A Phase I/IIa Study of DHP107, a Novel Oral Paclitaxel Formulation, in Patients with Advanced Solid Tumors or Gastric Cancer

作者：Ryu Min Hee; Ryoo Baek Yeol; Kim Tae Won; Kim Sung Bae; Lim Hyeong Seok; Bae Kyun Seop; Park Sook Ryun; Jo Yeong Woo; Cho Hyun Ju; Kang Yoon Koo^*

来源：Oncologist, 2017, 22(2): 129-E8.

DOI：10.1634/theoncologist.2016-0273

Background. We evaluated the maximum tolerated dose (MTD) of DHP107, a novel oral paclitaxel formulation, and the efficacy and safety of the agent in patients with advanced solid tumors.
Patients and Methods. Phase I study: cohorts of 3-6 patients with advanced solid tumors received escalating DHP107 doses. Phase IIa study: patients with measurable advanced gastric cancer received DHP107, 200 mg/m(2) b.i.d., on days 1, 8, and 15 every 4 weeks. Pharmacokinetics, safety, and efficacy were analyzed.
Results. Phase I: 17 patients received a dose-escalating regimen of DHP107, 150-250 mg/m(2) b.i.d. Dose-limiting toxicities were neutropenia and febrile neutropenia. The MTD (recommended dose) for phase IIa was 200 mg/m(2) b.i.d. Phase IIa: 11 patients with measurable advanced gastric cancer in whom first-line therapy failed received DHP107 (MTD). Three confirmed partial responses were observed. Median progression-free survival of gastric cancer patients (n516) treated at the MTD was 2.97 (95% confidence interval, 1.67-5.40) months (Fig. 1). The most frequent grade 3/4 adverse events were neutropenia (35.3%) and leukopenia (17.6%) at the MTD (phase I and IIa combined; n517).
Conclusion. DHP107 showed good antitumor efficacy and was tolerable. The MTD (200 mg/m(2) b.i.d.) is recommended for use in further studies comparing DHP107 with standard intravenous paclitaxel therapy.

• 出版日期2017