Model-based clinical pharmacology profiling of ipilimumab in patients with advanced melanoma.

PubWeight™: 0.81‹?›

🔗 View Article (PMC 4168385)

Published in Br J Clin Pharmacol on July 01, 2014

Authors

Yan Feng1, Eric Masson, David Dai, Susan M Parker, David Berman, Amit Roy

Author Affiliations

1: Bristol-Myers Squibb Company, Princeton, NJ, USA.

Associated clinical trials:

Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab | NCT01515189

Articles cited by this

A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med (1999) 82.86

Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med (2010) 67.34

Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med (2011) 26.90

Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol (2009) 8.68

A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res (2009) 5.99

Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol (2010) 5.91

Immunostimulatory monoclonal antibodies for cancer therapy. Nat Rev Cancer (2007) 5.65

Anti-cytotoxic T-lymphocyte antigen-4 antibody: the first in an emerging class of immunomodulatory antibodies for cancer treatment. J Clin Oncol (2008) 4.23

General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn (2001) 3.21

A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med (2011) 2.86

Phase I/II study of ipilimumab for patients with metastatic melanoma. J Clin Oncol (2008) 2.79

Development of ipilimumab: contribution to a new paradigm for cancer immunotherapy. Semin Oncol (2010) 2.51

Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention. Clin Pharmacokinet (2011) 2.09

Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet (2010) 2.08

Ipilimumab efficacy and safety in patients with advanced melanoma: a retrospective analysis of HLA subtype from four trials. Cancer Immun (2010) 2.07

Approximations of the target-mediated drug disposition model and identifiability of model parameters. J Pharmacokinet Pharmacodyn (2008) 1.97

Population pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor Xa inhibitor--in patients undergoing major orthopaedic surgery. Clin Pharmacokinet (2008) 1.39

Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development. BioDrugs (2010) 1.26

Phase I study of vorinostat in patients with advanced solid tumors and hepatic dysfunction: a National Cancer Institute Organ Dysfunction Working Group study. J Clin Oncol (2010) 1.15

Population pharmacokinetic analysis of varenicline in adult smokers. Br J Clin Pharmacol (2009) 1.15

Fundamentals of population pharmacokinetic modelling: validation methods. Clin Pharmacokinet (2012) 1.10

A guide to rational dosing of monoclonal antibodies. Clin Pharmacokinet (2012) 1.08

Exposure-response relationships of the efficacy and safety of ipilimumab in patients with advanced melanoma. Clin Cancer Res (2013) 1.04

The clinical pharmacology of therapeutic monoclonal antibodies in the treatment of malignancy; have the magic bullets arrived? Br J Clin Pharmacol (2008) 0.99

Essential pharmacokinetic information for drug dosage decisions: a concise visual presentation in the drug label. Clin Pharmacol Ther (2011) 0.83

Population pharmacokinetics of tapentadol immediate release (IR) in healthy subjects and patients with moderate or severe pain. Clin Pharmacokinet (2010) 0.82

Population pharmacokinetics and exposure-response of albinterferon alfa-2b. J Clin Pharmacol (2011) 0.77

Articles by these authors

Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med (2012) 35.24

Low diagnostic yield of elective coronary angiography. N Engl J Med (2010) 9.38

A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res (2009) 5.99

Innovative approaches for designing and analyzing adaptive dose-ranging trials. J Biopharm Stat (2007) 4.78

An immune-active tumor microenvironment favors clinical response to ipilimumab. Cancer Immunol Immunother (2011) 4.02

Experimental stroke induces massive, rapid activation of the peripheral immune system. J Cereb Blood Flow Metab (2006) 3.91

Impact of National Clinical Guideline recommendations for revascularization of persistently occluded infarct-related arteries on clinical practice in the United States. Arch Intern Med (2011) 3.73

Splenic atrophy in experimental stroke is accompanied by increased regulatory T cells and circulating macrophages. J Immunol (2006) 3.28

A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med (2011) 2.86

Treatments, trends, and outcomes of acute myocardial infarction and percutaneous coronary intervention. J Am Coll Cardiol (2010) 2.86

T- and B-cell-deficient mice with experimental stroke have reduced lesion size and inflammation. J Cereb Blood Flow Metab (2007) 2.75

Racial and ethnic differences in the treatment of acute myocardial infarction: findings from the Get With the Guidelines-Coronary Artery Disease program. Circulation (2010) 2.53

