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Items: 38

1.

Phase Ib study of the MEK inhibitor cobimetinib (GDC-0973) in combination with the PI3K inhibitor pictilisib (GDC-0941) in patients with advanced solid tumors.

Shapiro GI, LoRusso P, Kwak E, Pandya S, Rudin CM, Kurkjian C, Cleary JM, Pilat MJ, Jones S, de Crespigny A, Fredrickson J, Musib L, Yan Y, Wongchenko M, Hsieh HJ, Gates MR, Chan IT, Bendell J.

Invest New Drugs. 2019 Apr 24. doi: 10.1007/s10637-019-00776-6. [Epub ahead of print]

PMID:
31020608
2.

Exposure-Response-Based Product Profile-Driven Clinical Utility Index for Ipatasertib Dose Selection in Prostate Cancer.

Zhu R, Poland B, Wada R, Liu Q, Musib L, Maslyar D, Cho E, Yu W, Ma H, Jin JY, Budha N.

CPT Pharmacometrics Syst Pharmacol. 2019 Apr;8(4):240-248. doi: 10.1002/psp4.12394. Epub 2019 Mar 6.

3.

Correction to: Application of a Novel 'Make and Test in Parallel' Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects.

Cheeti S, Hou HH, Nelson E, Walker H, Chen B, Morley R, Gates M, Musib L, Girish S, Sahasranaman S, Liu L.

Pharm Res. 2018 Oct 26;35(12):244. doi: 10.1007/s11095-018-2529-8.

4.

Application of a Novel 'Make and Test in Parallel' Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects.

Cheeti S, Hou HH, Nelson E, Walker H, Chen B, Morley R, Gates M, Musib L, Girish S, Sahasranaman S, Liu L.

Pharm Res. 2018 Oct 15;35(12):233. doi: 10.1007/s11095-018-2516-0. Erratum in: Pharm Res. 2018 Oct 26;35(12):244.

5.

Association of body-mass index and outcomes in patients with metastatic melanoma treated with targeted therapy, immunotherapy, or chemotherapy: a retrospective, multicohort analysis.

McQuade JL, Daniel CR, Hess KR, Mak C, Wang DY, Rai RR, Park JJ, Haydu LE, Spencer C, Wongchenko M, Lane S, Lee DY, Kaper M, McKean M, Beckermann KE, Rubinstein SM, Rooney I, Musib L, Budha N, Hsu J, Nowicki TS, Avila A, Haas T, Puligandla M, Lee S, Fang S, Wargo JA, Gershenwald JE, Lee JE, Hwu P, Chapman PB, Sosman JA, Schadendorf D, Grob JJ, Flaherty KT, Walker D, Yan Y, McKenna E, Legos JJ, Carlino MS, Ribas A, Kirkwood JM, Long GV, Johnson DB, Menzies AM, Davies MA.

Lancet Oncol. 2018 Mar;19(3):310-322. doi: 10.1016/S1470-2045(18)30078-0. Epub 2018 Feb 12.

6.

Pediatric Dose Selection and Utility of PBPK in Determining Dose.

Templeton IE, Jones NS, Musib L.

AAPS J. 2018 Feb 13;20(2):31. doi: 10.1208/s12248-018-0187-8. Review.

PMID:
29441439
7.

A First-in-Human Phase I Study of the ATP-Competitive AKT Inhibitor Ipatasertib Demonstrates Robust and Safe Targeting of AKT in Patients with Solid Tumors.

Saura C, Roda D, Roselló S, Oliveira M, Macarulla T, Pérez-Fidalgo JA, Morales-Barrera R, Sanchis-García JM, Musib L, Budha N, Zhu J, Nannini M, Chan WY, Sanabria Bohórquez SM, Meng RD, Lin K, Yan Y, Patel P, Baselga J, Tabernero J, Cervantes A.

Cancer Discov. 2017 Jan;7(1):102-113. doi: 10.1158/2159-8290.CD-16-0512. Epub 2016 Nov 21. Erratum in: Cancer Discov. 2018 Nov;8(11):1490.

8.

Evaluation of Cytochrome P450 3A4-Mediated Drug-Drug Interaction Potential for Cobimetinib Using Physiologically Based Pharmacokinetic Modeling and Simulation.

Budha NR, Ji T, Musib L, Eppler S, Dresser M, Chen Y, Jin JY.

Clin Pharmacokinet. 2016 Nov;55(11):1435-1445.

