课题基金 / 基金详情

Phase 2 Clinical Trials Program for Experimental Therapeutics Clinical Trials Network

Phase 2 Clinical Trials Program for Experimental Therapeutics Clinical Trials Network
实验疗法临床试验网络二期临床试验计划
批准号:
9094959
负责人:
ALEX A. ADJEI
金额:
$91.25万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2014
资助国家:
美国
项目状态:
已结题
起止时间:
2014-04-07 至 2020-02-29
关键词:
AdoptionAfrican AmericanAngiographyAntineoplastic AgentsBiologicalBiological MarkersBiopsyBlood flowBrain NeoplasmsCLIA certifiedCancer BiologyCancer CenterCancer PatientClinicClinicalClinical TrialsClinical Trials NetworkCombined Modality TherapyCommunitiesComprehensive Cancer CenterDendritic CellsDiagnosisDoppler UltrasonographyDrug KineticsEffectivenessEligibility DeterminationEnrollmentFutureGenomicsGoalsGrantHerbert Irving Comprehensive Cancer CenterHispanic AmericansHolden Comprehensive Cancer Center at the University of IowaImageInvestigational TherapiesIowaLaboratoriesLaboratory StudyLymphomaMalignant NeoplasmsMarylandMayo Clinic Cancer CenterMeasuresMetabolicMindModalityMolecular ProfilingMolecular TargetNational Cancer InstituteNew AgentsNormal tissue morphologyOncolytic virusesOutcomeOvaryPancreasParentsPathologyPathway interactionsPatientsPeer ReviewPeptidesPerformancePeripheral Blood Mononuclear CellPharmacogeneticsPhasePhase II Clinical TrialsPhase III Clinical TrialsPhysiologic pulsePopulationPositron-Emission TomographyProtocols documentationReaction TimeRecording of previous eventsResearchSafetyScienceSiteSpecialized Program of Research ExcellenceTNFRSF5 geneTestingTherapeuticTherapeutic Clinical TrialTimeToxic effectTranslatingTranslational ResearchTumor TissueUniversitiesWorkcancer therapycancer typedesigndrug developmentexperiencemalignant breast neoplasmmembernovelnovel anticancer drugpatient populationpatient safetyphase 1 studyphase 2 studypotential biomarkerpre-clinicalprogramspublic health relevancesmall moleculesuccesstargeted agenttherapeutic evaluationtumor

项目摘要

项目成果

ALEX A. ADJEI的其他基金

相似基金

相关文献

中文摘要
翻译

英文摘要
 DESCRIPTION (provided by applicant): This proposed UM1 phase 2 supplement brings together teams from NCI-designated comprehensive cancer centers at Mayo Clinic, University of Maryland, Columbia University, and the University of Iowa to collectively perform early phase clinical trials. Members of this proposed ETCTN team have accrued 3939 patients to phase 2 clinical trials from 2010 through 2014, demonstrated expertise in translational science, and established specialized facilities to develop biomarkers for clinical trials, including the Mayo Clinic Pathology Research Core and CLIA-certified University of Maryland Translational Genomic Laboratory. We now propose to conduct phase 2 clinical trials of NCI-sponsored anti-cancer agents to evaluate the clinical activity and biological impact of these agents on their molecular targets, elucidate other relevant biologic effects, and determine the correlation between clinical outcomes and relevant biomarkers and/or imaging endpoints. The goal of these studies is to not only determine, as efficiently as is compatible with patient safety, the effectiveness of new anticancer agents selected by the NCI or promising combination therapies and high- priority agents that are pivotal for drug development, but also facilitate the correlativ science needed to understand and properly develop these agents. The intent is to seamlessly move studies from phase 1 into phase 2 and to bring forward therapeutic approaches that can be incorporated into phase 3 clinical trials sponsored by other mechanisms. Studies will be designed using clinical endpoints that are appropriate for the therapeutic mechanism of the specific agent under study such as response, time to progression, progression- free rate at a point in time or survival. Importantly, alternative or secondary endpoints for the studies to be performed under this supplement may include changes in biomarker endpoints or imaging endpoints, including changes in blood flow and/or alterations in tumor metabolic activity. Accordingly, the specific aims of this proposal are to: i) determine the clinical activity, efficac and safety of novel anticancer agents and combinations selected by NCI for evaluation of therapeutic activity across a range of malignancies, whether chosen by histological subtype or molecular profile; ii) efficiently and seamlessly take promising therapies from phase 1 into phase 2 trials; iii) evaluate translational endpoints such as levels of expression and/or activity of molecular targets and/or downstream effectors pertinent to a given agent or pathway modulated by the agent under study; iv) identify and test potential biomarkers (with particular emphasis where possible on genomics and imaging) that may serve as predictors of efficacy or toxicity; and v) translate preclinical science and new discoveries from R01, SPORE or other peer reviewed mechanisms into clinical trials that leverage the expertise of the scientific community using a team science approach.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Clinical evaluation of combination oncolytic viro-immunotherapy for solid tumors
  • 批准号:
    9815079
  • 项目类别:
  • 资助金额:
    $10.8万
  • 财政年份:
    2018
  • 负责人:
    ALEX A. ADJEI
  • 依托单位:
Network Lead Academic Participating Site Grant from the Roswell Cancer Inst.
NCI Experimental Therapeutics-Clinical Trials Network with Phase 1 Emphasis
  • 批准号:
    9086290
  • 项目类别:
  • 资助金额:
    $71.82万
  • 财政年份:
    2014
  • 负责人:
    ALEX A. ADJEI
  • 依托单位:
Data & Safety Monitoring
海外基金