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Article ; Online: Bioequivalence of 240 mg Apalutamide Tablets and Preparation in Aqueous Food Vehicles for Alternative Administration.

Yu, Alex / Van Uffel, Mieke / Jiao, Juhui J / Rosales, Rosamerlinda / Erba, Maura / Haddish-Berhane, Nahor

Clinical pharmacology in drug development

2023 Volume 13, Issue 4, Page(s) 432–439

Abstract: A 240-mg single tablet has been developed with the focus of reducing the pill burden of the apalutamide daily dose of 240 mg (4 × 60-mg tablets). An open-label, randomized, single-dose phase 1 study with a 2-sequence and 2-period crossover design in ... ...

Abstract	A 240-mg single tablet has been developed with the focus of reducing the pill burden of the apalutamide daily dose of 240 mg (4 × 60-mg tablets). An open-label, randomized, single-dose phase 1 study with a 2-sequence and 2-period crossover design in healthy men determined the bioequivalence of a 240-mg single tablet versus the currently available 4 × 60-mg tablets (Part 1, N = 74) and assessed effect of a high-fat meal (Part 2, N = 21) on apalutamide maximum plasma concentration (C
MeSH term(s)	Male ; Humans ; Therapeutic Equivalency ; Thiohydantoins ; Tablets ; Food
Chemical Substances	apalutamide ; Thiohydantoins ; Tablets
Language	English
Publishing date	2023-11-20
Publishing country	United States
Document type	Randomized Controlled Trial ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2649010-9
ISSN	2160-7648 ; 2160-763X
ISSN (online)	2160-7648
ISSN	2160-763X
DOI	10.1002/cpdd.1346
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Article ; Online: Teclistamab: Mechanism of action, clinical, and translational science.

Guo, Yue / Quijano Cardé, Natalia A / Kang, Lijuan / Verona, Raluca / Banerjee, Arnob / Kobos, Rachel / Chastain, Katherine / Uhlar, Clarissa / Pillarisetti, Kodandaram / Doyle, Margaret / Smit, Jennifer / Haddish-Berhane, Nahor / Ouellet, Daniele

Clinical and translational science

2024 Volume 17, Issue 1, Page(s) e13717

Abstract: Multiple myeloma (MM) remains incurable despite improvements in treatment options. B-cell maturation antigen (BCMA) is predominantly expressed in B-lineage cells and represents a promising new target for MM. Teclistamab ( ... ...

Abstract	Multiple myeloma (MM) remains incurable despite improvements in treatment options. B-cell maturation antigen (BCMA) is predominantly expressed in B-lineage cells and represents a promising new target for MM. Teclistamab (TECVAYLI
MeSH term(s)	Humans ; Translational Science, Biomedical ; B-Cell Maturation Antigen ; Multiple Myeloma/drug therapy ; Antibodies, Bispecific ; Antineoplastic Agents ; CD3 Complex
Chemical Substances	B-Cell Maturation Antigen ; Antibodies, Bispecific ; Antineoplastic Agents ; CD3 Complex
Language	English
Publishing date	2024-01-24
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13717
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Article ; Online: Demonstrating Bioequivalence for Two Dose Strengths of Niraparib and Abiraterone Acetate Dual-Action Tablets Versus Single Agents: Utility of Clinical Study Data Supplemented with Modeling and Simulation.

Yu, Alex / Hazra, Anasuya / Jiao, James Juhui / Hellemans, Peter / Mitselos, Anna / Tian, Hui / Ruixo, Juan Jose Perez / Haddish-Berhane, Nahor / Ouellet, Daniele / Russu, Alberto

Clinical pharmacokinetics

2024 Volume 63, Issue 4, Page(s) 511–527

MeSH term(s)	Humans ; Therapeutic Equivalency ; Indazoles/pharmacokinetics ; Indazoles/administration & dosage ; Male ; Piperidines/pharmacokinetics ; Piperidines/administration & dosage ; Abiraterone Acetate/pharmacokinetics ; Abiraterone Acetate/administration & dosage ; Tablets ; Aged ; Middle Aged ; Prostatic Neoplasms, Castration-Resistant/drug therapy ; Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Models, Biological ; Biological Availability ; Cross-Over Studies ; Aged, 80 and over ; Computer Simulation ; Prednisone/pharmacokinetics ; Prednisone/administration & dosage
Chemical Substances	Indazoles ; Piperidines ; niraparib (HMC2H89N35) ; Abiraterone Acetate (EM5OCB9YJ6) ; Tablets ; Prednisone (VB0R961HZT)
Language	English
Publishing date	2024-03-04
Publishing country	Switzerland
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Multicenter Study
ZDB-ID	197627-8
ISSN	1179-1926 ; 0312-5963
ISSN (online)	1179-1926
ISSN	0312-5963
DOI	10.1007/s40262-023-01340-5
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Zs.A 1246: Show issues

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Article ; Online: Optimization of clinical dosing schedule to manage neutropenia: learnings from semi-mechanistic modeling simulation approach.

Guo, Yue / Haddish-Berhane, Nahor / Xie, Hong / Ouellet, Daniele

Journal of pharmacokinetics and pharmacodynamics

2019 Volume 47, Issue 1, Page(s) 47–58

Abstract: Neutropenia is a common side-effect of oncology drugs. We aimed to study the impact of exposure and dosing schedule on neutropenia to guide selection of dosing schedules that minimize neutropenia potential while maintaining the desired minimum ... ...

Abstract	Neutropenia is a common side-effect of oncology drugs. We aimed to study the impact of exposure and dosing schedule on neutropenia to guide selection of dosing schedules that minimize neutropenia potential while maintaining the desired minimum concentration (C
MeSH term(s)	Antineoplastic Agents/administration & dosage ; Area Under Curve ; Cell Proliferation/drug effects ; Computer Simulation ; Drug Administration Schedule ; Half-Life ; Humans ; Neutropenia/drug therapy ; Neutrophils/drug effects
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2019-12-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	2041601-5
ISSN	1573-8744 ; 1567-567X
ISSN (online)	1573-8744
ISSN	1567-567X
DOI	10.1007/s10928-019-09667-y
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Article ; Online: Determination and Confirmation of Recommended Ph2 Dose of Amivantamab in Epidermal Growth Factor Receptor Exon 20 Insertion Non-Small Cell Lung Cancer.

Haddish-Berhane, Nahor / Su, Yaming / Russu, Alberto / Thayu, Meena / Knoblauch, Roland E / Mehta, Jaydeep / Xie, John / Gibbs, Eric / Sun, Yu-Nien / Zhou, Honghui

Clinical pharmacology and therapeutics

2023 Volume 115, Issue 3, Page(s) 468–477

Abstract: Amivantamab has demonstrated durable responses with a tolerable safety profile in non-small cell lung cancer with EGFR exon 20 insertions (Ex20ins) who progressed after prior platinum chemotherapy. Data supporting the amivantamab recommended phase II ... ...

Abstract	Amivantamab has demonstrated durable responses with a tolerable safety profile in non-small cell lung cancer with EGFR exon 20 insertions (Ex20ins) who progressed after prior platinum chemotherapy. Data supporting the amivantamab recommended phase II dose (RP2D) in this patient population are presented. Pharmacokinetic (PK) analysis and population PK (PopPK) modeling were conducted using serum concentration data obtained following amivantamab intravenous administration (140-1,750 mg). Pharmacodynamics (PDs) were evaluated using depletion of soluble EGFR and MET. Exposure-response (E-R) analyses were performed using the primary efficacy end point of objective response rate in patients with EGFR Ex20ins. The E-R relationship for safety was explored for adverse events of clinical interest. Amivantamab exhibited linear PKs at 350-1,750 mg dose levels following administration, with no maximum tolerated dose identified. A two-compartment PopPK model with linear clearance adequately described the observed PKs. Body weight was a covariate of clearance and volume of distribution in the central compartment. PopPK modeling showed that a weight-based, 2-tier (< 80 and ≥ 80 kg) dosing strategy reduces PK variability and provides comparable exposure across 2 weight groups, with 87% of patients achieving exposures above the target threshold. The final confirmed RP2D of amivantamab was 1,050 mg for < 80 kg (1,400 mg for ≥ 80 kg) weekly in cycle 1 (28 days) and every 2 weeks thereafter. No significant exposure-efficacy or safety correlation was observed. In conclusion, the amivantamab RP2D is supported by PK, PD, safety, and efficacy analyses. E-R analyses confirmed that the current regimen provides durable efficacy with tolerable safety.
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; ErbB Receptors/genetics ; Exons ; Antibodies, Bispecific
Chemical Substances	amivantamab-vmjw ; ErbB Receptors (EC 2.7.10.1) ; Antibodies, Bispecific
Language	English
Publishing date	2023-10-12
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.3064
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Zs.A 20: Show issues

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Article ; Online: The pH-altering agent omeprazole affects rate but not the extent of ibrutinib exposure.

de Jong, Jan / Haddish-Berhane, Nahor / Hellemans, Peter / Jiao, James / Sukbuntherng, Juthamas / Ouellet, Daniele

Cancer chemotherapy and pharmacology

2018 Volume 82, Issue 2, Page(s) 299–308

Abstract: Purpose: This drug-interaction study evaluated the effect of omeprazole, a proton-pump inhibitor, on ibrutinib's pharmacokinetics (PK) in healthy participants.: Methods: This open-label, sequential-design study included 20 healthy adults aged 18-55 ... ...

Abstract	Purpose: This drug-interaction study evaluated the effect of omeprazole, a proton-pump inhibitor, on ibrutinib's pharmacokinetics (PK) in healthy participants. Methods: This open-label, sequential-design study included 20 healthy adults aged 18-55 years. Ibrutinib (560 mg, single dose) was administered after an overnight fast alone on day 1 and with omeprazole on day 7. Omeprazole (40 mg) alone was administered on days 3-6, 1 h before breakfast; and after an overnight fast on day 7, followed by ibrutinib 2 h later. Blood was sampled on days 1 and 7 for up to 48 h postdose, and the standard PK parameters for ibrutinib and PCI-45227 were summarized using descriptive statistics. The effect of omeprazole on ibrutinib's PK was determined by assessing geometric mean ratios (GMRs) and 90% CIs. Mechanistic modeling was performed using the BTK-receptor occupancy (RO) model. Results: AUC Conclusions: The decrease in C
MeSH term(s)	Adult ; Drug Interactions ; Female ; Humans ; Hydrogen-Ion Concentration/drug effects ; Male ; Middle Aged ; Models, Biological ; Omeprazole/adverse effects ; Omeprazole/blood ; Omeprazole/pharmacology ; Proton Pump Inhibitors/blood ; Proton Pump Inhibitors/pharmacology ; Pyrazoles/adverse effects ; Pyrazoles/blood ; Pyrazoles/pharmacokinetics ; Pyrimidines/adverse effects ; Pyrimidines/blood ; Pyrimidines/pharmacokinetics
Chemical Substances	Proton Pump Inhibitors ; Pyrazoles ; Pyrimidines ; ibrutinib (1X70OSD4VX) ; Omeprazole (KG60484QX9)
Language	English
Publishing date	2018-06-07
Publishing country	Germany
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	6820-2
ISSN	1432-0843 ; 0344-5704 ; 0943-9404
ISSN (online)	1432-0843
ISSN	0344-5704 ; 0943-9404
DOI	10.1007/s00280-018-3613-9
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Zs.A 1420: Show issues

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Article ; Online: Cardiac Safety Assessment of Lazertinib: Findings From Patients With

Jang, Seong Bok / Kim, Kyeong Bae / Sim, Sujin / Cho, Byoung Chul / Ahn, Myung-Ju / Han, Ji-Youn / Kim, Sang-We / Lee, Ki Hyeong / Cho, Eun Kyung / Haddish-Berhane, Nahor / Mehta, Jaydeep / Oh, Se-Woong

JTO clinical and research reports

2021 Volume 2, Issue 10, Page(s) 100224

Abstract: Introduction: Lazertinib is a potent, irreversible, brain-penetrant, mutant-selective, and wild-type-sparing third-generation EGFR tyrosine kinase inhibitor (TKI), creating a wide therapeutic index. Cardiovascular adverse events (AEs), including QT ... ...

Abstract	Introduction: Lazertinib is a potent, irreversible, brain-penetrant, mutant-selective, and wild-type-sparing third-generation EGFR tyrosine kinase inhibitor (TKI), creating a wide therapeutic index. Cardiovascular adverse events (AEs), including QT prolongation, decreased left ventricular ejection fraction (LVEF), and heart failure, have emerged as potential AEs with certain EGFR TKI therapies. Methods: Cardiac safety of lazertinib was evaluated in TKI-tolerant adults with Results: Preclinical evaluation revealed little to no physiological effect on the basis of electrocardiogram, electrophysiological, proarrhythmic, and hemodynamic parameters. Clinical evaluation of 181 patients revealed no clinically relevant QTcF prolongation by centralized electrocardiogram in any patient and at any dose level. The predicted magnitude of QTcF value increase at maximum steady-state plasma concentration for the therapeutic dose of lazertinib (240 mg/d) was 2.2 msec (upper bound of the two-sided 90% confidence interval: 3.6 msec). No patient had clinically relevant LVEF decrease (i.e., minimum postbaseline LVEF value of <50% and a maximum decrease in LVEF value from baseline of ≥10 percentage points). Cardiac failure-associated AE occurred in one patient (grade 2 decreased LVEF) and resolved without any dose modifications. Conclusions: Our first-in-human study, together with preclinical data, indicates that lazertinib is not associated with increased cardiac risk.
Language	English
Publishing date	2021-09-08
Publishing country	United States
Document type	Journal Article
ISSN	2666-3643
ISSN (online)	2666-3643
DOI	10.1016/j.jtocrr.2021.100224
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Article ; Online: Effects of food and race on the pharmacokinetics of lazertinib in healthy subjects and patients with EGFR mutation-positive advanced non-small cell lung cancer.

Huh, Ki Young / Lim, Yeji / Yoon, Deok Yong / Hwang, Jun Gi / Sim, Sujin / Kang, Jiah / Wang, Jangyoung / Kim, Mikyung / Jang, Seong Bok / Shreeve, S Martin / Mehta, Jaydeep / Haddish-Berhane, Nahor / Oh, Jaeseong / Lee, SeungHwan / Yu, Kyung-Sang

Lung cancer (Amsterdam, Netherlands)

2022 Volume 175, Page(s) 112–120

Abstract: Objectives: Lazertinib is a potent, irreversible, brain-penetrant, mutant-selective, and wild type-sparing third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor indicated for advanced non-small cell lung cancer (NSCLC). The ... ...

Abstract	Objectives: Lazertinib is a potent, irreversible, brain-penetrant, mutant-selective, and wild type-sparing third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor indicated for advanced non-small cell lung cancer (NSCLC). The study aimed to evaluate the effects of food and race on the pharmacokinetics (PK) of lazertinib from a healthy volunteer trial and PK data from NSCLC patients with EGFR mutation. Materials and methods: An open-label, single-dose, two-period, single-sequence crossover study was conducted in healthy subjects with two race groups (non-Asian and Asian). Subjects orally received a single dose of lazertinib 240 mg in fasted and fed state (high-fat meal) in each period separated by a 21-day washout. An open-label, multicenter, phase 1/2 study was conducted in Asian and non-Asian patients with NSCLC. Patients were given oral lazertinib 20-320 mg once daily in fasted state continuously in 21-day cycles. PK parameters were evaluated using non-compartmental analysis. Results: A total of 24 healthy subjects (12 non-Asians and 12 Asians) and 52 NSCLC patients (22 non-Asians and 30 Asians) were evaluated. The change in the overall systemic exposure of lazertinib at fed state was less than 15%. Non-Asians showed 58-76% of the systemic exposure than Asians in healthy subjects. In contrast, there were no significant differences in systemic exposure by race both after single and multiple doses among NSCLC patients. Conclusion: Lazertinib can be taken with or without food considering the comparable systemic exposures related to food. Although effect of race was not consistent across studies, there was no evidence for dose adjustment based on race.
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Cross-Over Studies ; ErbB Receptors/genetics ; Healthy Volunteers ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Mutation/genetics ; Protein Kinase Inhibitors/therapeutic use ; Protein Kinase Inhibitors/pharmacology ; Asian People ; Fasting
Chemical Substances	EGFR protein, human (EC 2.7.10.1) ; ErbB Receptors (EC 2.7.10.1) ; lazertinib (4A2Y23XK11) ; Protein Kinase Inhibitors
Language	English
Publishing date	2022-12-02
Publishing country	Ireland
Document type	Clinical Trial, Phase II ; Clinical Trial, Phase I ; Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632771-0
ISSN	1872-8332 ; 0169-5002
ISSN (online)	1872-8332
ISSN	0169-5002
DOI	10.1016/j.lungcan.2022.11.021
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Zs.A 2135: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Bench to bedside translation of antibody drug conjugates using a multiscale mechanistic PK/PD model: a case study with brentuximab-vedotin.

Shah, Dhaval K / Haddish-Berhane, Nahor / Betts, Alison

Journal of pharmacokinetics and pharmacodynamics

2012 Volume 39, Issue 6, Page(s) 643–659

Abstract: To build a multiscale mechanism based pharmacokinetic-pharmacodynamic (PK/PD) model for antibody drug conjugates (ADCs), using brentuximab-vedotin as an example, for preclinical to clinical translation of ADC efficacy. Brentuximab-vedotin experimental ... ...

Abstract	To build a multiscale mechanism based pharmacokinetic-pharmacodynamic (PK/PD) model for antibody drug conjugates (ADCs), using brentuximab-vedotin as an example, for preclinical to clinical translation of ADC efficacy. Brentuximab-vedotin experimental data, collected from diverse publications, were employed in the following steps to build and validate the model: (1) characterization of ADC and payload PK at the cellular level, (2) characterization of payload PK in plasma and tumor tissue of xenograft mouse, (3) characterization of ADC PK in mouse plasma, (4) prediction of the tumor payload concentrations in xenograft mouse by integrating parameters obtained from steps 1-3 with the novel tumor disposition model for ADC, (5) characterization of preclinical brentuximab-vedotin tumor growth inhibition data using the novel PK/PD model, (6) characterization of ADC and payload PK in cancer patients, and (7) prediction of clinical responses of brentuximab-vedotin using the PK/PD model, by integrating PK parameters obtained from step 6, and translated mouse parameters from step 5; and comparing them with clinical trial results. The tumor disposition model was able to accurately predict xenograft tumor and plasma payload concentrations. PK/PD model predicted progression free survival rates and complete response rates for brentuximab-vedotin in patients were comparable to the observed clinical results. It is essential to understand and characterize the disposition of ADC and payload, at the cellular and physiological level, to predict the clinical outcome of ADC. A first of its kind mechanistic model has been developed for ADCs, which can integrate preclinical biomeasures and PK/PD data, to predict clinical response.
MeSH term(s)	Animals ; Brentuximab Vedotin ; Cell Line, Tumor ; Disease-Free Survival ; Drug Evaluation, Preclinical ; Humans ; Immunoconjugates/administration & dosage ; Immunoconjugates/pharmacokinetics ; Mice ; Models, Biological ; Neoplasms/drug therapy ; Neoplasms/metabolism ; Translational Medical Research ; Xenograft Model Antitumor Assays
Chemical Substances	Immunoconjugates ; Brentuximab Vedotin (7XL5ISS668)
Language	English
Publishing date	2012-11-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	2041601-5
ISSN	1573-8744 ; 1567-567X
ISSN (online)	1573-8744
ISSN	1567-567X
DOI	10.1007/s10928-012-9276-y
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Article ; Online: Correction to: A Translational Quantitative Systems Pharmacology Model for CD3 Bispecific Molecules: Application to Quantify T Cell-Mediated Tumor Cell Killing by P-Cadherin LP DART®.

Betts, Alison / Haddish-Berhane, Nahor / Shah, Dhaval K / van der Graaf, Piet H / Barletta, Frank / King, Lindsay / Clark, Tracey / Kamperschroer, Cris / Root, Adam / Hooper, Andrea / Chen, Xiaoying

The AAPS journal

2019 Volume 21, Issue 4, Page(s) 73

Abstract: Typesetting error occurred and Figure 1a and Figure 1b were altered during the uploading process. The original article has been corrected. ...

Abstract	Typesetting error occurred and Figure 1a and Figure 1b were altered during the uploading process. The original article has been corrected.
Language	English
Publishing date	2019-06-04
Publishing country	United States
Document type	Published Erratum
ISSN	1550-7416
ISSN (online)	1550-7416
DOI	10.1208/s12248-019-0348-4
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