PPT-MM-005: A Phase 1, Multicenter, Open-Label, Dose-Escalation Study

to Determine the Maximum Tolerated Dose for the Combination of Pomalidomide Bortezomib and Low Dose Dexamethasone in Patients with Relapsed or RelapsedRefractory Multiple Myeloma Richardson PG et . An overview of ADME Studies . Dale E. Sharp, PhD, DABT. Boehringer Ingelheim Pharmaceuticals Inc.. . Presentation Objectives. Give . an overview of the types and objectives of ADME studies with an emphasis on practical aspects of their conduct and interpretation. An overview of ADME Studies . Dale E. Sharp, PhD, DABT. Boehringer Ingelheim Pharmaceuticals Inc.. . Presentation Objectives. Give . an overview of the types and objectives of ADME studies with an emphasis on practical aspects of their conduct and interpretation. oncology. Shu-Fang Hsu Schmitz. University of Bern, Bern, Switzerland . Phase I trials . First in human. Ever first in human, or for a specific indication, or for a specific combination . treatment, or for a specific dosing schedule. Frédéric Triebel, M.D., PhD. , Prima Biomed Ltd. Three groups of patients responding to anti-PD-1 . (IFN-.  signature). A- Inflamed responders – respond to anti-PD-1. B- Inflamed non-responders (some infiltrates in the tumor margins but no response). (aka---how to know where to look and who to call). GIST. Rare disease, 5000-7000 new cases of GIST every year . Compare 230,000 new invasive breast CA cases/year. GIST studies tend to be opened at fewer sites . * Liver biopsy or . Fibroscan. ≤. 12.5 . kPa. or . Fibrosure. ®. . <. 0.48 + APRI . ≤ 1. Objective. Primary endpoint: SVR. 12 . (HCV RNA < 15 IU/mL), full analysis set ≥ 1 dose of study drug. Colorado School of Public Health. January 30. th. , 2013. Table of Contents. Orientation. Introduction. Components of a Phase I Trial. Phase I Trial Designs. Rule-Based Designs. Statistical Designs. References. Phase I Study of Olaparib and Temozolomide, in patients with recurrent and/or metastatic Ewing sarcoma : An Interim Update Edwin Choy, Gregory Cote, James Butrynski, David Harmon, Suzanne George, Andrew Wagner, Jeffrey Morgan, David D’Adamo, George Demetri . Krauss GL, Perucca E, Ben-Menachem E, Kwan P, Shih JJ, Squillacote D, Yang H, Gee M, Zhu J, Laurenza A. Perampanel, a selective, non-competitive AMPA receptor antagonist, as adjunctive therapy for refractory partial-onset seizures: interim results from Phase III, extension study 307. Myeloma. 1. Safety and Efficacy of Daratumumab with Lenalidomide and Dexamethasone in Relapsed or Relapsed, Refractory Multiple . Myeloma. 2. 1 . Martin TG et al.. Proc. ASH . 2014;Abstract 83.. 2 . Ublituximab. , a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (. mAb. ), in Patients with Relapsing Forms of Multiple Sclerosis (RMS). Novel Glycoengineered Anti-CD20 . mAb. Unique protein sequence. Crizotinib. (. cMET. inhibitor) Combined . with . Binimetinib. (MEK1/2 inhibitor) in Patients with Advanced Solid Tumours. Wilson RH. 1,2. , Hari . Dass. P. 10. , Van Schaeybroeck S. 1,2. , . Rolfo. J. Bennouna. 1. , A. Sibille. 2. , C. Debruyne. 3. , B. Colinet. 4. , I. Demedts. 5. , S. Derijcke. 6. , L. Greillier. 7. , J. Jurgens. 8. , H. Lena. 9. , D. Moro-Sibilot. 10. , M. Pérol. 11. , X. Quantin. C. areers . and. A. cademic. L. iaison . C. ommittee . Inspiring school students to study statistics at our event,. “Maths meets Medicine”. An enthusiastic group of volunteers from a range of companies from across the industry.