PMID:
27225997
9.

A survey of new oncology drug approvals in the USA from 2010 to 2015: a focus on optimal dose and related postmarketing activities.

Lu D, Lu T, Stroh M, Graham RA, Agarwal P, Musib L, Li CC, Lum BL, Joshi A.

Cancer Chemother Pharmacol. 2016 Mar;77(3):459-76. doi: 10.1007/s00280-015-2931-4. Epub 2016 Jan 25. Review.

10.

Absorption, Metabolism, Excretion, and the Contribution of Intestinal Metabolism to the Oral Disposition of [14C]Cobimetinib, a MEK Inhibitor, in Humans.

Takahashi RH, Choo EF, Ma S, Wong S, Halladay J, Deng Y, Rooney I, Gates M, Hop CE, Khojasteh SC, Dresser MJ, Musib L.

Drug Metab Dispos. 2016 Jan;44(1):28-39. doi: 10.1124/dmd.115.066282. Epub 2015 Oct 8.

PMID:
26451002
11.

Population pharmacokinetics and dosing implications for cobimetinib in patients with solid tumors.

Han K, Jin JY, Marchand M, Eppler S, Choong N, Hack SP, Tikoo N, Bruno R, Dresser M, Musib L, Budha NR.

Cancer Chemother Pharmacol. 2015 Nov;76(5):917-24. doi: 10.1007/s00280-015-2862-0. Epub 2015 Sep 13.

PMID:
26365290
12.

Effects of enzastaurin and its metabolites on the QT interval in cancer patients.

Welch PA, Ng WT, Darstein CL, Musib L, Lesimple T.

J Clin Pharmacol. 2016 Jan;56(1):101-8. doi: 10.1002/jcph.573. Epub 2015 Aug 17.

PMID:
26096682
13.

MEK inhibitors beyond monotherapy: current and future development.

Templeton IE, Musib L.

Curr Opin Pharmacol. 2015 Aug;23:61-7. doi: 10.1016/j.coph.2015.05.012. Epub 2015 Jun 7. Review.

PMID:
26057212
14.

Determination of cobimetinib in human plasma using protein precipitation extraction and high-performance liquid chromatography coupled to mass spectrometry.

Deng Y, Musib L, Choo E, Chapple M, Burke S, Johnson J, Eppler S, Dean B.

J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Dec 1;972:117-23. doi: 10.1016/j.jchromb.2014.09.034. Epub 2014 Oct 7.

PMID:
25444546
15.

Combination of vemurafenib and cobimetinib in patients with advanced BRAF(V600)-mutated melanoma: a phase 1b study.

Ribas A, Gonzalez R, Pavlick A, Hamid O, Gajewski TF, Daud A, Flaherty L, Logan T, Chmielowski B, Lewis K, Kee D, Boasberg P, Yin M, Chan I, Musib L, Choong N, Puzanov I, McArthur GA.

Lancet Oncol. 2014 Aug;15(9):954-65. doi: 10.1016/S1470-2045(14)70301-8. Epub 2014 Jul 15. Erratum in: Lancet Oncol. 2014 Sep;15(10):417.

PMID:
25037139
16.

Absolute bioavailability and effect of formulation change, food, or elevated pH with rabeprazole on cobimetinib absorption in healthy subjects.

Musib L, Choo E, Deng Y, Eppler S, Rooney I, Chan IT, Dresser MJ.

Mol Pharm. 2013 Nov 4;10(11):4046-54. doi: 10.1021/mp400383x. Epub 2013 Sep 30.

PMID:
24010577
17.

A phase II multicenter study of two different dosages of pemetrexed given in combination with cyclophosphamide as first-line treatment in patients with locally advanced or metastatic breast cancer.

Dittrich C, Solska E, Manikhas A, Eniu A, Tjulandin S, Anghel R, Musib L, Frimodt-Moller B, Liu Y, Krejcy K, Láng I.

Cancer Invest. 2012 May;30(4):309-16. doi: 10.3109/07357907.2012.657812. Epub 2012 Apr 2.

PMID:
22468806
18.

Steady-state carbamazepine pharmacokinetics following oral and stable-labeled intravenous administration in epilepsy patients: effects of race and sex.

Marino SE, Birnbaum AK, Leppik IE, Conway JM, Musib LC, Brundage RC, Ramsay RE, Pennell PB, White JR, Gross CR, Rarick JO, Mishra U, Cloyd JC.

