Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display session 2

2669 - A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric or Esophageal Cancers who failed previous chemotherapy


29 Sep 2019


Poster Display session 2


Tumour Site

Oesophageal Cancer;  Gastric Cancer


Ming Huang Chen


Annals of Oncology (2019) 30 (suppl_5): v253-v324. 10.1093/annonc/mdz247


M.H. Chen1, Y. Chao1, L. Tenner2, N.A. Hung3, D. Cutler4, D. Kramer4, M.R. Kwan4, C. Hung5

Author affiliations

  • 1 Deparment Of Oncology, Taipei Veterans General Hospital, 11217 - Taipei City/TW
  • 2 Cancer Therapy & Research Center, University of Texas Health Science Center at San Antonio, San Antonio/US
  • 3 University Of Otago, University of Otago, Dunedin/NZ
  • 4 Athenex Inc, Athenex Inc, Buffalo/US
  • 5 Zenith Technology Corporation Limited, Zenith Technology Corporation Limited, Dunedin/NZ


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 2669


Oraxol consists of oral paclitaxel administered with the novel P-glycoprotein inhibitor HM30181A which enables the oral absorption of paclitaxel. Ramucirumab (RAM) + intravenous paclitaxel is FDA approved 2nd line treatment of gastric cancer. Oraxol 200mg/m2 days 1-3, weekly has similar exposure to weekly paclitaxel 80/m2 intravenously. This study was to determine the maximum tolerated dose (MTD) of Oraxol + RAM.


17 patients with gastric or esophageal cancers who failed prior fluoropyrimidine or platinum containing chemotherapies were studied. Dose escalation followed the standard 3 + 3 design: Cohort 1: Oraxol 200mg/m2 days 1-3, weekly. Cohort 2: Oraxol 250mg/m2 days 1-3, weekly. Cohort 3: Oraxol 300mg/m2 days 1-3, weekly. RAM 8 mg/kg IV every 2 weeks was co-administered in all patients. Dose limiting toxicity (DLT) were assessed by week 4. Adverse events (AEs) were assessed per CTCAE v4.03 and response by RECIST v1.1.


Cohort 1: One febrile neutropenia (DLT) occurred in 6 patients. Partial response (PR)=2/6, stable disease (SD)=1/6 and progressive disease (PD)=3/6. Cohort 2: One grade-3 neutropenia with treatment delay (DLT) occurred in 7 pts. PR = 3/6 and PD = 3/6 in 6 evaluable patients. Cohort 3: Two DLT (febrile neutropenia and grade-3 gastric hemorrhage) occurred in 3 patients. The MTD of Oraxol was 300mg/m2 days 1-3, weekly in combination with RAM. All patients in this study had complete recovery of their DLT. Oraxol PK did not increase significantly in Cohort-2 and Cohort-3.


Based on the lack of significant increase in exposure to Oraxol at higher doses, with similar efficacy and DLT in Cohorts 1 and 2, an extension study using Oraxol 200mg/m2 Days 1-3, weekly + Ramucirumab 8 mg/kg every 2 weeks as in Cohort-1 is initiated.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Athenex Inc.


Athenex Inc.


All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.