EARLY PHASE CLINICAL RESEARCH SUPPORT (Core-030) ABSTRACT The Early Phase Clinical Research Support (EPCRS) component provides data management support to conduct novel early-phase clinical trials designed from research findings of UCCC members. The overall objective of the EPCRS is to promote innovative clinical trials in the UCCC catchment area (the State of Colorado), to facilitate inter- and intra-programmatic translational collaboration within UCCC, and to support the development of novel cutting-edge therapies and strategies to prevent and treat cancer. These clinical trials are hypothesis-driven, high-priority, innovative, Pilot (feasibility) or Phase 0/I institutional trials focused on early phase testing of an agent or device for the diagnosis, prevention, detection or treatment of cancer. Expected outcomes include subsequent later stage clinical testing through the National Clinical Trials Network (NCTN), the Phase II mechanism of the Experimental Therapeutics Clinical Trials Network (ET-CTN), or in conjunction with independent peer-reviewed grant support or industry funding. Although EPCRS was not funded over the last cycle due to disapproval of our PRMS, UCCC has continued to conduct early phase trials which adhere to the NCI eligibility requirements of this mechanism and through our NCI UM1 Southwest Early Clinical Trials (SECT) Consortium (UM1CA186688) with MD Anderson Cancer Center, as well as institutional and industry support, funding has been available to translate bench observations made by our translational UCCC members, to the bedside. Going forward a number of changes have been instituted to further ensure that only the highest quality early clinical science is carried out at UCCC. These include an Investigator-Initiated Trial (IIT) structure, that includes an IIT Incubator (IIT-I) meeting chaired by Eckhardt that brings together a multidisciplinary group of investigators to discuss and promote hypothesis-driven early trials, as well as an IIT Review Committee (IIT-RC) chaired by Flaig and Eckhardt that is charged with ensuring that all components of a concept such as the scientific rationale, statistics, data management, budgeting and finance are assembled to enhance feasibility and to enable prioritization for funding decisions. In addition to the requested CCSG funds, UCCC will provide $250K/yr for early-phase clinical trials that will facilitate expansion of IITs and provide greater opportunity for the translational science of UCCC programs to impact patients in our catchment area. Our future directions include: 1) Establishing processes that stimulate direct collaborations between the UCCC clinical disease groups and the UCCC Research Programs; 2) Working with preclinical scientists in the UCCC to enable the development of novel animal models that can be used provide the rationale for hypothesis-driven early clinical trials; 3) Evaluating challenges regarding participation among racial/ethnic and socioeconomically underserved populations in early clinical trials; 4) Interacting with major UCCC wide strategic initiatives that involve early clinical investigation.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
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Subcommittee I - Transistion to Independence (NCI)
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University of Colorado Denver
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Harder, Bryan; Tian, Wang; La Clair, James J et al. (2017) Brusatol overcomes chemoresistance through inhibition of protein translation. Mol Carcinog 56:1493-1500
Chen, Yufei; Anastassiadis, Konstantinos; Kranz, Andrea et al. (2017) MLL2, Not MLL1, Plays a Major Role in Sustaining MLL-Rearranged Acute Myeloid Leukemia. Cancer Cell 31:755-770.e6
DeRyckere, Deborah; Lee-Sherick, Alisa B; Huey, Madeline G et al. (2017) UNC2025, a MERTK Small-Molecule Inhibitor, Is Therapeutically Effective Alone and in Combination with Methotrexate in Leukemia Models. Clin Cancer Res 23:1481-1492
Scarborough, Hannah A; Helfrich, Barbara A; Casás-Selves, Matias et al. (2017) AZ1366: An Inhibitor of Tankyrase and the Canonical Wnt Pathway that Limits the Persistence of Non-Small Cell Lung Cancer Cells Following EGFR Inhibition. Clin Cancer Res 23:1531-1541
Neelakantan, Deepika; Zhou, Hengbo; Oliphant, Michael U J et al. (2017) EMT cells increase breast cancer metastasis via paracrine GLI activation in neighbouring tumour cells. Nat Commun 8:15773
Barón, Anna E; Kako, Severine; Feser, William J et al. (2017) Clinical Utility of Chromosomal Aneusomy in Individuals at High Risk of Lung Cancer. J Thorac Oncol 12:1512-1523
Todd, Maria C; Langan, Thomas A; Sclafani, Robert A (2017) Doxycycline-Regulated p16MTS1 Expression Suppresses the Anchorage-Independence and Tumorigenicity of Breast Cancer Cell Lines that Lack Endogenous p16. J Cancer 8:190-198
Brown, Dustin G; Borresen, Erica C; Brown, Regina J et al. (2017) Heat-stabilised rice bran consumption by colorectal cancer survivors modulates stool metabolite profiles and metabolic networks: a randomised controlled trial. Br J Nutr 117:1244-1256
Haverkos, Bradley M; Abbott, Diana; Hamadani, Mehdi et al. (2017) PD-1 blockade for relapsed lymphoma post-allogeneic hematopoietic cell transplant: high response rate but frequent GVHD. Blood 130:221-228
Shearn, Colin T; Saba, Laura M; Roede, James R et al. (2017) Differential carbonylation of proteins in end-stage human fatty and nonfatty NASH. Free Radic Biol Med 113:280-290

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