A Study of Oraxol® in Gastric Cancer Patients

Phase 1/2 Unknown 53 enrolled Hanmi Pharmaceutical Company Limited

NaSingle-groupOpen-labelTreatment

Summary

The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.

Timeline

Start: 2009-05
Primary completion: 2012-03
Completion: 2012-12

Publications

Lee KW, Lee KH, Zang DY, Park YI, Shin DB, Kim JW, Im SA, Koh SA, Yu KS, Cho JY, Jung JA, Bang YJ. Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer. Oncologist. 2015 Aug;20(8):896-7. doi: 10.1634/theoncologist.2015-0202. Epub 2015 Jun 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	90 mg/m2	Oral
Subject	Paclitaxel	Small molecule	120 mg/m2	Oral
Subject	Paclitaxel	Small molecule	150 mg/m2	Oral
Background	HM30181AK	Unknown	15 mg	—

A Study of Oraxol® in Gastric Cancer Patients

Summary

Timeline

Publications

Drugs

Indications