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Last Updated: 04/25/2012

Phase 0 Trials in Oncologic Drug Development

September 5, 2007
Natcher Conference Center, NIH
Bethesda, MD

Title/Presenter Video Power Point
Dr. James H. Doroshow, NCI
The Exploratory IND Guidance
Dr. David Jacobson-Kram, FDA
Phase 0 Therapeutics Examples: Preclinical and Clinical Presentations
Dr. Joseph Tomaszewski, NCI
Dr. Shivaani Kummar, NCI
Herceptin as a Phase 0 Imaging Example
Dr. Steven Larson, Memorial Sloan-Kettering Cancer Institute
Panel: Clinical Trial Design/Biostatistics/Ethics/Recruitment
Phase 0 Trial Designs: How Do They Differ from First-in-Human Phase I Trials
Dr. Anthony Murgo, NCI, Moderator
Dr. Larry Rubinstein, NCI
Phase 0 Trials: Ethical Considerations
Dr. Holly Taylor, Berman Bioethics Institute
Dr. David Wendler, NIH
Phase 0 Trials from the Patient Side of the Desk
Ms. Deborah Collyar, Patient Advocates in Research (PAIR)
Recruitment Experience in a Phase 0 Trial of ABT-888 in Patients with Advanced Malignancies
Dr. Martin Gutierrez, NCI
Panel: Small Molecule Pharmacodynamics (PD) and Imaging —Models and Assay Development
Building Blocks of the DCTD Program in Clinical PD
Dr. Ralph Parchment, SAIC, Moderator
Optimizing Tissue Collection for PD Assays Using Non-Clinical Models
Dr. Melinda Hollingshead, NCI
Development of Assays for Use in Patient Response Measurement in Phase 0 Trials
Dr. Robert Kinders, SAIC
Phase 0 Trials—Why Haven’t They Been Widely Adopted?
Dr. Susan Galbraith, Bristol-Myers Squibb Company
Imaging to Guide Early Drug Trials
Dr. David Mankoff, University of Washington
Panel: Regulatory Issues in Phase 0 Imaging
Dr. Jerry Collins, NCI, Moderator
Nuts and Bolts—You Too Can Prepare an IND
Dr. Paula Jacobs, SAIC-Frederick, NCI
The Radioactive Drug Research Committee Approval Process for Tracer Use
Dr. Anthony Shields, Karmanos Cancer Institute
From Regulations to Reality: Obtaining and Holding an IND at Your Institution
Dr. Karen Kurdziel, Virginia Commonwealth University, NCI
Think Tank, Moderated Discussion
Dr. Joseph Tomaszewski, NCI, Moderator
Pharmacodynamic Paradigms in Early-Phase Cancer Clinical Trials
Dr. Hilary Calvert, Newcastle University, UK
Closing Summary
Dr. James H. Doroshow, NCI