Clinical Trials Sessions

Clinical Trials of Agents Directed Towards PI3K and Metabolic Pathways

Sunday, April 1, 2012
3:15 p.m. - 5:25 p.m.
Room W183, McCormick Place West

Chairperson:  Carlos L. Arteaga, Vanderbilt-Ingram Cancer Center, Nashville, TN

• BYL719, a next generation PI3K alpha specific inhibitor: Preliminary safety, pharmacokinetics and efficacy results from the first-in-human study
  Dejan Juric, Massachusetts General Hospital Cancer Center, Boston, MA
  Discussant: Lillian L. Siu, University Health Network Ontario Cancer Institute, Toronto, Ontario, Canada   
• A phase I, open label, dose escalation study of oral mammalian target of rapamycin inhibitor INK128 administered by intermittent dosing regimens in patients with advanced malignancies
  Josep Tabernero, Vall d’Hebron Institute of Oncology, Barcelona, Spain
  Discussant: Fabrice Andre, Institut Gustave Roussy, Villejuif, France
• Aberrations in translational regulation are associated with poor prognosis in hormone receptor-positive breast cancer
  Funda Meric-Bernstam, UT MD Anderson Cancer Center, Houston, TX
  Discussant: Carlos L. Arteaga, Vanderbilt-Ingram Cancer Center, Nashville, TN
• A phase II study of neoadjuvant metformin in prostatic carcinoma
  Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada
  Discussant:  Howard I. Scher, Memorial Sloan-Kettering Cancer Center, New York, NY

Late-Breaking Clinical Trials

Monday, April 2, 2012
10:30 a.m. - 12:30 p.m.
Room W192, McCormick Place West

Chairperson:  Malcolm J. Moore, University of Toronto University Health Network, Toronto, Canada

• Randomized phase II study of the efficacy and safety of gemcitabine + TH-302 (G+T) vs gemcitabine (G) alone in previously untreated patients with advanced pancreatic cancer
  M. J. Borad, Mayo Clinic Cancer Center – Arizona, Scottsdale, AZ
  Discussant: Malcolm J. Moore, University of Toronto University Health Network, Toronto, Canada
• A phase I dose escalation study of NVP-BGJ398, a selective pan FGFR inhibitor in genetically preselected advanced solid tumors
  Jurgen Wolf, Uniklinikum Koln, Koln, Germany
  Discussant: David B. Solit, Memorial Sloan-Kettering Cancer Center, New York, NY
• Analyses of anti-cancer testis antigen antibodies in glioma patients treated with Delta-24 oncolytic adenovirus
  Juan Fueyo, UT MD Anderson Cancer Center, Houston, TX
  Discussant: Cassian Yee, Fred Hutchinson Cancer Research Center, Seattle, WA
• Insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with refractory Ewing’s sarcoma family tumors
  Aung Naing, UT MD Anderson Cancer Center, Houston, TX
  Discussant: Lee J. Helman, National Cancer Institute, Bethesda, MD

Clinical Trials of Novel Agents

Monday, April 2, 2012
3:00 p.m. - 5:10 p.m.
Room W183, McCormick Place West

Chairperson:  Johann S. De Bono, Institute of Cancer Research, Sutton, United Kingdom  

• A phase II trial of selumetinib in women with recurrent low-grade serous carcinoma of the ovary or peritoneum
  John H. Farley, St. Joseph's Hospital and Medical Center, a member of Catholic Healthcare West, Phoenix, AZ
  Discussant: Gordon B. Mills, UT MD Anderson Cancer Center, Houston, TX
• The combination of bortezomib and decitabine: A phase I trial in patients with acute myeloid leukemia targeting FLT3 expression
  Sebastian Schwind, Ohio State University Comprehensive Cancer Center, Columbus, OH
  Discussant: Stephen D. Nimer, Memorial Sloan-Kettering Cancer Center, New York, NY
• Interim results from a randomized phase I-II first-in-human study of PK/PD guided escalating doses of SGI-110, a novel subcutaneous second generation hypomethylating agent in relapsed/refractory MDS and AML
  Jean Pierre Issa, Fels Institute, Temple University, Philadelphia, PA
  Discussant: Ross L. Levine, Memorial Sloan-Kettering Cancer Center, New York, NY
• A phase I study of MEHD7945A (MEHD), a first-in-class EGFR/HER3 dual action antibody, in patients with locally advanced or metastatic epithelial tumors
  Dejan Juric, Massachusetts General Hospital Cancer Center, Boston, MA
  Discussant: Pasi A. Jänne, Dana-Farber Cancer Institute, Boston, MA  

Clinical Trials of Agents for the Treatment of Prostate and Genitourinary Cancers

Tuesday, April 3, 2012
3:00 p.m. - 5:10 p.m.
Room W183 B/C, McCormick Place West

Chairperson:   William G. Nelson, Johns Hopkins Kimmel Comprehensive Cancer Center, Baltimore, MD   

• ARMOR1: Safety of galeterone (TOK-001) in a phase I clinical trial in chemotherapy naïve patients with castration resistant prostate cancer (CRPC)
  Mary-Ellen Taplin, Dana-Farber Cancer Institute, Boston, MA
  Discussant: Johann S. De Bono, Institute of Cancer Research, Sutton, United Kingdom 
• Biomarker analysis and final results of INT70/09 phase II proof-of-concept study of Pazopanib (PZP) in refractory urothelial cancer.
  Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
  Discussant: Kenneth J. Pienta, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
• Baseline serum adrenal androgens are prognostic and predictive of overall survival (OS) in patients with metastatic castrate-resistant prostate cancer (mCRPC): Results of the COU-AA-301 phase III randomized trial
  Charles Ryan, University of California-San Francisco, San Francisco, CA
  Discussant: William G. Nelson, Johns Hopkins Kimmel Comprehensive Cancer Center, Baltimore, MD
• Double-blind randomized clinical trial of vitamin D3 showing effects on tissue calcitriol levels, gene expression and proliferation immunohistochemistry in prostate cancer
  Reinhold Vieth, University of Toronto/Mount Sinai Hospital, Toronto, Ontario, Canada
  Discussant: Donald L. Trump, Roswell Park Cancer Institute, Buffalo, NY