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Items: 26

1.

Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer.

André F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Pápai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group.

N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.

PMID:
31091374
2.

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

Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, Liu MC, Carlson G, Hughes G, Diaz-Padilla I, Germa C, Hirawat S, Lu YS.

Lancet Oncol. 2018 Jul;19(7):904-915. doi: 10.1016/S1470-2045(18)30292-4. Epub 2018 May 24.

PMID:
29804902
3.

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

Sellami D, Dharan B, Wilke C, Scherer SJ, Hirawat S.

Ann Oncol. 2017 Nov 1;28(11):2882-2887. doi: 10.1093/annonc/mdx480. Review. No abstract available.

PMID:
28950291
4.

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

Germa C, Miller M, Mukhopadhyay P, Hewes B, Caponigro G, Scherer SJ, Hirawat S.

Ann Oncol. 2017 Aug 1;28(8):2021-2024. doi: 10.1093/annonc/mdx226. No abstract available.

5.

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.

Soulières D, Faivre S, Mesía R, Remenár É, Li SH, Karpenko A, Dechaphunkul A, Ochsenreither S, Kiss LA, Lin JC, Nagarkar R, Tamás L, Kim SB, Erfán J, Alyasova A, Kasper S, Barone C, Turri S, Chakravartty A, Chol M, Aimone P, Hirawat S, Licitra L.

Lancet Oncol. 2017 Mar;18(3):323-335. doi: 10.1016/S1470-2045(17)30064-5. Epub 2017 Jan 26.

PMID:
28131786
6.

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

Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, André F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J.

N Engl J Med. 2016 Nov 3;375(18):1738-1748. Epub 2016 Oct 7. Erratum in: N Engl J Med. 2018 Dec 27;379(26):2582.

7.

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

Weetall M, Davis T, Elfring G, Northcutt V, Cao L, Moon YC, Riebling P, Dali M, Hirawat S, Babiak J, Colacino J, Almstead N, Spiegel R, Peltz SW.

Clin Pharmacol Drug Dev. 2016 Jul;5(4):296-305. doi: 10.1002/cpdd.240. Epub 2016 Feb 2.

8.

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

Massacesi C, Di Tomaso E, Urban P, Germa C, Quadt C, Trandafir L, Aimone P, Fretault N, Dharan B, Tavorath R, Hirawat S.

Onco Targets Ther. 2016 Jan 7;9:203-10. doi: 10.2147/OTT.S89967. eCollection 2016. Review.

9.

Targeting PI3K/mTOR overcomes resistance to HER2-targeted therapy independent of feedback activation of AKT.

O'Brien NA, McDonald K, Tong L, von Euw E, Kalous O, Conklin D, Hurvitz SA, di Tomaso E, Schnell C, Linnartz R, Finn RS, Hirawat S, Slamon DJ.

Clin Cancer Res. 2014 Jul 1;20(13):3507-20. doi: 10.1158/1078-0432.CCR-13-2769. Epub 2014 May 30.

10.

Some practical considerations for phase III studies with biomarker evaluations.

Goteti S, Hirawat S, Massacesi C, Fretault N, Bretz F, Dharan B.

J Clin Oncol. 2014 Mar 10;32(8):854-5. doi: 10.1200/JCO.2013.53.7613. Epub 2014 Feb 3. No abstract available.

PMID:
24493715
11.

Phase Ib study of Buparlisib plus Trastuzumab in patients with HER2-positive advanced or metastatic breast cancer that has progressed on Trastuzumab-based therapy.

Saura C, Bendell J, Jerusalem G, Su S, Ru Q, De Buck S, Mills D, Ruquet S, Bosch A, Urruticoechea A, Beck JT, Di Tomaso E, Sternberg DW, Massacesi C, Hirawat S, Dirix L, Baselga J.

Clin Cancer Res. 2014 Apr 1;20(7):1935-45. doi: 10.1158/1078-0432.CCR-13-1070. Epub 2014 Jan 27.

12.

Challenges in the clinical development of PI3K inhibitors.

Massacesi C, di Tomaso E, Fretault N, Hirawat S.

Ann N Y Acad Sci. 2013 Mar;1280:19-23. doi: 10.1111/nyas.12060. Review.

13.

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

Kerem E, Wilschanski M, Miller NL, Pugatsch T, Cohen T, Blau H, Rivlin J, Shoseyov D, Reha A, Constantine S, Ajayi T, Hirawat S, Elfring GL, Peltz SW, Miller LL.

J Cyst Fibros. 2011 May;10(3):193-200. doi: 10.1016/j.jcf.2011.02.003. Epub 2011 Apr 2.

14.

Chronic ataluren (PTC124) treatment of nonsense mutation cystic fibrosis.

