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Expanding Role of Data Science and Bioinformatics in Drug Discovery and Development

Clinical pharmacology and therapeutics, 2018-01, Vol.103 (1), p.47-49

Fingert, Howard J.

2018

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Phase II Study of Alisertib, a Selective Aurora A Kinase Inhibitor, in Relapsed and Refractory Aggressive B- and T-Cell Non-Hodgkin Lymphomas

Journal of clinical oncology, 2014-01, Vol.32 (1), p.44-50

2014

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Phase I Study of Aurora A Kinase Inhibitor MLN8237 in Advanced Solid Tumors: Safety, Pharmacokinetics, Pharmacodynamics, and Bioavailability of Two Oral Formulations

Clinical cancer research, 2012-09, Vol.18 (17), p.4775-4784

2012

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Safety, Pharmacokinetic, and Pharmacodynamic Phase I Dose-Escalation Trial of PF-00562271, an Inhibitor of Focal Adhesion Kinase, in Advanced Solid Tumors

Journal of clinical oncology, 2012-05, Vol.30 (13), p.1527-1533

2012

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Investigational Aurora A kinase inhibitor alisertib (MLN8237) as an enteric-coated tablet formulation in non-hematologic malignancies: Phase 1 dose-escalation study

Investigational new drugs, 2014-12, Vol.32 (6), p.1181-1187

2014

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Assessing proarrhythmic potential of drugs when optimal studies are infeasible

The American heart journal, 2009-05, Vol.157 (5), p.827-836.e1

2009

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An exploratory phase 2 study of investigational Aurora A kinase inhibitor alisertib (MLN8237) in acute myelogenous leukemia and myelodysplastic syndromes

Leukemia research reports, 2014, Vol.3 (2), p.58-61

2014

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Drug-induced QTc interval prolongation: A proposal towards an efficient and safe anticancer drug development

European journal of cancer (1990), 2008-03, Vol.44 (4), p.494-500

2008

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A Phase I Pharmacokinetic and Biological Correlative Study of Oblimersen Sodium (Genasense, G3139), an Antisense Oligonucleotide to the Bcl-2 mRNA, and of Docetaxel in Patients with Hormone-Refractory Prostate Cancer

Clinical cancer research, 2004-08, Vol.10 (15), p.5048-5057

2004

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Deamination of Glutamine is a Prerequisite for Optimal Asparagine Deamination by Asparaginases In Vivo (CCG-1961)

Anticancer research, 2004-03, Vol.24 (2C), p.1121-1125

2004

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Cardiac safety, risk management, and oncology drug development

Clinical cancer research, 2006-06, Vol.12 (12), p.3646-3647

2006

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In vitro evidence that myocardial ischemia resulting from 5-fluorouracil chemotherapy is due to protein kinase C-mediated vasoconstriction of vascular smooth muscle

Cancer research (Chicago, Ill.), 1993-07, Vol.53 (13), p.3028-3033

1993

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Phase I Pharmacokinetic/Pharmacodynamic Study of MLN8237, an Investigational, Oral, Selective Aurora A Kinase Inhibitor, in Patients with Advanced Solid Tumors

Clinical cancer research, 2012-09, Vol.18 (17), p.4764-4774

2012

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Phase II study of MLN8237 (alisertib), an investigational Aurora A kinase inhibitor, in patients with platinum-resistant or -refractory epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

Gynecologic oncology, 2012-10, Vol.127 (1), p.63-69

2012

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Brain natriuretic peptide: potential adjunct for cardiac risk assessment and management during treatment with experimental anticancer agents

The AAPS journal, 2007-01, Vol.9 (2), p.E115-E116

2007

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Phase I study of the selective Aurora A kinase inhibitor MLN8054 in patients with advanced solid tumors: safety, pharmacokinetics, and pharmacodynamics

Molecular cancer therapeutics, 2010-10, Vol.9 (10), p.2844-2852

2010

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Phase 1 study of MLN8054, a selective inhibitor of Aurora A kinase in patients with advanced solid tumors

Cancer chemotherapy and pharmacology, 2011-04, Vol.67 (4), p.945-954

2011

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Recommended phase (Ph) II dose (RP2D) selection for investigational Aurora A kinase (AAK) inhibitor MLN8237 (Alisertib; A) combined with paclitaxel (P): Clinical pharmacokinetics (PK), drug-drug interaction (DDI) assessment, and translational exposure-efficacy modeling

Journal of clinical oncology, 2013-05, Vol.31 (15_suppl), p.2598-2598

2013

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Abstract C122: Phase 1b relative bioavailability (BA) study of enteric coated tablet (ECT) in reference to powder in capsule (PIC) formulation of the investigational drug alisertib (MLN8237), an Aurora A Kinase (AAK) inhibitor, in patients with advanced nonhematologic malignancies

Molecular cancer therapeutics, 2011-11, Vol.10 (11_Supplement), p.C122-C122

2011

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Cyclin E, a potential prognostic marker for breast cancer

