William F. Novotny
Genentech
PharmacokineticsCancerInternal medicineSurgeryPathologyOncologyAdverse effectChemotherapyVascular endothelial growth factorBevacizumabProstate cancerIrinotecanFluorouracilIn patientRecombinant DNACancer researchColorectal cancerMonoclonal antibodyMedicineGastroenterology
53Publications
29H-index
23.4kCitations
Publications 53
Newest
Aim This study aims to assess the potential effects of zanubrutinib on the activity of cytochrome P450 (CYP) enzymes and drug transporter proteins using a cocktail probe approach. Methods Patients received single oral doses of probe drugs alone and after at least 8 days of treatment with zanubrutinib 160 mg twice daily in a single-sequence study in 18 healthy male volunteers. Simultaneous doses of 10 mg warfarin (CYP2C9) and 2 mg midazolam (CYP3A) were administered on Day 1 and Day 14, 0.25 mg d...
Source
#1Song MuH-Index: 2
#2Borje DarpoH-Index: 1
Last. Ying C. OuH-Index: 2
view all 10 authors...
This thorough QT (TQT) study evaluated the effect of zanubrutinib on electrocardiogram (ECG) parameters by using concentration-QTc (C-QTc) analysis as the primary analysis for this study. Part A of the study determined the safety and tolerability of a single supratherapeutic dose of zanubrutinib (480 mg) in healthy volunteers. Part B was a randomized, blinded, placebo- and positive-controlled, four-way crossover, TQT study of single therapeutic (160-mg) and supratherapeutic (480-mg) doses of zan...
1 CitationsSource
#1Ying C. OuH-Index: 2
#2Richard A. Preston (UM: University of Miami)H-Index: 26
Last. Srikumar SahasranamanH-Index: 8
view all 8 authors...
AbstractThe pharmacokinetics and safety of single-dose zanubrutinib (80 mg) were assessed in subjects with mild, moderate, and severe hepatic impairment (n = 6 each, Child–Pugh class A, B, and C) r...
6 CitationsSource
#1Song MuH-Index: 2
#2Zhiyu TangH-Index: 3
Last. Srikumar SahasranamanH-Index: 1
view all 7 authors...
Zanubrutinib (BGB-3111) is a potent Bruton’s tyrosine kinase inhibitor with promising clinical activity in B-cell malignancies. Zanubrutinib was shown to be mainly metabolized through cytochrome P450 3A (CYP3A) in vitro. We evaluated the effect of steady-state rifampin (a strong CYP3A inducer) and steady-state itraconazole (a strong CYP3A inhibitor) on the pharmacokinetics (PK), safety, and tolerability of zanubrutinib in healthy Asian and non-Asian subjects. In this open-label, two-part clinica...
11 CitationsSource
#1Pedram Razavi (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 27
#2Bob T. Li (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 33
Last. Jorge S. Reis-Filho (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 135
view all 43 authors...
Accurate identification of tumor-derived somatic variants in plasma circulating cell-free DNA (cfDNA) requires understanding of the various biological compartments contributing to the cfDNA pool. We sought to define the technical feasibility of a high-intensity sequencing assay of cfDNA and matched white blood cell DNA covering a large genomic region (508 genes; 2 megabases; >60,000× raw depth) in a prospective study of 124 patients with metastatic cancer, with contemporaneous matched tumor tiss...
149 CitationsSource
#1Pedram Razavi (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 27
#2Bob T. Li (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 33
Last. José Baselga (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 169
view all 20 authors...
LBA11516The full, final text of this abstract will be available at abstracts.asco.org at 7:30 AM (EDT) on Saturday, June 3, 2017, and in the Annual Meeting Proceedings online supplement to the June 20, 2017, issue of the Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.
8 CitationsSource
#1Eric A. Klein (Cleveland Clinic)H-Index: 117
#2Tara MaddalaH-Index: 16
Last. Cristina Magi-Galluzzi (Cleveland Clinic)H-Index: 70
view all 9 authors...
4560 Background: Standardized, quantitative tools are needed to improve discrimination of clinically aggressive from indolent prostate cancer at diagnosis. We previously identified multiple genes and biological pathways in radical prostatectomy (RP) specimens associated with clinical recurrence and adverse pathology. We evaluated whether measurement of these genes in prostate needle biopsy (Bx) specimens predicts adverse pathology - high grade (GS ≥ 4+3) and/or non-organ-confined disease (pT3) -...
12 CitationsSource
#1Yang Pan (Amgen)H-Index: 7
#1Yang Pan (Amgen)H-Index: 2
Last. Pamela M. Holland (Amgen)H-Index: 18
view all 9 authors...
Evaluation of pharmacodynamic biomarkers in a Phase 1a trial of dulanermin (rhApo2L/TRAIL) in patients with advanced tumours
35 CitationsSource
4663 Background: Prostate biopsy may not adequately sample small, secondary or tertiary Gleason pattern tumors which can drive clinical outcome. We conducted a study to determine whether tumor-deri...
1 CitationsSource
39 Background: Prostate biopsy may not adequately sample small, secondary or tertiary Gleason pattern tumors which can drive clinical outcome. We conducted a study to determine whether tumor-derived gene expression profiling could identify a distinct underlying biology associated with clinical recurrence (cR) after radical prostatectomy (RP) across both the primary and highest Gleason pattern (GP) samples. Methods: All patients (pts) with clinical stage T1/T2 prostate cancer treated with RP at C...
1 CitationsSource