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Phase II study of NK105, a paclitaxel-incorporating micellar nanoparticle, for previously treated advanced or recurrent gastric cancer

  • PHASE II STUDIES
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Summary

Purpose NK105 is a new drug delivery system formulation for paclitaxel (PTX) whose recommended dose (RD)　is 150 mg PTX equivalent/m2 administered every 3 weeks, as determined in a phase I trial. This study aimed to evaluate the efficacy and safety of NK105 in patients with advanced gastric cancer after failure of first-line chemotherapy. Experimental design Eligible patients had measurable disease and one chemotherapeutic regimen except taxane. NK105 (150 mg PTX equivalent/m2) was administered by a 30-minute intravenous infusion every 3 weeks without anti-allergic premedication until disease progression, unacceptable toxicity or patient refusal. The primary efficacy endpoint was best overall response rate (ORR) post baseline. The secondary endpoints were progression-free survival (PFS), time to treatment failure (TTF) and overall survival (OS). All adverse events were reported using CTCAE v3.0. Results Between November 2007 and July 2009, 57 patients were enrolled and 56 were evaluable for efficacy. Two complete responses and 12 partial responses were observed for an ORR of 25%. The median PFS was 3.0 months, the median TTF was 2.8 months, and the median OS was 14.4 months. Drug related toxicity was mainly mild (grades 1–2) to severe (grades 3–4); other data: neutropenia (64.9%); leukopenia (17.5%); lymphopenia (8.8%); neuropathy-sensory (1.8%); fatigue (3.5%); and stomatitis (1.8%). There were no treatment-related deaths. Conclusions This study of NK105 (150 mg PTX equivalent/m2) proves the concept for the modest activity and tolerability of a new drug delivery system formulation for PTX. A phase III trial will be evaluated to clarify survival benefit.

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Acknowledgments of research support

We thank all the patients and families who participated in this trial. We are indebted to Dr. Ichinosuke Hyodo, Dr. Kuniaki Shirao, and Dr. Hirohumi Fujii for their help in the assessment of efficacy and evaluation of safety. This work was funded by Nippon Kayaku Co., Ltd. (Tokyo, Japan).

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Authors and Affiliations

  1. Gastrointestinal Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, 104-0045, Tokyo, Japan

    Ken Kato, Tetsuya Hamaguchi & Yasuhiro Shimada

  2. Department of Cancer Chemotherapy, Cancer Institute Hospital Tokyo, Tokyo, Japan

    Keisho Chin

  3. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan

    Takaki Yoshikawa

  4. Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan

    Kensei Yamaguchi

  5. Department of Medical Oncology, Tonan Hospital, Sapporo, Japan

    Yasushi Tsuji

  6. Gastrointestinal Oncology and Medical Oncology Division, National Kyushu Cancer Center, Fukuoka, Japan

    Taito Esaki

  7. Department of Medical Oncology, Saiseikai Kumamoto Hospital, Kumamoto, Japan

    Kenji Sakai

  8. Department of Surgery, Health Insurance Hitoyoshi General Hospital, Kumamoto, Japan

    Masami Kimura

  9. Investigative Treatment Division, National Cancer Center Hospital East, Chiba, Japan

    Yasuhiro Matsumura

  10. Pharmaceutical Development, Nippon Kayaku Co., Ltd., Tokyo, Japan

    Ryuji Ikeda

Authors
  1. Ken Kato
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  2. Keisho Chin
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Correspondence to Ken Kato.

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Kato, K., Chin, K., Yoshikawa, T. et al. Phase II study of NK105, a paclitaxel-incorporating micellar nanoparticle, for previously treated advanced or recurrent gastric cancer. Invest New Drugs 30, 1621–1627 (2012). https://doi.org/10.1007/s10637-011-9709-2

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  • DOI: https://doi.org/10.1007/s10637-011-9709-2

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