S. Hirawat

发表

PI3K inhibitors as new cancer therapeutics: implications for clinical trial design

E. di Tomaso, P. Aimone, C. Massacesi, 2016, OncoTargets and therapy.

Challenges in the clinical development of PI3K inhibitors

C. Massacesi, N. Fretault, S. Hirawat, 2013, Annals of the New York Academy of Sciences.

Some practical considerations for phase III studies with biomarker evaluations.

Frank Bretz, F. Bretz, C. Massacesi, 2014, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Circulating tumor DNA as a novel tool to shape clinical trial designs with the potential to impact outcomes: a focus on PI3K inhibitors.

S. Scherer, D. Sellami, B. Dharan, 2017, Annals of oncology : official journal of the European Society for Medical Oncology.

Safety, Tolerability, and Pharmacokinetics of PTC124, a Nonaminoglycoside Nonsense Mutation Suppressor, Following Single‐ and Multiple‐Dose Administration to Healthy Male and Female Adult Volunteers

S. Peltz, S. Paushkin, L. Miller, 2007, Journal of clinical pharmacology.

PTC124 treatment over 3 months improves pharmacodynamic and clinical parameters in patients with nonsense-mutation-mediated CF

H. Blau, E. Kerem, M. Wilschanski, 2008 .

Ataluren (PTC124) Induces CFTR Protein Expression and Activity in Children with Nonsense Mutation Cystic Fibrosis

F. Vermeulen, I. Sermet-Gaudelus, T. Ajayi, 2010 .

A phase I study of the safety and pharmacokinetics of edotecarin (J-107088), a novel topoisomerase I inhibitor, in patients with advanced solid tumors

H. Hurwitz, W. Petros, R. Cohen, 2006, Cancer Chemotherapy and Pharmacology.

A Phase I Dose-Finding Study Using an Innovative Sequential Biweekly Schedule of Irinotecan Followed 24 Hours Later by Capecitabine

J. Kolitz, D. Budman, S. Hirawat, 2007, Cancer investigation.

Ataluren (PTC124) induces cystic fibrosis transmembrane conductance regulator protein expression and activity in children with nonsense mutation cystic fibrosis.

F. Vermeulen, I. Sermet-Gaudelus, T. Ajayi, 2010, American journal of respiratory and critical care medicine.

Case Report: Langerhans' Cell Histiocytosis in the Parotid Gland

F. Darvishian, S. Teichberg, S. Hirawat, 2002 .

Langerhans' cell histiocytosis in the parotid gland.

F. Darvishian, S. Teichberg, S. Hirawat, 2002, Annals of clinical and laboratory science.

Abstract 4756: In vivo efficacy of combined targeting of CDK4/6, ER and PI3K signaling in ER+ breast cancer

R. Finn, D. Slamon, S. Hirawat, 2014 .

Alpelisib (ALP) + fulvestrant (FUL) for advanced breast cancer (ABC): Results of the phase III SOLAR-1 trial.

H. Rugo, H. Iwata, D. Juric, 2018, Annals of oncology : official journal of the European Society for Medical Oncology.

Phase 1 Study of Safety, Tolerability, and Pharmacokinetics of PTC299, an Inhibitor of Stress‐Regulated Protein Translation

S. Peltz, Thomas P. Davis, G. Elfring, 2016, Clinical pharmacology in drug development.

Phase II Trial of Oral Panobinostat (LBH589) in Patients with Refractory Cutaneous T-Cell Lymphoma (CTCL).

J. Becker, R. Dummer, C. Lebbé, 2008 .

Discovery and development of novel therapies in advanced breast cancer: rapid development of ribociclib

G. Caponigro, S. Scherer, C. Germa, 2017, Annals of oncology : official journal of the European Society for Medical Oncology.

Targeting activated PI3K/mTOR signaling overcomes acquired resistance to CDK4/6-based therapies in preclinical models of hormone receptor-positive breast cancer

D. Slamon, S. Hurvitz, K. Rose, 2020, Breast Cancer Research.

Alpelisib for PIK3CA‐Mutated, Hormone Receptor–Positive Advanced Breast Cancer

H. Rugo, H. Iwata, D. Juric, 2019, The New England journal of medicine.

The Androgen Receptor: Structure, Mutations, and Antiandrogens

D. Budman, S. Hirawat, W. Kreis, 2003, Cancer investigation.

PTC124 targets genetic disorders caused by nonsense mutations

Meenal Patel, Feng He, Masataka Kawana, 2007, Nature.

The 6‐minute walk test as a new outcome measure in Duchenne muscular dystrophy

Jay J. Han, Alina Nicorici, R. Abresch, 2010, Muscle & nerve.

Targeting PI3K/mTOR Overcomes Resistance to HER2-Targeted Therapy Independent of Feedback Activation of AKT

C. Schnell, R. Finn, D. Slamon, 2014, Clinical Cancer Research.

Phase Ib Study of Buparlisib plus Trastuzumab in Patients with HER2-Positive Advanced or Metastatic Breast Cancer That Has Progressed on Trastuzumab-Based Therapy

Guy Jerusalem, Cristina Saura, J. Baselga, 2014, Clinical Cancer Research.

Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial.

