Clinical Trials, Phase II as Topic

• 

  Subject Areas on Research

  • "Protocol for a phase 2, randomized, double-blind, placebo-controlled, safety and efficacy study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction": study protocol for a randomized controlled trial. 
  • 10 x '20 Progress--development of new drugs active against gram-negative bacilli: an update from the Infectious Diseases Society of America. 
  • A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials. 
  • A Rational Approach to Target the Epidermal Growth Factor Receptor in Glioblastoma. 
  • A design alternative for two-stage, phase II, multicenter cancer clinical trials. 
  • A genome-wide association study identifies susceptibility loci for ovarian cancer at 2q31 and 8q24. 
  • A hub for bench-to-bedside pharmacogenomic-based research. 
  • A murine lung cancer co-clinical trial identifies genetic modifiers of therapeutic response. 
  • A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease. 
  • A phase II trial for minimally invasive esophagectomy. 
  • A randomized Phase II trial evaluating efficacy, safety, and tolerability of oral BI 409306 in attenuated psychosis syndrome: Design and rationale. 
  • A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: design and rationale of the RADAR Phase IIb trial. 
  • A repeated measures model for analysis of continuous outcomes in sequential parallel comparison design studies. 
  • ALSUntangled No. 35: Hyperbaric Oxygen Therapy. 
  • Absence of the wild-type allele predicts poor prognosis in adult de novo acute myeloid leukemia with normal cytogenetics and the internal tandem duplication of FLT3: a cancer and leukemia group B study. 
  • Acute ischemic heart disease. 
  • Adaptive Global Innovative Learning Environment for Glioblastoma: GBM AGILE. 
  • Adaptive clinical trial design. 
  • Adaptive design methods in clinical trials - a review. 
  • Adjuvanting a subunit COVID-19 vaccine to induce protective immunity. 
  • Admissible two-stage designs for phase II cancer clinical trials. 
  • An intervention to improve cancer patients' understanding of early-phase clinical trials. 
  • Andexanet alfa for the reversal of Factor Xa inhibitor related anticoagulation. 
  • Antagonism of the Neonatal Fc Receptor as an Emerging Treatment for Myasthenia Gravis. 
  • Antigen-specific T-lymphocyte function after cord blood transplantation. 
  • Antiretroviral therapy: evaluating the new era in HIV treatment. 
  • Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn: protocol and statistical analysis plan. 
  • Application of a new multinomial phase II stopping rule using response and early progression. 
  • Association of the timing of ST-segment resolution with TIMI myocardial perfusion grade in acute myocardial infarction. 
  • Between-arm comparisons in randomized Phase II trials. 
  • Bevacizumab (Avastin®) in cancer treatment: A review of 15 years of clinical experience and future outlook. 
  • Bevacizumab combined with standard fluoropyrimidine-based chemotherapy regimens to treat colorectal cancer. 
  • Bevacizumab improves the overall and progression-free survival of patients with metastatic colorectal cancer treated with 5-fluorouracil-based regimens irrespective of baseline risk. 
  • Bevacizumab in the treatment of metastatic colorectal cancer: safety profile and management of adverse events. 
  • Bevacizumab-based therapies in the first-line treatment of metastatic colorectal cancer. 
  • Blinatumomab: A New Treatment for Adults With Relapsed Acute Lymphocytic Leukemia. 
  • CDX-1307: a novel vaccine under study as treatment for muscle-invasive bladder cancer. 
  • Cabozantinib in genitourinary malignancies. 
  • Can RECIST response predict success in phase 3 trials in men with metastatic castration-resistant prostate cancer? 
  • Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors' Expert Forum. 
  • Ceftaroline: a cephalosporin with expanded Gram-positive activity. 
  • Celecoxib With Neoadjuvant Chemotherapy for Breast Cancer Might Worsen Outcomes Differentially by COX-2 Expression and ER Status: Exploratory Analysis of the REMAGUS02 Trial. 
  • Chemotherapy and radiation of anal canal cancer: the first approach. 
  • Chemotherapy in malignant pleural mesothelioma. A review. 
