MU Department of Medicine 2011-2013 Annual Report Feb. 2014

2011-2013 Hematology/medical oncology Donald Doll, MD Investigator An Open-Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin Administered In Combination with Rituximab Compared to Defined Investigator’s Choice Therapy In Subjects With Relapsed or Refractory CD22-Positive Aggressive NonHodgkin, Pfizer, $7,880, 03/03/1020 to 03/21/2018 Investigator A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients with First Relapsed or Refractory Acute Myeloid Leukemia (VALOR), Sunesis, $4,351, 06/09/2011 to 09/30/2015 Investigator Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG in Combination with Cetuximab (Erbitux) in Subjects with Recurrent or Progressive KRAS Wild Type Colorectal Cancer, Medpace, $22,511, 05/13/2011 to 05/12/2014 Principal Investigator A Registry of Sipuleucel-tTtherapy in Men with Advanced Prostate Cancer, United Biosource, $ 1,477, 06/07/2012 to 03/31/2016 Investigator APHINITY: a randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive breast cancer, Mayo Clinic, $3,572, 07/01/2012 to 06/30/2022 Investigator ACT IV: International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Department of Medicine 59 Diagnosed, Surgically Resected, Investigator EGFRvIII-positive Glioblastoma, A Randomized, Double Blind, Phase 3 Novella, $1,632, 09/01/2012 to Study of Docetaxel and Ramucirumab 08/31/2015 versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Carl Freter, MD, PhD Cell Lung Cancer Following Disease Principal Investigator Progression after One Prior Platinum Phase II Multicenter, Double-Blind, Based Therapy, Eli Lilly, $52,752, Randomized Trial Comparing 12/15/2010 to 02/15/2013 Anastrozole-Placebo to the Combination Anastrozole ZD-1839 Principal Investigator in Postmenopausal Patients with An Open-Label, Randomized, Phase Estrogen Receptor and/or Progesterone 3 Study of Inotuzumab Ozogamicin Receptor Metastatic Breast Cancer, Administered In Combination with AstraZeneca, $3,243, 01/05/2004 to Rituximab Compared to Defined 12/06/2012 Investigator’s Choice Therapy In Subjects With Relapsed or Refractory Principal Investigator CD22-Positive Aggressive Non- Phase 1/2 Trial of Oral Karenitecin in Hodgkin, Pfizer, $7,881, 03/03/2010 Patients with Solid Tumors and Patients to 03/31/2018 with Relapsed Non-Small Cell Lung Cancer (NSCLC), BioNumerik, $1,050, Principal Investigator 04/01/2004 to 04/03/2013 Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Principal Investigator Study of the Efficacy and Safety of Phase 2b Study of Sunitinib Plus Vosaroxin and Cytarabine Versus Oxaliplatin, 5-Fluorouracil and Placebo and Cytarabine in Patients Leucovorin Versus Bevacizumab Plus with First Relapsed or Refractory Acute FOLFOX as First Line Treatment In Myeloid Leukemia (VALOR), Sunesis, Patients with Metastatic Colorectal $4,351, 06/09/2011 to 09/30/2015 Cancer, Pfizer, $2,816, 10/08/2008 to 11/30/2011 Investigator A Phase 3 Open-Label, Randomized, Principal Investigator Multicenter Study of Imprime PGG A Randomized Discontinuation Study in Combination with Cetuximab of XL184 in Subjects with Advanced (Erbitux) in Subjects with Recurrent Solid Tumors, Exelixis, $3,026, or Progressive KRAS Wild Type 10/22/2009 to 10/21/2013 Colorectal Cancer, Medpace, $22,511, 05/13/2011 to 05/12-2014 Principal Investigator A184-095-069: Randomized, Double Investigator Blind, Phase 3 Trial to Compare the Columbia Hemophilia Treatment Efficacy of Ipilimumab vs Placebo Center, University of Texas Health in Asymptomatic or Minimally Science Center, $18,516, 07/01/2012 Symptomatic Patients with Metastatic to 06/30/2013 Chemotherapy-Naive Castration Resistant Prostate Cancer, Bristol Investigator Myers Squibb, $2,689, 08/18/2010 to Adu

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