drugset

drugset / Trial / NCT02594371

Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer

NCT02594371 ↗

Phase 3 Completed 402 enrolled Athenex, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic breast cancer

Timeline

Start: 2015-12-02
Primary completion: 2019-07-25
Completion: 2022-06-30

Publications

Rugo HS, Umanzor GA, Barrios FJ, Vasallo RH, Chivalan MA, Bejarano S, Ramirez JR, Fein L, Kowalyszyn RD, Kramer ED, Wang H, Kwan MR, Cutler DL; Oraxol Study Consortium Investigators. Open-Label, Randomized, Multicenter, Phase III Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients With Metastatic Breast Cancer. J Clin Oncol. 2023 Jan 1;41(1):65-74. doi: 10.1200/JCO.21.02953. Epub 2022 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HM30181AK	Unknown	15 mg	Oral
Subject	Paclitaxel	Small molecule	175 mg/m2	Oral
Subject	Paclitaxel	Small molecule	205 mg/m2	Oral

Indications