Development of ipilimumab: contribution to a new paradigm for cancer immunotherapy. Semin Oncol (2010) 2.51

Contemporary mortality risk prediction for percutaneous coronary intervention: results from 588,398 procedures in the National Cardiovascular Data Registry. J Am Coll Cardiol (2010) 2.49

A phase I study of intravenous LBH589, a novel cinnamic hydroxamic acid analogue histone deacetylase inhibitor, in patients with refractory hematologic malignancies. Clin Cancer Res (2006) 2.33

Lipid levels in patients hospitalized with coronary artery disease: an analysis of 136,905 hospitalizations in Get With The Guidelines. Am Heart J (2008) 2.06

Discharge to a skilled nursing facility and subsequent clinical outcomes among older patients hospitalized for heart failure. Circ Heart Fail (2011) 1.99

Changes in myocardial infarction guideline adherence as a function of patient risk: an end to paradoxical care? J Am Coll Cardiol (2011) 1.92

Patterns and intensity of medical therapy in patients undergoing percutaneous coronary intervention. JAMA (2011) 1.88

Phase I study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PTK787/ZK 222584 administered twice daily in patients with advanced cancer. J Clin Oncol (2005) 1.86

Pre-processing Agilent microarray data. BMC Bioinformatics (2007) 1.84

Use of cardiac resynchronization therapy in patients hospitalized with heart failure. Circulation (2008) 1.81

Bacterial motility complexes require the actin-like protein, MreB and the Ras homologue, MglA. EMBO J (2009) 1.71

Safety and efficacy of drug-eluting stents in older patients with chronic kidney disease: a report from the linked CathPCI Registry-CMS claims database. J Am Coll Cardiol (2011) 1.68

Risk score for in-hospital ischemic stroke mortality derived and validated within the Get With the Guidelines-Stroke Program. Circulation (2010) 1.66

Contraindicated medication use in dialysis patients undergoing percutaneous coronary intervention. JAMA (2009) 1.63

Blockade of cytotoxic T-lymphocyte antigen-4 by ipilimumab results in dysregulation of gastrointestinal immunity in patients with advanced melanoma. Cancer Immun (2010) 1.57

Clinical effectiveness of coronary stents in elderly persons: results from 262,700 Medicare patients in the American College of Cardiology-National Cardiovascular Data Registry. J Am Coll Cardiol (2009) 1.55

A virus causes cancer by inducing massive chromosomal instability through cell fusion. Curr Biol (2007) 1.51

Contemporary use of adjunctive thrombectomy during primary percutaneous coronary intervention for ST-elevation myocardial infarction in the United States. Catheter Cardiovasc Interv (2012) 1.45

Mitochondrial localization of human PANK2 and hypotheses of secondary iron accumulation in pantothenate kinase-associated neurodegeneration. Ann N Y Acad Sci (2004) 1.42

Phase I clinical and pharmacokinetic study of PTK/ZK, a multiple VEGF receptor inhibitor, in patients with liver metastases from solid tumours. Eur J Cancer (2005) 1.42

Safety and clinical activity of ipilimumab in melanoma patients with brain metastases: retrospective analysis of data from a phase 2 trial. Melanoma Res (2011) 1.35

Temporal trends and geographic variation of lower-extremity amputation in patients with peripheral artery disease: results from U.S. Medicare 2000-2008. J Am Coll Cardiol (2012) 1.33

Hospital variability in the rate of finding obstructive coronary artery disease at elective, diagnostic coronary angiography. J Am Coll Cardiol (2011) 1.24

Cognitive intervention for community-dwelling older persons with memory problems: telemedicine versus face-to-face treatment. Int J Geriatr Psychiatry (2005) 1.22

Reactive oxygen species and imbalance of calcium homeostasis contributes to curcumin induced programmed cell death in Leishmania donovani. Apoptosis (2008) 1.22

Targeting protein-protein interactions: suppression of Stat3 dimerization with rationally designed small-molecule, nonpeptidic SH2 domain binders. Chembiochem (2008) 1.21

Temporal trends in and factors associated with bleeding complications among patients undergoing percutaneous coronary intervention: a report from the National Cardiovascular Data CathPCI Registry. J Am Coll Cardiol (2012) 1.17

Randomized phase I pharmacokinetic study of ipilimumab with or without one of two different chemotherapy regimens in patients with untreated advanced melanoma. Cancer Immun (2013) 1.17

