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  1. Article

    Open Access

    Phase 1 cohort expansion study of LY3023414, a dual PI3K/mTOR inhibitor, in patients with advanced mesothelioma

    BACKGROUND LY3023414 is a selective, ATP competitive inhibitor of class I PI3K isoforms, mTORC1/2 and DNA-PK. A Phase 1 dose escalation, 200 mg twice daily (BID) of LY3023414 was the determined recommended phase ...

    Marjorie G. Zauderer, Evan W. Alley, Johanna Bendell… in Investigational New Drugs (2021)

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  2. No Access

    Article

    Immunologic and tumor responses of pegilodecakin with 5-FU/LV and oxaliplatin (FOLFOX) in pancreatic ductal adenocarcinoma (PDAC)

    Background Treatment options for pancreatic ductal adenocarcinoma (PDAC) are limited and checkpoint blockade inhibitors have been disappointing in this disease. Pegilodecakin has demonstrated single agent anti-tu...

    J. Randolph Hecht, Kyriakos P. Papadopoulos… in Investigational New Drugs (2021)

  3. No Access

    Article

    Phase Ib study of the MEK inhibitor cobimetinib (GDC-0973) in combination with the PI3K inhibitor pictilisib (GDC-0941) in patients with advanced solid tumors

    Purpose We investigated the combination of the MEK inhibitor, cobimetinib, and the pan-PI3K inhibitor, pictilisib, in an open-label, phase Ib study. Experimental Design Patients with advanced solid tumors were en...

    Geoffrey I. Shapiro, Patricia LoRusso, Eunice Kwak… in Investigational New Drugs (2020)

  4. No Access

    Article

    Ruxolitinib + capecitabine in advanced/metastatic pancreatic cancer after disease progression/intolerance to first-line therapy: JANUS 1 and 2 randomized phase III studies

    Background Ruxolitinib, a Janus kinase 1 (JAK1)/JAK2 inhibitor, plus capecitabine improved overall survival (OS) vs capecitabine in a subgroup analysis of patients with metastatic pancreatic cancer and systemic i...

    Herbert Hurwitz, Eric Van Cutsem, Johanna Bendell… in Investigational New Drugs (2018)

  5. No Access

    Article

    A phase II study of antibody-drug conjugate, TAK-264 (MLN0264) in previously treated patients with advanced or metastatic pancreatic adenocarcinoma expressing guanylyl cyclase C

    Background This phase II open-label, multicenter study evaluated the efficacy, safety, and tolerability of TAK-264 in previously treated patients with advanced or metastatic pancreatic adenocarci...

    Khaldoun Almhanna, David Wright, Teresa Macarulla Mercade… in Investigational New Drugs (2017)

  6. No Access

    Article

    Phase II study of the antibody-drug conjugate TAK-264 (MLN0264) in patients with metastatic or recurrent adenocarcinoma of the stomach or gastroesophageal junction expressing guanylyl cyclase C

    Background The first-in-class antibody–drug conjugate TAK-264 (formerly MLN0264) consists of an antibody targeting guanylyl cyclase C (GCC) conjugated to monomethyl auristatin E (MMAE) vi...

    Khaldoun Almhanna, Maria Luisa Limon Miron, David Wright… in Investigational New Drugs (2017)

  7. No Access

    Article

    Phase 1b study of the oral gemcitabine ‘Pro-drug’ LY2334737 in combination with capecitabine in patients with advanced solid tumors

    Background This Phase 1b study aimed to determine the recommended Phase 2 dose of LY2334737, an oral pro-drug of gemcitabine, in combination with capecitabine, an oral pro-drug of 5-fluorouracil,...

    Jeffrey R. Infante, Karim A. Benhadji, Grace K. Dy… in Investigational New Drugs (2015)