INTRODUCTION Definitive testing of the value of novel therapeutics and diagnostics in large randomized trials requires the prior execution of 'early phase' trials that provide the information needed to design pivotal studies. Phase 1 trials are directed at determining doses of drug that are appropriate for subsequent trials and the pattern of adverse events produced. Feasibility and pilot trials are conducted to obtain preliminary information on the tolerability of particular drug combinations, the ability to measure effects on drug targets, or to assess whether a particular biomarker or imaging technology can assist in predicting or assessing response. Studies directed at defining the pharmacokinetics (PK) of a drug, or its effect on specific target cells (pharmacodynamics, PD), are often included as components of Phase 1 or feasibility trials, but are sometimes executed as stand-alone studies. These types of trials are referred to as 'early phase' trials and they have an essential role in the successful development and regulatory approval of novel therapeutics and diagnostics. These trials are challenging to perform and often require personnel with substantial pharmacology and research laboratory experience in addition to the skills of a clinical investigator. The rate at which novel therapeutics can proceed through early phase trials is the gating factor that determines how quickly the larger scale Phase 2 and Phase 3 trials that are required to demonstrate efficacy compared to standard therapy can be initiated. Improving the efficiency of these early phase trials is one of the goals of the FDA's 'critical pathway' initiative and is a major focus of the clinical trials program of the Moores Cancer Center. We believe that it is appropriate to commit the resources of the Protocol Specific Research component of the CCSG application to this effort.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA023100-26
Application #
8096642
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2010-05-01
Budget End
2011-04-30
Support Year
26
Fiscal Year
2010
Total Cost
$448,828
Indirect Cost
Name
University of California San Diego
Department
Type
DUNS #
804355790
City
La Jolla
State
CA
Country
United States
Zip Code
92093
Huang, Justin K; Carlin, Daniel E; Yu, Michael Ku et al. (2018) Systematic Evaluation of Molecular Networks for Discovery of Disease Genes. Cell Syst 6:484-495.e5
Kalyanaraman, Hema; Schwaerzer, Gerburg; Ramdani, Ghania et al. (2018) Protein Kinase G Activation Reverses Oxidative Stress and Restores Osteoblast Function and Bone Formation in Male Mice With Type 1 Diabetes. Diabetes 67:607-623
Hartman, Sheri J; Marinac, Catherine R; Cadmus-Bertram, Lisa et al. (2018) Sedentary Behaviors and Biomarkers Among Breast Cancer Survivors. J Phys Act Health 15:1-6
Wu, Yan; Tamayo, Pablo; Zhang, Kun (2018) Visualizing and Interpreting Single-Cell Gene Expression Datasets with Similarity Weighted Nonnegative Embedding. Cell Syst 7:656-666.e4
Dow, Michelle; Pyke, Rachel M; Tsui, Brian Y et al. (2018) Integrative genomic analysis of mouse and human hepatocellular carcinoma. Proc Natl Acad Sci U S A 115:E9879-E9888
Que, Xuchu; Hung, Ming-Yow; Yeang, Calvin et al. (2018) Oxidized phospholipids are proinflammatory and proatherogenic in hypercholesterolaemic mice. Nature 558:301-306
Murzin, Vyacheslav L; Woods, Kaley; Moiseenko, Vitali et al. (2018) 4? plan optimization for cortical-sparing brain radiotherapy. Radiother Oncol 127:128-135
Norton, Jeffrey A; Kim, Teresa; Kim, Joseph et al. (2018) SSAT State-of-the-Art Conference: Current Surgical Management of Gastric Tumors. J Gastrointest Surg 22:32-42
Ikeda, Sadakatsu; Tsigelny, Igor F; Skjevik, Åge A et al. (2018) Next-Generation Sequencing of Circulating Tumor DNA Reveals Frequent Alterations in Advanced Hepatocellular Carcinoma. Oncologist 23:586-593
Buckley, Alexandra R; Ideker, Trey; Carter, Hannah et al. (2018) Exome-wide analysis of bi-allelic alterations identifies a Lynch phenotype in The Cancer Genome Atlas. Genome Med 10:69

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