  • Chemotherapy-related amenorrhea after adjuvant paclitaxel-trastuzumab (APT trial). 
  • Cholangiocarcinoma: Correlation between Molecular Profiling and Imaging Phenotypes. 
  • Circadian rhythms in cognitive functioning among patients with schizophrenia: impact on signal detection in clinical trials of potential pro-cognitive therapies. 
  • Circulating tumor cell analysis in metastatic triple-negative breast cancers. 
  • Clinical efficacy of taxane-trastuzumab combination regimens for HER-2-positive metastatic breast cancer. 
  • Combined assessment of thrombolysis in myocardial infarction flow grade, myocardial perfusion grade, and ST-segment resolution to evaluate epicardial and myocardial reperfusion. 
  • Comparable outcomes of patients eligible vs ineligible for SWOG leukemia studies. 
  • Comparing an experimental agent to a standard agent: relative merits of a one-arm or randomized two-arm Phase II design. 
  • Comparison of Cilta-cel, an Anti-BCMA CAR-T Cell Therapy, Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma. 
  • Concurrent chemoradiotherapy for unresectable stage III non-small cell lung cancer. 
  • Concurrent chemotherapy and intensity-modulated radiotherapy for organ preservation of locoregionally advanced oral cavity cancer. 
  • Consent forms and the therapeutic misconception: the example of gene transfer research. 
  • Cost implications of closure of atrial septal defect. 
  • Cytotoxic chemotherapy for pancreatic cancer: Advances to date and future directions. 
  • DNA methylation signatures reflect aging in patients with nonalcoholic steatohepatitis. 
  • Dabrafenib and Trametinib in Patients With Tumors With BRAFV600E Mutations: Results of the NCI-MATCH Trial Subprotocol H. 
  • Deep learning-based classification and segmentation of retinal cavitations on optical coherence tomography images of macular telangiectasia type 2. 
  • Design issues in randomized phase II/III trials. 
  • Designing effective drug and device development programs for hospitalized heart failure: a proposal for pretrial registries. 
  • Designing phase II studies in cancer with time-to-event endpoints. 
  • Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations. 
  • Designs for randomized phase II clinical trials with two treatment arms. 
  • Do patients participating in clinical trials want to know study results? 
  • Economic end points in phase II trials. 
  • Efficacy and safety of bevacizumab in metastatic colorectal cancer: pooled analysis from seven randomized controlled trials. 
  • Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. 
  • Epicardial delivery of XC001 gene therapy for refractory angina coronary treatment (The EXACT Trial): Rationale, design, and clinical considerations. 
  • Eptifibatide in percutaneous coronary intervention. A review. 
  • Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial. 
  • Evaluating treatment efficacy by multiple end points in phase II acute heart failure clinical trials: analyzing data using a global method. 
  • Evaluation and recommendations on good clinical laboratory practice guidelines for phase I-III clinical trials. 
  • Everolimus in colorectal cancer. 
  • Extending principles learned in model systems to clinical trials design. 
  • Fc Gamma Receptor Polymorphisms Modulated the Vaccine Effect on HIV-1 Risk in the HVTN 505 HIV Vaccine Trial. 
  • Finding the optimal combination therapy for the treatment of newly diagnosed AML in older patients unfit for intensive therapy. 
  • Floxuridine hepatic arterial infusion associated biliary toxicity is increased by concurrent administration of systemic bevacizumab. 
  • GNOSIS: guidelines for neuro-oncology: standards for investigational studies-reporting of phase 1 and phase 2 clinical trials. 
  • Gefitinib (Iressa, ZD1839) and tyrosine kinase inhibitors: the wave of the future in cancer therapy. 
  • Gemcitabine in the management of metastatic breast cancer: a systematic review. 
  • Genome-editing Technologies for Gene and Cell Therapy. 
  • Graphical search for two-stage designs for phase II clinical trials. 
  • HER2-targeted therapy in breast cancer: a systematic review of neoadjuvant trials. 
  • HIV vaccines. Viral envelope fails to deliver? 