L. Chow, A. Bardia, N. Harbeck, 2018, The Lancet. Oncology.

Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer.

E. Winer, G. Hortobagyi, K. Blackwell, 2016, The New England journal of medicine.

Buparlisib and paclitaxel in patients with platinum-pretreated recurrent or metastatic squamous cell carcinoma of the head and neck (BERIL-1): a randomised, double-blind, placebo-controlled phase 2 trial.

Sung-Bae Kim, A. Dechaphunkul, É. Remenár, 2017, The Lancet. Oncology.

PI3K inhibitors as new cancer therapeutics: implications for clinical trial design

E. di Tomaso, P. Aimone, C. Massacesi, 2016, OncoTargets and therapy.

Chronic ataluren (PTC124) treatment of nonsense mutation cystic fibrosis

H. Blau, E. Kerem, T. Ajayi, 2011, European Respiratory Journal.

PTC124 is an orally bioavailable compound that promotes suppression of the human CFTR-G542X nonsense allele in a CF mouse model

S. Peltz, D. Bedwell, M. Du, 2008, Proceedings of the National Academy of Sciences.

Recombinant human erythropoietin use in hemolytic anemia due to prosthetic heart valves: A promising treatment

S. Hirawat, S. Lichtman, S. Allen, 2001, American journal of hematology.

Effectiveness of PTC124 treatment of cystic fibrosis caused by nonsense mutations: a prospective phase II trial

Eitan Kerem, B. Kerem, H. Blau, 2008, The Lancet.

Abstract GS2-05: First-line ribociclib vs placebo with goserelin and tamoxifen or a non-steroidal aromatase inhibitor in premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer: Results from the randomized phase III MONALEESA-7 trial

A. Bardia, N. Harbeck, D. Tripathy, 2018 .

Ambulatory quantitative waking and sleeping cough assessment in patients with cystic fibrosis.

Temitayo Ajayi, Eitan Kerem, S. Peltz, 2011, Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society.

Quantitative cough assessment in cystic fibrosis (CF)

S. Peltz, E. Kerem, M. Wilschanski, 2008 .

Abstract 4150: Anti-tumor activity of the PI3K/mTOR pathway inhibitors alpelisib (BYL719) and everolimus (RAD001) in xenograft models of acquired resistance to CDK-4/6 targeted therapy

D. Slamon, S. Scherer, S. Hurvitz, 2017 .

Following Single-and Multiple-Dose Administration to Healthy Male and Female Adult Safety , Tolerability , and Pharmacokinetics of PTC 124 , a Nonaminoglycoside Nonsense Mutation

S. Peltz, S. Paushkin, L. Miller, 2007 .

Abstract P4-22-16: First-line ribociclib + letrozole in patients with HR+, HER2– advanced breast cancer (ABC) presenting with visceral metastases or bone-only disease: A subgroup analysis of the MONALEESA-2 trial

E. Winer, M. Campone, H. Burris, 2017 .

Abstract P4-22-18: Phase Ib safety, efficacy, and molecular analysis of ribociclib (LEE011) plus letrozole for the treatment of ER+, HER2– advanced breast cancer

D. Juric, A. Wardley, P. Munster, 2017 .

Characteristics of Thrombocytopenia in Patients Treated with Oral Panobinostat (LBH589).

M. Woo, S. Hirawat, S. Spence, 2009 .

Population Pharmacokinetics of Panobinostat (LBH589) in Patients with Advanced Solid Tumors and Hematologic Malignancies Following Intravenous and Oral Administration.

M. Woo, S. Hirawat, J. Schindler, 2009 .

G.P.3.05 Phase 2 study of PTC124 for nonsense mutation suppression therapy of Duchenne muscular dystrophy (DMD)

R. Finkel, B. Wong, K. Flanigan, 2007, Neuromuscular Disorders.

Efficacy of Panobinostat in Phase II Study in Patients with Relapsed/Refractory Hodgkin Lymphoma (HL) After High-Dose Chemotherapy with Autologous Stem Cell Transplant.

A. Younes, V. Ribrag, S. Hirawat, 2009 .

Updated results from MONALEESA-2, a phase 3 trial of first-line ribociclib + letrozole in hormone receptor-positive (HR+), HER2-negative (HER2–), advanced breast cancer (ABC).

E. Winer, G. Hortobagyi, K. Blackwell, 2017 .

41* PTC124 activity in CF patients carrying stop mutations: results of a phase 2 study

H. Blau, E. Kerem, M. Wilschanski, 2007 .

Circulating tumor DNA as a novel tool to shape clinical trial designs with the potential to impact outcomes: a focus on PI3K inhibitors.

S. Scherer, D. Sellami, B. Dharan, 2017 .

Phase II study of oral panobinostat (LBH589), a potent pan-deacetylase inhibitor, in patients with refractory Cutaneous T-cell Lymphoma (CTCL)

P. Zinzani, F. Vanaclocha, M. Duvic, 2008 .

Elucidation of the metabolic and elimination pathways of panobinostat (LBH589) using [14C]-panobinostat.

S. Clive, M. Woo, M. Kagan, 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

PTC124 induces CFTR full-length production and activity in children with nonsense-mutation-mediated CF

I. Sermet-Gaudelus, L. Miller, G. Elfring, 2008 .