Wilschanski M, Miller LL, Shoseyov D, Blau H, Rivlin J, Aviram M, Cohen M, Armoni S, Yaakov Y, Pugatsch T, Cohen-Cymberknoh M, Miller NL, Reha A, Northcutt VJ, Hirawat S, Donnelly K, Elfring GL, Ajayi T, Kerem E.

Eur Respir J. 2011 Jul;38(1):59-69. doi: 10.1183/09031936.00120910. Epub 2011 Jan 13. Erratum in: Eur Respir J. 2011 Oct;38(4):996. Pugatch, T [corrected to Pugatsch, T].

15.

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

Sermet-Gaudelus I, Boeck KD, Casimir GJ, Vermeulen F, Leal T, Mogenet A, Roussel D, Fritsch J, Hanssens L, Hirawat S, Miller NL, Constantine S, Reha A, Ajayi T, Elfring GL, Miller LL.

Am J Respir Crit Care Med. 2010 Nov 15;182(10):1262-72. doi: 10.1164/rccm.201001-0137OC. Epub 2010 Jul 9.

PMID:
20622033
16.

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

McDonald CM, Henricson EK, Han JJ, Abresch RT, Nicorici A, Elfring GL, Atkinson L, Reha A, Hirawat S, Miller LL.

Muscle Nerve. 2010 Apr;41(4):500-10. doi: 10.1002/mus.21544.

PMID:
19941337
17.

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

Kerem E, Hirawat S, Armoni S, Yaakov Y, Shoseyov D, Cohen M, Nissim-Rafinia M, Blau H, Rivlin J, Aviram M, Elfring GL, Northcutt VJ, Miller LL, Kerem B, Wilschanski M.

Lancet. 2008 Aug 30;372(9640):719-27. doi: 10.1016/S0140-6736(08)61168-X. Epub 2008 Aug 20.

PMID:
18722008
18.

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

Du M, Liu X, Welch EM, Hirawat S, Peltz SW, Bedwell DM.

Proc Natl Acad Sci U S A. 2008 Feb 12;105(6):2064-9. doi: 10.1073/pnas.0711795105. Epub 2008 Feb 6.

19.

A Phase I dose-finding study using an innovative sequential biweekly schedule of irinotecan followed 24 hours later by capecitabine.

Hirawat S, Kolitz J, Lichtman SM, Allen SL, Villani G, Gonzales A, Fricano M, Budman DR.

Cancer Invest. 2007 Apr-May;25(3):148-53.

PMID:
17530484
20.

PTC124 targets genetic disorders caused by nonsense mutations.

Welch EM, Barton ER, Zhuo J, Tomizawa Y, Friesen WJ, Trifillis P, Paushkin S, Patel M, Trotta CR, Hwang S, Wilde RG, Karp G, Takasugi J, Chen G, Jones S, Ren H, Moon YC, Corson D, Turpoff AA, Campbell JA, Conn MM, Khan A, Almstead NG, Hedrick J, Mollin A, Risher N, Weetall M, Yeh S, Branstrom AA, Colacino JM, Babiak J, Ju WD, Hirawat S, Northcutt VJ, Miller LL, Spatrick P, He F, Kawana M, Feng H, Jacobson A, Peltz SW, Sweeney HL.

Nature. 2007 May 3;447(7140):87-91. Epub 2007 Apr 22.

PMID:
17450125
21.

Safety, tolerability, and pharmacokinetics of PTC124, a nonaminoglycoside nonsense mutation suppressor, following single- and multiple-dose administration to healthy male and female adult volunteers.

Hirawat S, Welch EM, Elfring GL, Northcutt VJ, Paushkin S, Hwang S, Leonard EM, Almstead NG, Ju W, Peltz SW, Miller LL.

J Clin Pharmacol. 2007 Apr;47(4):430-44.

PMID:
17389552
22.

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

Hurwitz HI, Cohen RB, McGovren JP, Hirawat S, Petros WP, Natsumeda Y, Yoshinari T.

Cancer Chemother Pharmacol. 2007 Jan;59(1):139-47. Epub 2006 Jul 4.

PMID:
16819636
23.

The androgen receptor: structure, mutations, and antiandrogens.

Hirawat S, Budman DR, Kreis W.

Cancer Invest. 2003 Jun;21(3):400-17. Review. Erratum in: Cancer Invest. 2003;21(6):960-2.

PMID:
12901287
24.

Langerhans' cell histiocytosis in the parotid gland.

Darvishian F, Hirawat S, Teichberg S, Wolk D, Allen SL, Hajdu SI.

Ann Clin Lab Sci. 2002 Spring;32(2):201-6.

PMID:
12017204
25.
26.

Talc induced transfusion independence in a patient with myelodysplasia.

Hirawat S, Arunabh A, Schulman P.

Leuk Res. 2001 Mar;25(3):263-5.

PMID:
11226524

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