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  1. Article

    Open Access

    Japanese subgroup analysis of a phase III study of S-1 versus docetaxel in non-small cell lung cancer patients after platinum-based treatment: EAST-LC

    The East Asia S-1 Trial in Lung Cancer (EAST-LC) was a randomized phase III study conducted in East Asia that demonstrated the non-inferiority of S-1 to docetaxel in previously treated patients with advanced n...

    Shunichi Sugawara, Kazuhiko Nakagawa in International Journal of Clinical Oncology (2019)

  2. Article

    Erratum to: Final overall survival in JO22903, a phase II, open-label study of first-line erlotinib for Japanese patients with EGFR mutation-positive non-small-cell lung cancer

    Noboru Yamamoto, Koichi Goto, Makoto Nishio in International Journal of Clinical Oncology (2017)

  3. Article

    Open Access

    Final overall survival in JO22903, a phase II, open-label study of first-line erlotinib for Japanese patients with EGFR mutation-positive non-small-cell lung cancer

    In Japan, the clinical efficacy of erlotinib monotherapy in epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer was demonstrated in the phase II JO22903 trial, which reported a me...

    Noboru Yamamoto, Koichi Goto, Makoto Nishio in International Journal of Clinical Oncology (2017)

  4. No Access

    Article

    Phase I study of the second-generation, recombinant, human EGFR antibody necitumumab in Japanese patients with advanced solid tumors

    To establish the safety and pharmacokinetic profile of necitumumab in Japanese patients with advanced solid tumors not responsive to standard therapy or for which no standard therapy was available.

    Yosuke Tamura, Hiroshi Nokihara, Kazunori Honda in Cancer Chemotherapy and Pharmacology (2016)

  5. Article

    Open Access

    A phase 1 study of lenvatinib, multiple receptor tyrosine kinase inhibitor, in Japanese patients with advanced solid tumors

    This phase 1 study aimed to assess the tolerability, safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of lenvatinib capsules in Japanese patients with solid tumors when administered or...

    Shinji Nakamichi, Hiroshi Nokihara, Noboru Yamamoto in Cancer Chemotherapy and Pharmacology (2015)

  6. No Access

    Article

    Phase 1 study of galunisertib, a TGF-beta receptor I kinase inhibitor, in Japanese patients with advanced solid tumors

    Inhibition of transforming growth factor-beta receptor I (TGF-beta RI)-mediated signaling pathways blocks tumor growth and metastases in nonclinical studies. Galunisertib (LY2157299), a small molecule inhibito...

    Yutaka Fujiwara, Hiroshi Nokihara, Yasuhide Yamada in Cancer Chemotherapy and Pharmacology (2015)

  7. Article

    Open Access

    A phase 1 study evaluating the pharmacokinetics and preliminary efficacy of veliparib (ABT-888) in combination with carboplatin/paclitaxel in Japanese subjects with non-small cell lung cancer (NSCLC)

    Veliparib is a potent, orally bioavailable PARP inhibitor that enhances efficacy of DNA-damaging chemotherapeutic agents. The study objectives were to determine the recommended phase 2 dose (RPTD) of veliparib...

    Hidenori Mizugaki, Noboru Yamamoto in Cancer Chemotherapy and Pharmacology (2015)

  8. No Access

    Article

    Comparison of the pharmacokinetics of erlotinib administered in complete fasting and 2 h after a meal in patients with lung cancer

    The recommended dose of erlotinib is 150 mg daily either 1 h before a meal (complete fasting) or 2 h after a meal (2 h post-meal), because of the food effect.

    Yuki Katsuya, Yutaka Fujiwara, Kuniko Sunami in Cancer Chemotherapy and Pharmacology (2015)

  9. No Access

    Article

    A phase I study of resminostat in Japanese patients with advanced solid tumors

    This study was performed to evaluate the safety and determine the recommended dose (RD) of resminostat monotherapy, an oral histone deacetylase (HDAC) inhibitor, in Japanese patients with advanced solid tumors.

    Satoru Kitazono, Yutaka Fujiwara, Shinji Nakamichi in Cancer Chemotherapy and Pharmacology (2015)

  10. Article

    Open Access

    Pharmacodynamic change in plasma angiogenic proteins: a dose-escalation phase 1 study of the multi-kinase inhibitor lenvatinib

    Lenvatinib (E7080), an oral multi-kinase inhibitor, has inhibitory action on tumor cell proliferation and tumor angiogenesis in preclinical models. We evaluated correlations between pharmacodynamic (PD) biomar...

    Noriyuki Koyama, Kenichi Saito, Yuki Nishioka, Wataru Yusa, Noboru Yamamoto in BMC Cancer (2014)

  11. No Access

    Article

    A phase 1 study of linifanib in combination with carboplatin/paclitaxel as first-line treatment of Japanese patients with advanced or metastatic non-small cell lung cancer (NSCLC)

    Linifanib is a potent, orally active, and selective inhibitor of vascular endothelial growth factor and platelet-derived growth factor receptor kinase activities with clinical efficacy in non-small cell lung c...

