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Oraxol

DRUG11 trials

Sponsors

Kinex Pharmaceuticals Inc., Athenex, Inc., Health Hope Pharma

Conditions

Angiosarcoma of SkinBreastcancerEsophageal CancerGastric CancerGastro-esophageal CancerMetastatic Breast CancerSolid TumorSolid Tumor, Adult

Phase 1

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
CompletedNCT01967043
Kinex Pharmaceuticals Inc.Solid Tumor
Start: 2013-10-31End: 2016-09-30Target: 34Updated: 2016-12-16
A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies
CompletedNCT02730481
Athenex, Inc.Solid Tumor
Start: 2016-03-31End: 2021-05-31Updated: 2021-09-13
Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers
NCT02970539
Athenex, Inc.Esophageal Cancer, Gastric Cancer, Gastro-esophageal Cancer
Start: 2016-12-08End: 2022-12-31Updated: 2022-02-16
A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients
CompletedNCT03165955
Health Hope PharmaBreastcancer
Start: 2017-05-09End: 2018-11-22Updated: 2025-03-12
Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors
TerminatedNCT03588039
Athenex, Inc.Solid Tumor
Start: 2018-10-25End: 2023-05-12Updated: 2023-05-19
The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
TerminatedNCT03892018
Athenex, Inc.Solid Tumor, Adult
Start: 2019-08-05End: 2023-05-12Updated: 2023-05-22
An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007
TerminatedNCT04168957
Athenex, Inc.Breastcancer
Start: 2017-10-25End: 2020-11-12Updated: 2022-03-03
A PK Study of Oraxol in Breast Cancer Patients
CompletedNCT04993040
Athenex, Inc.Breastcancer
Start: 2019-04-22End: 2020-12-09Updated: 2021-08-06

Phase 2

A Study of Oraxol in Subjects With Cutaneous Angiosarcoma
CompletedNCT03544567
Athenex, Inc.Angiosarcoma of Skin
Start: 2018-12-21End: 2023-05-12Updated: 2023-05-19
A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients
CompletedNCT04180384
Athenex, Inc.Solid Tumor
Start: 2015-09-23End: 2021-06-15Updated: 2021-07-29

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

Related Papers

Oral paclitaxel and encequidar in patients with breast cancer: a pharmacokinetic, safety, and antitumor activity study
Therapeutic Advances in Medical Oncology2023-01-014 citations
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
A novel oral paclitaxel and HM10381 (oraxel)-treated metastatic breast cancer: A phase I study (KX-ORAX-CN-007).
Journal of Clinical Oncology2022-06-01
A phase II study of oraxol in the treatment of unresectable cutaneous angiosarcoma.
Journal of Clinical Oncology2020-05-2013 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 4717: Effective preclinical management of angiosarcoma with oral paclitaxel
Cancer Research2019-07-01
Abstract 4717: Effective preclinical management of angiosarcoma with oral paclitaxel
Experimental and Molecular Therapeutics2019-07-01
Oral paclitaxel in the treatment of metastatic breast cancer (MBC) patients.
Journal of Clinical Oncology2019-05-2011 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
A phase Ib study of oraxol in combination with ramucirumab in patients with gastric or esophageal cancers who failed previous chemotherapy.
Journal of Clinical Oncology2019-05-20
Oral paclitaxel and HM30181A demonstrate clinical activity in metastatic breast cancer (MBC) patients
Annals of Oncology2018-10-01
A phase I study to evaluate safety, tolerability, pharmacokinetics and activity of oraxol in patients (pts) with advanced malignancies.
Journal of Clinical Oncology2018-05-204 citations