Cancer research (Chicago, Ill.), 1994-01, Vol.54 (2), p.380-385

1994

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Clinical pharmacologic considerations for the phase II/III dose/regimen of the investigational Aurora A kinase (AAK) inhibitor MLN8237 (alisertib): Pharmacokinetics (PK), pharmacodynamics (PD), and exposure-safety relationships

Journal of clinical oncology, 2012-05, Vol.30 (15_suppl), p.2597-2597

2012

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Cytotoxic, cell cycle, and chromosomal effects of methylxanthines in human tumor cells treated with alkylating agents

Cancer research (Chicago, Ill.), 1986-05, Vol.46 (5), p.2463-2467

1986

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Phase 2 Study of MLN8237, An Investigational Aurora A Kinase (AAK) Inhibitor In Patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS)

Blood, 2010-11, Vol.116 (21), p.3273-3273

2010

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Phase I Study of An Investigational Aurora A Kinase Inhibitor MLN8237 In Patients with Advanced Hematologic Malignancies

Blood, 2010-11, Vol.116 (21), p.2799-2799

2010

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Baseline heart rate-corrected QT and eligibility for clinical trials in oncology

Journal of clinical oncology, 2003-09, Vol.21 (17), p.3378-3379

2003

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Expanding Role of Data Science and Bioinformatics in Drug Discovery and Development

Phase II Study of Alisertib, a Selective Aurora A Kinase Inhibitor, in Relapsed and Refractory Aggressive B- and T-Cell Non-Hodgkin Lymphomas

Phase I Study of Aurora A Kinase Inhibitor MLN8237 in Advanced Solid Tumors: Safety, Pharmacokinetics, Pharmacodynamics, and Bioavailability of Two Oral Formulations

Safety, Pharmacokinetic, and Pharmacodynamic Phase I Dose-Escalation Trial of PF-00562271, an Inhibitor of Focal Adhesion Kinase, in Advanced Solid Tumors

Investigational Aurora A kinase inhibitor alisertib (MLN8237) as an enteric-coated tablet formulation in non-hematologic malignancies: Phase 1 dose-escalation study

Assessing proarrhythmic potential of drugs when optimal studies are infeasible

An exploratory phase 2 study of investigational Aurora A kinase inhibitor alisertib (MLN8237) in acute myelogenous leukemia and myelodysplastic syndromes

Drug-induced QTc interval prolongation: A proposal towards an efficient and safe anticancer drug development

A Phase I Pharmacokinetic and Biological Correlative Study of Oblimersen Sodium (Genasense, G3139), an Antisense Oligonucleotide to the Bcl-2 mRNA, and of Docetaxel in Patients with Hormone-Refractory Prostate Cancer

Deamination of Glutamine is a Prerequisite for Optimal Asparagine Deamination by Asparaginases In Vivo (CCG-1961)

Cardiac safety, risk management, and oncology drug development

In vitro evidence that myocardial ischemia resulting from 5-fluorouracil chemotherapy is due to protein kinase C-mediated vasoconstriction of vascular smooth muscle

Phase I Pharmacokinetic/Pharmacodynamic Study of MLN8237, an Investigational, Oral, Selective Aurora A Kinase Inhibitor, in Patients with Advanced Solid Tumors

Phase II study of MLN8237 (alisertib), an investigational Aurora A kinase inhibitor, in patients with platinum-resistant or -refractory epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

Brain natriuretic peptide: potential adjunct for cardiac risk assessment and management during treatment with experimental anticancer agents

Phase I study of the selective Aurora A kinase inhibitor MLN8054 in patients with advanced solid tumors: safety, pharmacokinetics, and pharmacodynamics

Phase 1 study of MLN8054, a selective inhibitor of Aurora A kinase in patients with advanced solid tumors

Recommended phase (Ph) II dose (RP2D) selection for investigational Aurora A kinase (AAK) inhibitor MLN8237 (Alisertib; A) combined with paclitaxel (P): Clinical pharmacokinetics (PK), drug-drug interaction (DDI) assessment, and translational exposure-efficacy modeling

Abstract C122: Phase 1b relative bioavailability (BA) study of enteric coated tablet (ECT) in reference to powder in capsule (PIC) formulation of the investigational drug alisertib (MLN8237), an Aurora A Kinase (AAK) inhibitor, in patients with advanced nonhematologic malignancies

Cyclin E, a potential prognostic marker for breast cancer

Clinical pharmacologic considerations for the phase II/III dose/regimen of the investigational Aurora A kinase (AAK) inhibitor MLN8237 (alisertib): Pharmacokinetics (PK), pharmacodynamics (PD), and exposure-safety relationships

Cytotoxic, cell cycle, and chromosomal effects of methylxanthines in human tumor cells treated with alkylating agents

Phase 2 Study of MLN8237, An Investigational Aurora A Kinase (AAK) Inhibitor In Patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS)

Phase I Study of An Investigational Aurora A Kinase Inhibitor MLN8237 In Patients with Advanced Hematologic Malignancies

Baseline heart rate-corrected QT and eligibility for clinical trials in oncology

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