  • HPV vaccines: now that they're here, how do we maximize their benefit? 
  • Hemodynamics as surrogate end points for survival in advanced heart failure: an analysis from FIRST. 
  • Holding back the sea: the role for maintenance chemotherapy in metastatic breast cancer. 
  • Hop, skip, and jump: do we need phase II cardiovascular clinical trials? 
  • IL-31 Inhibition as a Therapeutic Approach for the Management of Chronic Pruritic Dermatoses. 
  • Immune correlates of protection for dengue: State of the art and research agenda. 
  • Impact of Patient Characteristics, Prior Therapy, and Sample Type on Tumor Cell Programmed Cell Death Ligand 1 Expression in Patients with Advanced NSCLC Screened for the ATLANTIC Study. 
  • Impact of race on survival in men with metastatic hormone-refractory prostate cancer. 
  • Improving accrual of older persons to cancer treatment trials: a randomized trial comparing an educational intervention with standard information: CALGB 360001. 
  • Insulin-like growth factor axis gene polymorphisms and clinical outcomes in pancreatic cancer. 
  • Investigation of ALPL variant states and clinical outcomes: An analysis of adults and adolescents with hypophosphatasia treated with asfotase alfa. 
  • Investigational drugs in phase II clinical trials for acute coronary syndromes. 
  • Irinotecan plus cisplatin in patients with advanced non-small-cell lung cancer. 
  • Is there a palliative benefit of gemcitabine plus fluoropyrimidines in patients with refractory colorectal cancer? A review of the literature previously presented: poster at the 2008 Gastrointestinal Cancer Symposium (Abstract No. 512). 
  • Local excision of rectal cancer revisited: ACOSOG protocol Z6041. 
  • Long-term Clinical Outcomes of Nonoperative Management With Chemoradiotherapy for Locally Advanced Rectal Cancer in the Veterans Health Administration. 
  • Malaria vaccine efficacy: the difficulty of detecting and diagnosing malaria. 
  • Malignant gliomas in older adults with poor prognostic signs. Getting nowhere, and taking a long time to do it. 
  • Mammalian target of rapamycin inhibition. 
  • Maspin expression in epithelial ovarian cancer and associations with poor prognosis: a Gynecologic Oncology Group study. 
  • Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements. 
  • Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. 
  • Modified cisplatin/interferon α-2b/doxorubicin/5-fluorouracil (PIAF) chemotherapy in patients with no hepatitis or cirrhosis is associated with improved response rate, resectability, and survival of initially unresectable hepatocellular carcinoma. 
  • Modulation of the Coagulation Cascade Using Aptamers. 
  • Monoclonal antibodies for brain tumour treatment. 
  • Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer. 
  • Mutated p53 portends improvement in outcomes when bevacizumab is combined with chemotherapy in advanced/recurrent endometrial cancer: An NRG Oncology study. 
  • New oral anticoagulants in addition to single or dual antiplatelet therapy after an acute coronary syndrome: a systematic review and meta-analysis. 
  • Noncanonical Matrix Metalloprotease 1-Protease-Activated Receptor 1 Signaling Drives Progression of Atherosclerosis. 
  • On the design and the analysis of stratified biomarker trials in the presence of measurement error. 
  • On the estimation of the binomial probability in multistage clinical trials. 
  • Optimal designs for phase II clinical trials with heterogeneous patient populations. 
  • Optimal two-stage log-rank test for randomized phase II clinical trials. 
  • Oral platelet glycoprotein IIb/IIIa inhibition. 
  • Overcoming challenges in designing and implementing a phase II randomized controlled trial using a presurgical model to test a dietary intervention in prostate cancer. 
  • P-value calculation for multistage phase II cancer clinical trials. 
  • PD-L1 Expression and Clinical Outcomes to Cabozantinib, Everolimus, and Sunitinib in Patients with Metastatic Renal Cell Carcinoma: Analysis of the Randomized Clinical Trials METEOR and CABOSUN. 
  • PLX-PAD Cell Treatment of Critical Limb Ischaemia: Rationale and Design of the PACE Trial. 
