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

Date

29 Sep 2019

Session

Poster Display session 2

Presenters

Ming Huang Chen

Citation

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

Authors

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
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Background

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.

Methods

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.

Results

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.

Conclusions

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

NCT02970539.

Editorial acknowledgement

Legal entity responsible for the study

Athenex Inc.

Funding

Athenex Inc.

Disclosure

All authors have declared no conflicts of interest.

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