    Hidehito Horinouchi, Noboru Yamamoto in Cancer Chemotherapy and Pharmacology (2014)

  12. No Access

    Article

    A phase 1 and dose-finding study of LY2523355 (litronesib), an Eg5 inhibitor, in Japanese patients with advanced solid tumors

    Eg5, a mitotic motor kinesin protein, plays an essential role in bipolar spindle formation in the M phase of the cell cycle. LY2523355 (litronesib) is an allosteric inhibitor of Eg5. This phase 1 and dose-find...

    Hiroshi Wakui, Noboru Yamamoto, Satoru Kitazono in Cancer Chemotherapy and Pharmacology (2014)

  13. Article

    Open Access

    Phase 1 and dose-finding study of patritumab (U3-1287), a human monoclonal antibody targeting HER3, in Japanese patients with advanced solid tumors

    Patritumab (U3-1287) is a human epidermal growth factor receptor-3 (HER3)-targeted antibody that blocks ligand-associated activation of HER3. This open-label, phase 1 and dose-finding study (ClinicalTrials.jp ...

    Hiroshi Wakui, Noboru Yamamoto, Shinji Nakamichi in Cancer Chemotherapy and Pharmacology (2014)

  14. No Access

    Article

    Phase I and pharmacokinetic/pharmacodynamic study of RO5126766, a first-in-class dual Raf/MEK inhibitor, in Japanese patients with advanced solid tumors

    RO5126766, a highly selective dual Raf and MEK inhibitor, is a first-in-class tandem mitogen-activated protein kinase signaling pathway inhibitor. The objectives of this phase I study were to determine maximum...

    Kazunori Honda, Noboru Yamamoto, Hiroshi Nokihara in Cancer Chemotherapy and Pharmacology (2013)

  15. No Access

    Article

    Phase I study of oral gemcitabine prodrug (LY2334737) in Japanese patients with advanced solid tumors

    LY2334737 is an oral gemcitabine prodrug. This Phase I study assessed the safety and tolerability of LY2334737 in Japanese patients with solid tumors and evaluated pharmacokinetics (PK), pharmacodynamics, and ...

    Noboru Yamamoto, Hiroshi Nokihara, Yasuhide Yamada in Cancer Chemotherapy and Pharmacology (2013)

  16. Article

    Open Access

    Epidermal growth factor receptor variant type III markedly accelerates angiogenesis and tumor growth via inducing c-myc mediated angiopoietin-like 4 expression in malignant glioma

    Expression of the constitutively activated mutant EGFR variant III (EGFRvIII), the most common mutation in glioblastoma multiforme (GBMs), has been clinically correlated with tumor proliferation, invasion, and...

    Yasufumi Katanasaka, Yasuo Kodera, Yuka Kitamura, Tatsuya Morimoto in Molecular Cancer (2013)

  17. Article

    Open Access

    A phase I study of BMS-690514 in Japanese patients with advanced or metastatic solid tumors

    BMS-690514 is a novel oral tyrosine kinase inhibitor of ErbB and vascular endothelial growth factor receptor. This open-label phase I dose-escalation study (ClinicalTrials.gov Identifier: NCT00516451) aimed to...

    Hiroshi Nokihara, Noboru Yamamoto, Yasuhide Yamada in Cancer Chemotherapy and Pharmacology (2012)

  18. Article

    Open Access

    An open-label, phase 1 study evaluating safety, tolerability, and pharmacokinetics of linifanib (ABT-869) in Japanese patients with solid tumors

    This phase 1 study assessed the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of linifanib in Japanese patients with advanced solid tumors.

    Hajime Asahina, Yosuke Tamura, Hiroshi Nokihara in Cancer Chemotherapy and Pharmacology (2012)

  19. Article

    Open Access

    Phase I study for ridaforolimus, an oral mTOR inhibitor, in Japanese patients with advanced solid tumors

    Ridaforolimus is a non-prodrug mTOR inhibitor. The safety, pharmacokinetics (PK), and antitumor activity of oral ridaforolimus were assessed in Japanese patients with refractory solid tumors.

    Yoshitaka Seki, Noboru Yamamoto, Yosuke Tamura in Cancer Chemotherapy and Pharmacology (2012)

  20. No Access

    Article

    Pharmacokinetic and pharmacodynamic study on amrubicin and amrubicinol in Japanese patients with lung cancer

    The pharmacokinetic (PK)–pharmacodynamic (PD) relationship of amrubicin and its active metabolite, amrubicinol, has only been evaluated using trough levels of these agents since the full PK profiles not yet be...

    Yoshinori Makino, Noboru Yamamoto, Hitoshi Sato in Cancer Chemotherapy and Pharmacology (2012)

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