  • Perifosine as a potential novel anti-telomerase therapy. 
  • Personalized Prediction Model to Risk Stratify Patients With Myelodysplastic Syndromes. 
  • Pharmacokinetic-pharmacodynamic modelling of platelet response to ticagrelor in stable coronary artery disease and prior myocardial infarction patients. 
  • Phase 2 studies of sunitinib and AG013736 in patients with cytokine-refractory renal cell carcinoma. 
  • Phase II cancer clinical trials for biomarker-guided treatments. 
  • Phase II cancer clinical trials with heterogeneous patient populations. 
  • Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test. 
  • Phase II evaluations of cilengitide in asymptomatic patients with androgen-independent prostate cancer: scientific rationale and study design. 
  • Physical activity in patients with advanced-stage cancer: a systematic review of the literature. 
  • Pitfalls of post-treatment PET after de-intensified chemoradiotherapy for HPV-associated oropharynx cancer: Secondary analysis of a phase 2 trial. 
  • Pooled Analysis of Individual Patient Data on Concurrent Chemoradiotherapy for Stage III Non-Small-Cell Lung Cancer in Elderly Patients Compared With Younger Patients Who Participated in US National Cancer Institute Cooperative Group Studies. 
  • Potential role for telavancin in bacteremic infections due to gram-positive pathogens: focus on Staphylococcus aureus. 
  • Prasugrel versus clopidogrel antiplatelet therapy after acute coronary syndrome: matching treatments with patients. 
  • Prasugrel, a third generation thienopyridine and potent platelet inhibitor. 
  • Preclinical and clinical evaluations of ABX-EGF, a fully human anti-epidermal growth factor receptor antibody. 
  • Predicting risk of chemotherapy-induced severe neutropenia: A pooled analysis in individual patients data with advanced lung cancer. 
  • Predictors of Delayed Cerebral Ischemia in Patients with Aneurysmal Subarachnoid Hemorrhage with Asymptomatic Angiographic Vasospasm on Admission. 
  • Predictors of complete responses with denileukin diftitox in cutaneous T-cell lymphoma. 
  • Prevalence and impact of correlative science in breast cancer phase II trials. 
  • Prevalence and incidence of liver enzyme elevations in a pooled oncology clinical trial cohort. 
  • Production and quality control assessment of a GLP-grade immunotoxin, D2C7-(scdsFv)-PE38KDEL, for a phase I/II clinical trial. 
  • Promising survival and concomitant radiation plus temozolomide followed by adjuvant temozolomide. 
  • Prospective Evaluation of Clinical Outcomes Using a Multiplex Liquid Biopsy Targeting Diverse Resistance Mechanisms in Metastatic Prostate Cancer. 
  • Prostate cancer gene therapy. 
  • Prostatic alpha-linolenic acid (ALA) is positively associated with aggressive prostate cancer: a relationship which may depend on genetic variation in ALA metabolism. 
  • Randomized phase II clinical trials. 
  • Randomized phase II trials with a prospective control. 
  • Rationale and design of the AngeLmed for Early Recognition and Treatment of STEMI trial: a randomized, prospective clinical investigation. 
  • Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations. 
  • Reassessing the Role of Surrogate End Points in Drug Development for Heart Failure. 
  • Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma. 
  • Recognition Patterns of the C1/C2 Epitopes Involved in Fc-Mediated Response in HIV-1 Natural Infection and the RV114 Vaccine Trial. 
  • Recommendations for clinical trial evaluation of acute stroke therapies. 
  • Relugolix, an oral gonadotropin-releasing hormone antagonist for the treatment of prostate cancer. 
  • Research participants' high expectations of benefit in early-phase oncology trials: are we asking the right question? 
  • Role of etoposide (VP-16) in preparatory regimens for patients with leukemia or lymphoma undergoing allogeneic bone marrow transplantation. 
  • Sample size and interim analysis issues for dose selection. 
  • Sarcopenia: designing phase IIB trials. 
  • Seamless Phase IIa/IIb and enhanced dose-finding adaptive design. 
  • Second-line chemotherapy for advanced hormone-refractory prostate cancer. 
