title: Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer.
abstract: BACKGROUND
  Oraxol consists of paclitaxel and HM30181A, a P-glycoprotein inhibitor, to increase the oral bioavailability of paclitaxel. This phase I/II study (HM-OXL-201) was conducted to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Oraxol. In addition, we investigated the efficacy and safety of Oraxol as second-line chemotherapy for metastatic or recurrent gastric cancer (GC).
  
  
  METHODS
  In the phase I component, paclitaxel was orally administered at escalating doses (90, 120, or 150 mg/m(2) per day) with a fixed dose (15 mg/day) of HM30181A. Oraxol was administrated 6 times per cycle (days 1, 2, 8, 9, 15, and 16) every 4 weeks. In the phase II component, the efficacy and safety of Oraxol were evaluated.
  
  
  RESULTS
  In the phase I component, the MTD could not be determined. Based on toxicity and pharmacokinetic data, the RP2D of oral paclitaxel was determined to be 150 mg/m(2). In the phase II component, 4 of 43 patients (9.3%) achieved partial responses. Median progression-free survival and overall survival were 2.6 and 10.7 months, respectively. Toxicity profiles were favorable, and the most common drug-related adverse events (grade ≥3) were neutropenia and diarrhea.
  
  
  CONCLUSIONS
  Oraxol exhibited modest efficacy and favorable toxicity profiles as second-line chemotherapy for GC.
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea;
authors.forename: Keun-Wook
authors.initials: KW
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Yeungnam University Hospital, Daegu, Republic of Korea;
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea;
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Zang
authors.affiliation: Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea;
authors.forename: Young Iee
authors.initials: YI
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Gachon University Gil Hospital, Incheon, Republic of Korea;
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea;
authors.forename: Jin Won
authors.initials: JW
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea;
authors.forename: Seock-Ah
authors.initials: SA
authors.lastname: Im
authors.affiliation: Department of Internal Medicine, Yeungnam University Hospital, Daegu, Republic of Korea;
authors.forename: Sung Ae
authors.initials: SA
authors.lastname: Koh
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea; bangyj@snu.ac.kr.
authors.forename: Kyung-Sang
authors.initials: KS
authors.lastname: Yu
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea;
authors.forename: Joo-Youn
authors.initials: JY
authors.lastname: Cho
authors.affiliation: Clinical Research Team, Hanmi Pharmaceutical Co., Ltd., Seoul, Republic of Korea.
authors.forename: Jin-A
authors.initials: JA
authors.lastname: Jung
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; bangyj@snu.ac.kr.
authors.forename: Yung-Jue
authors.initials: YJ
authors.lastname: Bang
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000188:drug therapy*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel