Lokesh Jain

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Innovation at the Intersection of Clinical Trials and Real‐World Data Science to Advance Patient Care

Dyfrig A. Hughes, Vasu Chandrasekaran, D. Hughes, 2018, Clinical and translational science.

The role of vascular endothelial growth factor SNPs as predictive and prognostic markers for major solid tumors

D. Venzon, R. Danesi, W. Figg, 2009, Molecular Cancer Therapeutics.

IDENTIFICATION OF CLINICAL, LABORATORY AND GENETIC COVARIATES FOR PHARMACOKINETICS, EFFICACY AND TOXICITY OF SORAFENIB IN PATIENTS WITH SOLID TUMORS

Lokesh Jain, 2009 .

Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity.

Lori Minasian, Liang Cao, Christina M. Annunziata, 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

A Phase II Clinical Trial of Sorafenib in Androgen-Independent Prostate Cancer

S. Steinberg, E. Posadas, J. Wright, 2008, Clinical Cancer Research.

Sorafenib Is an Inhibitor of UGT1A1 but Is Metabolized by UGT1A9: Implications of Genetic Variants on Pharmacokinetics and Hyperbilirubinemia

G. Giaccone, E. Kohn, D. Venzon, 2012, Clinical Cancer Research.

Final analysis of a phase II trial using sorafenib for metastatic castration‐resistant prostate cancer

S. Steinberg, D. Draper, J. Wright, 2009, BJU international.

Hand-Foot Skin Reaction Increases with Cumulative Sorafenib Dose and with Combination Anti-Vascular Endothelial Growth Factor Therapy

H. Kong, S. Steinberg, E. Kohn, 2009, Clinical Cancer Research.

Development of a rapid and sensitive LC-MS/MS assay for the determination of sorafenib in human plasma.

W. Figg, L. Jain, E. Gardner, 2008, Journal of pharmaceutical and biomedical analysis.

ResearchHypertension and hand-foot skin reactions related to VEGFR 2 genotype and improved clinical outcome following bevacizumab and sorafenib

G. Giaccone, E. Kohn, D. Venzon, 2015 .

Population pharmacokinetic analysis of sorafenib in patients with solid tumours.

G. Giaccone, E. Kohn, D. Mould, 2011, British journal of clinical pharmacology.

Hypertension and hand-foot skin reactions related to VEGFR2 genotype and improved clinical outcome following bevacizumab and sorafenib

G. Giaccone, E. Kohn, D. Venzon, 2010, Journal of experimental & clinical cancer research : CR.

Randomized discontinuation trial of sorafenib (BAY 43-9006)

L. Jain, J. Venitz, William D. Figg, II, 2006, Cancer biology & therapy.

Correlative studies of a phase I trial of combination anti-vascular endothelial growth factor (VEGF) therapy with sorafenib and bevacizumab

E. Kohn, L. Minasian, W. Figg, 2008 .

A Phase I Study of PF-04929113 (SNX-5422), an Orally Bioavailable Heat Shock Protein 90 Inhibitor, in Patients with Refractory Solid Tumor Malignancies and Lymphomas

G. Giaccone, W. Zein, B. Houk, 2011, Clinical Cancer Research.

Lack of Association Between Excretion of Sorafenib in Sweat and Hand‐Foot Skin Reaction

H. Kong, L. Jain, E. Gardner, 2010, Pharmacotherapy.

Pivotal Dose of Pembrolizumab: A Dose‐Finding Strategy for Immuno‐Oncology

Anson K. Abraham, Manash S. Chatterjee, M. Chatterjee, 2021, Clinical pharmacology and therapeutics.

Abstract CT042: Pembrolizumab 400 mg Q6W dosing: First clinical outcomes data from Keynote-555 cohort B in metastatic melanoma patients

E. Chartash, D. Alwis, V. Sinha, 2020, Tumor Biology.

A six-weekly dosing schedule for pembrolizumab in patients with cancer based on evaluation using modelling and simulation.

L. Siu, E. Chartash, V. Sinha, 2020, European journal of cancer.

Physiologically Based Pharmacokinetic Modeling for Selumetinib to Evaluate Drug‐Drug Interactions and Pediatric Dose Regimens

Diansong Zhou, L. Jain, H. Tomkinson, 2021, Journal of clinical pharmacology.

Pembrolizumab Exposure–Response Assessments Challenged by Association of Cancer Cachexia and Catabolic Clearance

J. Riess, V. Sinha, K. Mayawala, 2018, Clinical Cancer Research.

Pembrolizumab Plus Pegylated Interferon alfa-2b or Ipilimumab for Advanced Melanoma or Renal Cell Carcinoma: Dose-Finding Results from the Phase Ib KEYNOTE-029 Study

T. Choueiri, M. Atkins, A. Ribas, 2018, Clinical Cancer Research.

Population pharmacokinetics and exposure–response of selumetinib and its N‐desmethyl metabolite in pediatric patients with neurofibromatosis type 1 and inoperable plexiform neurofibromas

Karen So, Diansong Zhou, H. Tomkinson, 2021, Cancer Chemotherapy and Pharmacology.

Pharmacokinetic–pharmacodynamic (dipeptidyl peptidase‐4 inhibition) model to support dose rationale in diabetes patients, including those with renal impairment, for once‐weekly administered omarigliptin

L. Jain, D. Tatosian, E. Kauh, 2019, British journal of clinical pharmacology.

A six-weekly (Q6W) dosing schedule for pembrolizumab based on an exposure-response (E-R) evaluation using modeling and simulation.

E. Chartash, D. Alwis, V. Sinha, 2018 .

Abstract CT143: Pembrolizumab bioavailability after subcutaneous administration: analysis from the KEYNOTE-555 Cohort A in metastatic melanoma

F. Gheyas, E. Chartash, D. Alwis, 2021, Clinical Trials.

KEYNOTE-555 Cohort B: Efficacy, safety, and PK of pembrolizumab (pembro) 400 mg every 6 weeks (Q6W) as 1L therapy for advanced melanoma.

James R. Anderson, A. Arance, P. Ruff, 2021 .

A randomized, double-blind trial evaluating the efficacy and safety of monotherapy with the once-weekly dipeptidyl peptidase-4 inhibitor omarigliptin in people with type 2 diabetes.

P. Home, R. Shankar, S. Engel, 2017, Diabetes research and clinical practice.

Determination of PF-04928473 in human plasma using liquid chromatography with tandem mass spectrometry.

G. Giaccone, B. Houk, W. Figg, 2010, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

Mechanistic Basis for Maximally Efficacious Dose of Pembrolizumab

D. Alwis, K. Mayawala, L. Jain, 2021, Clinical pharmacology and therapeutics.

Dose Finding Versus Speed in Seamless Immuno‐Oncology Drug Development

A. Tse, D. Alwis, K. Mayawala, 2017, Journal of clinical pharmacology.

Immunogenicity of pembrolizumab in patients with advanced tumors

K. Mayawala, L. Jain, D. D. de Alwis, 2019, Journal of Immunotherapy for Cancer.

Sorafenib Is an Inhibitor of UGT1A1 but Is Metabolized by UGT1A9: Implications of Genetic Variants on Pharmacokinetics and Hyperbilirubinemia

G. Giaccone, E. Kohn, D. Venzon, 2012, Clinical Cancer Research.