  • Selection bias, phase II trials, and the FDA accelerated approval process. 
  • Significant associations of mismatch repair gene polymorphisms with clinical outcome of pancreatic cancer. 
  • Similar outcomes between African American and non-African American patients with extensive-stage small-cell lung carcinoma: report from the Cancer and Leukemia Group B. 
  • Single-therapy androgen suppression in men with advanced prostate cancer: a systematic review and meta-analysis. 
  • Soluble markers for the assessment of biological activity with PTK787/ZK 222584 (PTK/ZK), a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor in patients with advanced colorectal cancer from two phase I trials. 
  • Standard of care and future pharmacological treatment options for malignant glioma: an urgent need for screening and identification of novel tumor-specific antigens. 
  • Statistical issues for design and analysis of single-arm multi-stage phase II cancer clinical trials. 
  • Systematic survey of therapeutic trials for metastatic colorectal cancer: room for improvement in the critical pathway. 
  • Technology evaluation: Rexin-G, Epeius Biotechnologies. 
  • Technosphere insulin: inhaled prandial insulin. 
  • The BRAVO Clinical Study Protocol: Oral Varespladib for Inhibition of Secretory Phospholipase A2 in the Treatment of Snakebite Envenoming. 
  • The Molecular Analysis for Therapy Choice (NCI-MATCH) Trial: Lessons for Genomic Trial Design. 
  • The disconnect between phase II and phase III trials of drugs for heart failure. 
  • The effect of filgrastim or pegfilgrastim on survival outcomes of patients with cancer receiving myelosuppressive chemotherapy. 
  • The evolving role of chemotherapy in androgen-independent (hormone-refractory) prostate cancer. 
  • The role of amifostine as a radioprotector. 
  • The role of clinical nonfatal end points in cardiovascular phase II/III clinical trials. 
  • The safety and efficacy of apixaban : where do we stand in 2013? 
  • The use of Bayesian hierarchical models for adaptive randomization in biomarker-driven phase II studies. 
  • Therapeutic misconception in early phase gene transfer trials. 
  • Treatment of newly diagnosed glioblastoma multiforme. 
  • Trials in myocardial infarction. 
  • Uncertain benefit: investigators' views and communications in early phase gene transfer trials. 
  • Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. 
  • Update on neutropenia and myeloid growth factors. 
  • Updated Results of Rituximab Pre- and Post-BEAM with or without 90Yttrium Ibritumomab Tiuxetan during Autologous Transplant for Diffuse Large B-cell Lymphoma. 
  • Use of glycoprotein IIb/IIIa inhibition plus fibrinolysis in acute myocardial infarction. 
  • Usefulness of ST depression with T-wave inversion in leads V(4) to V(6) for predicting one-year mortality in non-ST-elevation acute coronary syndrome (from the Electrocardiographic Analysis of the Global Use of Strategies to Open Occluded Coronary Arteries IIB Trial). 
  • Validity of brain MRI as the primary outcome criterion in multiple sclerosis phase II clinical trials. 
  • Variability in Antinuclear Antibody Testing to Assess Patient Eligibility for Clinical Trials of Novel Treatments for Systemic Lupus Erythematosus. 
  • Vinorelbine (Navelbine) in non-small cell lung cancer: future directions. 
  • Where does a Staphylococcus aureus vaccine stand? 
  • Who will enroll? Predicting participation in a phase II AIDS vaccine trial. 
• 

  Keywords of People

  • Alexander, John Hunter Peel, Professor of Medicine, Medicine, Cardiology
  • Berchuck, Andrew, James M. Ingram Distinguished Professor of Gynecologic Oncology, Obstetrics and Gynecology, Gynecologic Oncology
  • Halabi, Susan, Professor of Biostatistics & Bioinformatics, Biostatistics & Bioinformatics
  • O'Connor, Christopher Michael, Adjunct Professor in the Department of Medicine, Medicine, Clinical Pharmacology
  • Thomas, Melanie Byrne, Associate Professor of Medicine, Medicine, Medical Oncology