Tanespimycin with bortezomib: activity in relapsed/refractory patients with multiple myeloma. Br J Haematol (2010) 1.14

Ipilimumab increases activated T cells and enhances humoral immunity in patients with advanced melanoma. J Immunother (2012) 1.14

Association of race/ethnicity with clinical risk factors, quality of care, and acute outcomes in patients hospitalized with heart failure. Am Heart J (2011) 1.13

Tanespimycin and bortezomib combination treatment in patients with relapsed or relapsed and refractory multiple myeloma: results of a phase 1/2 study. Br J Haematol (2011) 1.12

Enhanced mortality risk prediction with a focus on high-risk percutaneous coronary intervention: results from 1,208,137 procedures in the NCDR (National Cardiovascular Data Registry). JACC Cardiovasc Interv (2013) 1.10

Results from a prospective, international, epidemiologic study of invasive candidiasis in children and neonates. Pediatr Infect Dis J (2012) 1.09

Acceptance, panic, and partial recovery the pattern of usage of drug-eluting stents after introduction in the U.S. (a report from the American College of Cardiology/National Cardiovascular Data Registry). JACC Cardiovasc Interv (2010) 1.09

Tanespimycin monotherapy in relapsed multiple myeloma: results of a phase 1 dose-escalation study. Br J Haematol (2010) 1.07

A risk score for in-hospital death in patients admitted with ischemic or hemorrhagic stroke. J Am Heart Assoc (2013) 1.04

Exposure-response relationships of the efficacy and safety of ipilimumab in patients with advanced melanoma. Clin Cancer Res (2013) 1.04

Percutaneous coronary intervention and drug-eluting stent use among patients ≥85 years of age in the United States. J Am Coll Cardiol (2012) 1.03

Annular pancreas: a rare cause of duodenal obstruction in adults. Indian J Surg (2010) 1.01

Aberrant promoter methylation profile and association with survival in patients with non-small cell lung cancer. Clin Cancer Res (2006) 1.01

Quality of care and in-hospital outcomes in patients with coronary heart disease in rural and urban hospitals (from Get With the Guidelines-Coronary Artery Disease Program). Am J Cardiol (2009) 0.99

Left circumflex occlusion in acute myocardial infarction (from the National Cardiovascular Data Registry). Am J Cardiol (2011) 0.98

Short- and long-term outcomes of coronary stenting in women versus men: results from the National Cardiovascular Data Registry Centers for Medicare & Medicaid services cohort. Circulation (2012) 0.96

Cholesterol levels and in-hospital mortality in patients with acute decompensated heart failure. Am Heart J (2008) 0.95

A novel ATP-binding cassette transporter, ABCG6 is involved in chemoresistance of Leishmania. Mol Biochem Parasitol (2007) 0.94

Ipilimumab in treatment-naive and previously treated patients with metastatic melanoma: retrospective analysis of efficacy and safety data from a phase II trial. J Immunother (2012) 0.94

Betulinic acid, a catalytic inhibitor of topoisomerase I, inhibits reactive oxygen species-mediated apoptotic topoisomerase I-DNA cleavable complex formation in prostate cancer cells but does not affect the process of cell death. Cancer Res (2007) 0.94

High mortality risks after major lower extremity amputation in Medicare patients with peripheral artery disease. Am Heart J (2013) 0.94

Use of intensive lipid-lowering therapy in patients hospitalized with acute coronary syndrome: an analysis of 65,396 hospitalizations from 344 hospitals participating in Get With The Guidelines (GWTG). Am Heart J (2010) 0.93

Quality of care for acute coronary syndrome patients with known atherosclerotic disease: results from the Get With the Guidelines Program. Circulation (2009) 0.93

Clinical profile of dasatinib in Asian and non-Asian patients with chronic myeloid leukemia. Int J Hematol (2009) 0.92

Age-dependent effects of testosterone in experimental stroke. J Cereb Blood Flow Metab (2008) 0.92

Incidence and predictors of stroke associated with percutaneous coronary intervention. Am J Cardiol (2009) 0.92

Effect of race and ethnicity on outcomes with drug-eluting and bare metal stents: results in 423 965 patients in the linked National Cardiovascular Data Registry and centers for Medicare & Medicaid services payer databases. Circulation (2013) 0.92

Serine protease HTRA1 antagonizes transforming growth factor-β signaling by cleaving its receptors and loss of HTRA1 in vivo enhances bone formation. PLoS One (2013) 0.92

