completion: 2020-11-12
• First posted: 2019-11-19
• Last updated: 2022-03-03

Locations

5 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study