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 aboratory 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 #
3P30CA023100-27S6
Application #
8468780
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
2014-04-30
Budget Start
2011-05-01
Budget End
2013-04-30
Support Year
27
Fiscal Year
2012
Total Cost
$105,999
Indirect Cost
$36,302
Name
University of California San Diego
Department
Type
DUNS #
804355790
City
La Jolla
State
CA
Country
United States
Zip Code
92093
Connor, Michael; Karunamuni, Roshan; McDonald, Carrie et al. (2017) Regional susceptibility to dose-dependent white matter damage after brain radiotherapy. Radiother Oncol 123:209-217
Ly, Peter; Teitz, Levi S; Kim, Dong H et al. (2017) Selective Y centromere inactivation triggers chromosome shattering in micronuclei and repair by non-homologous end joining. Nat Cell Biol 19:68-75
Sundaramoorthy, Sriramkumar; Garcia Badaracco, Adrian; Hirsch, Sophia M et al. (2017) Low Efficiency Upconversion Nanoparticles for High-Resolution Coalignment of Near-Infrared and Visible Light Paths on a Light Microscope. ACS Appl Mater Interfaces 9:7929-7940
D'Antonio, Matteo; Woodruff, Grace; Nathanson, Jason L et al. (2017) High-Throughput and Cost-Effective Characterization of Induced Pluripotent Stem Cells. Stem Cell Reports 8:1101-1111
Guo, Shicheng; Diep, Dinh; Plongthongkum, Nongluk et al. (2017) Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet 49:635-642
Jiang, Qingfei; Crews, Leslie A; Holm, Frida et al. (2017) RNA editing-dependent epitranscriptome diversity in cancer stem cells. Nat Rev Cancer 17:381-392
Martínez, María Elena; Gomez, Scarlett L; Tao, Li et al. (2017) Contribution of clinical and socioeconomic factors to differences in breast cancer subtype and mortality between Hispanic and non-Hispanic white women. Breast Cancer Res Treat 166:185-193
Krishnan, A P; Karunamuni, R; Leyden, K M et al. (2017) Restriction Spectrum Imaging Improves Risk Stratification in Patients with Glioblastoma. AJNR Am J Neuroradiol 38:882-889
Connor, Michael J; Marshall, Deborah C; Moiseenko, Vitali et al. (2017) Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015. Int J Radiat Oncol Biol Phys 97:18-26
Panopoulos, Athanasia D; D'Antonio, Matteo; Benaglio, Paola et al. (2017) iPSCORE: A Resource of 222 iPSC Lines Enabling Functional Characterization of Genetic Variation across a Variety of Cell Types. Stem Cell Reports 8:1086-1100

Showing the most recent 10 out of 805 publications