Droplet microfluidics platform for highly sensitive and quantitative detection of malaria-causing Plasmodium parasites based on enzyme activity measurement. ACS Nano (2012) 0.91

Association of insurance status with inpatient treatment for coronary artery disease: findings from the Get With the Guidelines program. Am Heart J (2010) 0.91

Utilization of secondary prevention therapies in patients with nonobstructive coronary artery disease identified during cardiac catheterization: insights from the National Cardiovascular Data Registry Cath-PCI Registry. Circ Cardiovasc Qual Outcomes (2010) 0.90

Differential effects of dosing regimen on the safety and efficacy of dasatinib: retrospective exposure-response analysis of a Phase III study. Clin Pharmacol (2013) 0.90

Withanolide Z, a new chlorinated withanolide from Withania somnifera. Planta Med (2008) 0.89

Airway obstruction and ventilator dependency in young children with congenital cardiac defects: a role for self-expanding metal stents. Intensive Care Med (2002) 0.88

The importance of consistent, high-quality acute myocardial infarction and heart failure care results from the American Heart Association's Get with the Guidelines Program. J Am Coll Cardiol (2011) 0.88

Differential induction of Leishmania donovani bi-subunit topoisomerase I-DNA cleavage complex by selected flavones and camptothecin: activity of flavones against camptothecin-resistant topoisomerase I. Nucleic Acids Res (2006) 0.87

Quantifying the impact of nonadherence patterns on exposure to oral immunosuppressants. Ther Clin Risk Manag (2011) 0.87

Association between periprocedural bleeding and long-term outcomes following percutaneous coronary intervention in older patients. JACC Cardiovasc Interv (2012) 0.86

Pathologic changes in ipilimumab-related hepatitis in patients with metastatic melanoma. Dig Dis Sci (2012) 0.86

Clinically relevant QTc prolongation is not associated with current dose schedules of LBH589 (panobinostat). J Clin Oncol (2008) 0.85

Functional alteration of a dimeric insecticidal lectin to a monomeric antifungal protein correlated to its oligomeric status. PLoS One (2011) 0.85

Gene expression profiling of whole blood in ipilimumab-treated patients for identification of potential biomarkers of immune-related gastrointestinal adverse events. J Transl Med (2013) 0.85

Self-assembled ferrimagnet--polymer composites for magnetic recording media. Nano Lett (2010) 0.85

Influence of hospital length of stay for heart failure on quality of care. Am J Cardiol (2008) 0.85

An optical method to quantify the density of ligands for cell adhesion receptors in three-dimensional matrices. J R Soc Interface (2010) 0.85

Comparative effectiveness of drug-eluting versus bare-metal stents in elderly patients undergoing revascularization of chronic total coronary occlusions: results from the National Cardiovascular Data Registry, 2005-2008. JACC Cardiovasc Interv (2012) 0.84

Temporal trends in percutaneous coronary intervention outcomes among older patients in the United States. Am Heart J (2013) 0.84

Patterns of cardiac marker surveillance after elective percutaneous coronary intervention and implications for the use of periprocedural myocardial infarction as a quality metric: a report from the National Cardiovascular Data Registry (NCDR). J Am Coll Cardiol (2008) 0.84

Monolayer assembly of ferrimagnetic Co(x)Fe(3-x)O4 nanocubes for magnetic recording. Nano Lett (2014) 0.84

Metabolism and disposition of vatalanib (PTK787/ZK-222584) in cancer patients. Drug Metab Dispos (2006) 0.84

Is heart failure guideline adherence being underestimated? The impact of therapeutic contraindications. Am Heart J (2012) 0.84

Comparison of palanosetron, granisetron and ondansetron as anti-emetics for prevention of postoperative nausea and vomiting in patients undergoing middle ear surgery. J Indian Med Assoc (2011) 0.84

Trends in smoking cessation counseling: experience from American Heart Association-get with the guidelines. Clin Cardiol (2012) 0.84

Model-based approach for optimization of atazanavir dose recommendations for HIV-infected pediatric patients. Antimicrob Agents Chemother (2011) 0.83

PTK787/ZK 222584, a small molecule tyrosine kinase receptor inhibitor of vascular endothelial growth factor (VEGF), has modest activity in myelofibrosis with myeloid metaplasia. Leuk Res (2007) 0.83

Importance of characterizing determinants of variability in exposure: application to dasatinib in subjects with chronic myeloid leukemia. J Clin Pharmacol (2008) 0.82