Clin Pharmacol Ther. 2012 Mar;91(3):483-8. doi: 10.1038/clpt.2011.251. Epub 2012 Jan 25.

19.

Enzastaurin plus temozolomide with radiation therapy in glioblastoma multiforme: a phase I study.

Butowski N, Chang SM, Lamborn KR, Polley MY, Parvataneni R, Hristova-Kazmierski M, Musib L, Nicol SJ, Thornton DE, Prados MD.

Neuro Oncol. 2010 Jun;12(6):608-13. doi: 10.1093/neuonc/nop070. Epub 2010 Feb 15.

20.

A phase I/II trial of enzastaurin in patients with recurrent high-grade gliomas.

Kreisl TN, Kotliarova S, Butman JA, Albert PS, Kim L, Musib L, Thornton D, Fine HA.

Neuro Oncol. 2010 Feb;12(2):181-9. doi: 10.1093/neuonc/nop042. Epub 2010 Jan 22.

21.

Phase III study of enzastaurin compared with lomustine in the treatment of recurrent intracranial glioblastoma.

Wick W, Puduvalli VK, Chamberlain MC, van den Bent MJ, Carpentier AF, Cher LM, Mason W, Weller M, Hong S, Musib L, Liepa AM, Thornton DE, Fine HA.

J Clin Oncol. 2010 Mar 1;28(7):1168-74. doi: 10.1200/JCO.2009.23.2595. Epub 2010 Feb 1.

22.

Carboplatin and paclitaxel in combination with oral enzastaurin in advanced ovarian or primary peritoneal cancer: results from a safety lead-in study.

Vergote I, Amant F, Oskay-Oezcelik G, Musib L, Michel AL, Darstein C, Kania M, Bauknecht T, Sehouli J.

Int J Gynecol Cancer. 2009 Dec;19(9):1505-10. doi: 10.1111/IGC.0b013e3181bda1a7.

PMID:
19955926
23.

A window of opportunity phase II study of enzastaurin in chemonaive patients with asymptomatic metastatic colorectal cancer.

Glimelius B, Lahn M, Gawande S, Cleverly A, Darstein C, Musib L, Liu Y, Spindler KL, Frödin JE, Berglund A, Byström P, Qvortrup C, Jakobsen A, Pfeiffer P.

Ann Oncol. 2010 May;21(5):1020-6. doi: 10.1093/annonc/mdp521. Epub 2009 Nov 9.

24.

Phase Ib safety and pharmacokinetic evaluation of daily and twice daily oral enzastaurin in combination with pemetrexed in advanced/metastatic cancer.

Hanauske AR, Lahn M, Musib LC, Weigang-Köhler K, Yilmaz E, Graefe T, Kuenen B, Thornton D, McNealy P, Giaccone G.

Ann Oncol. 2009 Sep;20(9):1565-75. doi: 10.1093/annonc/mdp049. Epub 2009 Jun 1.

25.

A phase I trial of enzastaurin in patients with recurrent gliomas.

Kreisl TN, Kim L, Moore K, Duic P, Kotliarova S, Walling J, Musib L, Thornton D, Albert PS, Fine HA.

Clin Cancer Res. 2009 May 15;15(10):3617-23. doi: 10.1158/1078-0432.CCR-08-3071. Epub 2009 May 5.

26.

Safety of an IV formulation of carbamazepine.

Conway JM, White JR, Birnbaum AK, Eugene Ramsay R, Pennell PB, Rarick JO, Musib L, Leppik IE, Cloyd JC.

Epilepsy Res. 2009 Apr;84(2-3):242-4. doi: 10.1016/j.eplepsyres.2009.01.013. Epub 2009 Mar 18.

27.

Phase I and pharmacokinetic study of pemetrexed plus cisplatin in chemonaive patients with locally advanced or metastatic malignant pleural mesothelioma or non-small cell lung cancer.

Dickgreber NJ, Fink TH, Latz JE, Hossain AM, Musib LC, Thomas M.

Clin Cancer Res. 2009 Jan 1;15(1):382-9. doi: 10.1158/1078-0432.CCR-08-0128.

28.

Pharmacokinetic evaluation of platinum derived from cisplatin administered alone and with pemetrexed in head and neck cancer patients.

Specenier PM, Ciuleanu T, Latz JE, Musib LC, Darstein CL, Vermorken JB.

