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Safety, tolerability, and pharmacokinetic profile of dabrafenib in Japanese patients with BRAF V600 mutation-positive solid tumors: a phase 1 study

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  1. Article

    Open Access

    Pooled Analysis of Studies Evaluating Fosnetupitant and Risk Factors for Cisplatin-Induced Nausea and Vomiting During the Extended Overall Phase

    Fosnetupitant is a novel neurokinin 1 receptor antagonist (NK1RA) with favorable antiemetic efficacy in patients receiving emetogenic chemotherapy. This study assessed the efficacy of fosnetupitant in combination...

    Naoki Inui, Yukihiro Toi, Yasuto Yoneshima, Masahiro Morise in Advances in Therapy (2023)

  2. Article

    Open Access

    Findings of virtual bronchoscopic navigation can predict the diagnostic rate of primary lung cancer by bronchoscopy in patients with peripheral lung lesions

    Despite being minimally invasive, bronchoscopy does not always result in pathological specimens being obtained. Therefore, we investigated whether virtual bronchoscopic navigation (VBN) findings were associate...

    Atsushi Kitamura, Yutaka Tomishima, Ryosuke Imai, Naoki Nishimura in BMC Pulmonary Medicine (2022)

  3. Article

    Open Access

    Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blind, Phase 3 Study (CONSOLE)

    We describe the results of an exploratory analysis performed on the first head-to-head study (JapicCTI-194611) comparing two different intravenous (IV) neurokinin 1 (NK1) receptor antagonists, fosnetupitant and f...

    Akito Hata, Yoshimasa Shiraishi, Naoki Inui, Morihito Okada in Oncology and Therapy (2022)

  4. Article

    Open Access

    Phase I study of TAS-121, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with non-small-cell lung cancer harboring EGFR mutations

    Purpose We investigated the safety, tolerability, pharmacokinetics, and efficacy of TAS-121, a novel, potent, and highly selective third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR...

    Makoto Nishio, Haruyasu Murakami, Yuichiro Ohe, Toyoaki Hida in Investigational New Drugs (2019)

  5. 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)

  6. Article

    Open Access

    Phase I study of Nivolumab, an anti-PD-1 antibody, in patients with malignant solid tumors

    Background This study evaluated the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of single and multiple doses of nivolumab in Japanese patients with malig...

    Noboru Yamamoto, Hiroshi Nokihara, Yasuhide Yamada in Investigational New Drugs (2017)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. Article

    Open Access

    Phase I study of ipilimumab in phased combination with paclitaxel and carboplatin in Japanese patients with non-small-cell lung cancer

    Background Ipilimumab is an antibody that targets the cytotoxic T-lymphocyte antigen-4 to potentiate an antitumor response. Adding ipilimumab 10 mg/kg to paclitaxel (PTX) and carboplatin ...

    Hidehito Horinouchi, Noboru Yamamoto, Yutaka Fujiwara in Investigational New Drugs (2015)

  12. 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)

  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. Article

    Erratum to: Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naïve patients with advanced nonsquamous non-small-cell lung cancer

    The original version of this article unfortunately contains some errors in the text describing the incidences of toxicities. The correct text is given below:

    Isamu Okamoto, Keisuke Aoe, Terufumi Kato, Yukio Hosomi in Investigational New Drugs (2013)

  15. Article

    Erratum to: Safety and tolerability of AZD8055 in Japanese patients with advanced solid tumors; a dose-finding phase I study

    Hajime Asahina, Hiroshi Nokihara, Noboru Yamamoto in Investigational New Drugs (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

    Figitumumab combined with carboplatin and paclitaxel in treatment-naïve Japanese patients with advanced non-small cell lung cancer

    Objectives The insulin-like growth factor (IGF) signaling pathway has been implicated in the pathogenesis of numerous tumor types, including non-small cell lung cancer (NSCLC). Figitumuma...

    Yasushi Goto, Ikuo Sekine, Maki Tanioka, Takashi Shibata in Investigational New Drugs (2012)

  19. 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)

  20. 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)

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