IV Paclitaxel

DRUG3 trials

Sponsors

Athenex, Inc., Daehwa Pharmaceutical Co., Ltd., Health Hope Pharma

Conditions

Metastatic Breast CancerRecurrent or Metastatic Breast Cancer

Phase 2

Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer

CompletedNCT03326102

Daehwa Pharmaceutical Co., Ltd.Recurrent or Metastatic Breast Cancer

Start: 2018-07-06End: 2022-12-13Updated: 2024-02-16

Phase 3

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

CompletedNCT02594371

Athenex, Inc.Metastatic Breast Cancer

Start: 2015-12-02End: 2022-06-30Updated: 2022-08-03

Oral Paclitaxel + Encequidar vs IV Paclitaxel in Treatment of HER2 Negative Metastatic Breast Cancer

Not yet recruitingNCT06835400

Health Hope PharmaMetastatic Breast Cancer

Start: 2025-09-30End: 2029-05-31Target: 340Updated: 2025-07-11

Related Papers

Correction: Overcoming chemoresistance in esophageal cancer with synergistic strategies

Frontiers in Immunology2026-07-03

OPERA: a phase II study of DHP107 (oral paclitaxel) versus intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer.

2026-03-30

Open-Label, Randomized, Multicenter, Phase III Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients With Metastatic Breast Cancer

Journal of Clinical Oncology2022-07-2020 citations

Abstract PS13-16: Pharmacokinetic evaluation of an oral paclitaxel DHP107 (Liporaxel®) in patients with recurrent or metastatic breast cancer (MBC): Phase II study (OPERA, NCT03326102)

Cancer Research2021-02-151 citations

Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study)

Therapeutic Advances in Medical Oncology2021-01-0112 citations

Abstract GS6-01: Oral paclitaxel with encequidar: The first orally administered paclitaxel shown to be superior to IV paclitaxel on confirmed response and survival with less neuropathy: A phase III clinical study in metastatic breast cancer

Cancer Research2020-02-1511 citations

Abstract OT1-05-02: A phase II study to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Liporaxel®, oral paclitaxel) compared to IV paclitaxel in patients with recurrent or metastatic breast cancer: OPERA (NCT03326102)

Cancer Research2020-02-152 citations

KX-ORAX-001: An open label, randomized, multicenter, phase III registrational study to determine the safety, tolerability, and tumor response of oraxol (HM30181A + oral paclitaxel) and its comparability to IV paclitaxel in patients with metastatic breast cancer (MBC).

Journal of Clinical Oncology2019-05-202 citations