Cancer Chemother Pharmacol. 2009 Jul;64(2):233-41. doi: 10.1007/s00280-008-0853-0. Epub 2008 Nov 15.

PMID:
19011858
29.

Pemetrexed combined with paclitaxel: a dose-finding study evaluating three schedules in solid tumors.

Hanauske AR, Dumez H, Piccart M, Yilmaz E, Graefe T, Gil T, Simms L, Musib L, Awada A.

Invest New Drugs. 2009 Aug;27(4):356-65. doi: 10.1007/s10637-008-9193-5. Epub 2008 Oct 28.

PMID:
18956139
30.

Phenytoin half-life and clearance during maintenance therapy in adults and elderly patients with epilepsy.

Ahn JE, Cloyd JC, Brundage RC, Marino SE, Conway JM, Ramsay RE, White JR, Musib LC, Rarick JO, Birnbaum AK, Leppik IE.

Neurology. 2008 Jul 1;71(1):38-43. doi: 10.1212/01.wnl.0000316392.55784.57.

PMID:
18591503
31.

Enzastaurin, an oral serine/threonine kinase inhibitor, as second- or third-line therapy of non-small-cell lung cancer.

Oh Y, Herbst RS, Burris H, Cleverly A, Musib L, Lahn M, Bepler G.

J Clin Oncol. 2008 Mar 1;26(7):1135-41. doi: 10.1200/JCO.2007.14.3685.

PMID:
18309949
32.

A phase I safety, tolerability, and pharmacokinetic study of enzastaurin combined with capecitabine in patients with advanced solid tumors.

Camidge DR, Gail Eckhardt S, Gore L, O'Bryant CL, Leong S, Basche M, Holden SN, Musib L, Baldwin J, Darstein C, Thornton D, Finn RS, Britten CD.

Anticancer Drugs. 2008 Jan;19(1):77-84.

PMID:
18043132
33.
34.

Phase I pharmacokinetic and pharmacodynamic study of the oral protein kinase C beta-inhibitor enzastaurin in combination with gemcitabine and cisplatin in patients with advanced cancer.

Rademaker-Lakhai JM, Beerepoot LV, Mehra N, Radema SA, van Maanen R, Vermaat JS, Witteveen EO, Visseren-Grul CM, Musib L, Enas N, van Hal G, Beijnen JH, Schellens JH, Voest EE.

Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4474-81.

35.

Phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory diffuse large B-cell lymphoma.

Robertson MJ, Kahl BS, Vose JM, de Vos S, Laughlin M, Flynn PJ, Rowland K, Cruz JC, Goldberg SL, Musib L, Darstein C, Enas N, Kutok JL, Aster JC, Neuberg D, Savage KJ, LaCasce A, Thornton D, Slapak CA, Shipp MA.

J Clin Oncol. 2007 May 1;25(13):1741-6. Epub 2007 Mar 26.

PMID:
17389337
36.

Phase I dose escalation and pharmacokinetic study of enzastaurin, an oral protein kinase C beta inhibitor, in patients with advanced cancer.

Carducci MA, Musib L, Kies MS, Pili R, Truong M, Brahmer JR, Cole P, Sullivan R, Riddle J, Schmidt J, Enas N, Sinha V, Thornton DE, Herbst RS.

J Clin Oncol. 2006 Sep 1;24(25):4092-9.

PMID:
16943527
37.

Development and validation of a drug activity biomarker that shows target inhibition in cancer patients receiving enzastaurin, a novel protein kinase C-beta inhibitor.

Green LJ, Marder P, Ray C, Cook CA, Jaken S, Musib LC, Herbst RS, Carducci M, Britten CD, Basche M, Eckhardt SG, Thornton D.

Clin Cancer Res. 2006 Jun 1;12(11 Pt 1):3408-15.

38.

The protein kinase Cbeta-selective inhibitor, Enzastaurin (LY317615.HCl), suppresses signaling through the AKT pathway, induces apoptosis, and suppresses growth of human colon cancer and glioblastoma xenografts.

Graff JR, McNulty AM, Hanna KR, Konicek BW, Lynch RL, Bailey SN, Banks C, Capen A, Goode R, Lewis JE, Sams L, Huss KL, Campbell RM, Iversen PW, Neubauer BL, Brown TJ, Musib L, Geeganage S, Thornton D.

Cancer Res. 2005 Aug 15;65(16):7462-9.

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