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Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.

Thanarajasingam G, Minasian LM, Baron F, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Krauss A, Kwong YL, Little RF, Mahon FX, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Rule S, Sloan J, Sonneveld P, Thompson CA, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Wintrich S, Seymour JF, Habermann TM.

Lancet Haematol. 2018 Jun 12. pii: S2352-3026(18)30051-6. doi: 10.1016/S2352-3026(18)30051-6. [Epub ahead of print] Review.


Triapine Radiochemotherapy in Advanced Stage Cervical Cancer.

Kunos CA, Ivy SP.

Front Oncol. 2018 May 7;8:149. doi: 10.3389/fonc.2018.00149. eCollection 2018.


Early changes in glioblastoma metabolism measured by MR spectroscopic imaging during combination of anti-angiogenic cediranib and chemoradiation therapy are associated with survival.

Andronesi OC, Esmaeili M, Borra RJH, Emblem K, Gerstner ER, Pinho MC, Plotkin SR, Chi AS, Eichler AF, Dietrich J, Ivy SP, Wen PY, Duda DG, Jain R, Rosen BR, Sorensen GA, Batchelor TT.

NPJ Precis Oncol. 2017;1. pii: 20. doi: 10.1038/s41698-017-0020-3. Epub 2017 Jun 12.


The HRD Decision-Which PARP Inhibitor to Use for Whom and When.

Kohn EC, Lee JM, Ivy SP.

Clin Cancer Res. 2017 Dec 1;23(23):7155-7157. doi: 10.1158/1078-0432.CCR-17-2186. Epub 2017 Oct 3.


Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Minimum Age Working Group.

Gore L, Ivy SP, Balis FM, Rubin E, Thornton K, Donoghue M, Roberts S, Bruinooge S, Ersek J, Goodman N, Schenkel C, Reaman G.

J Clin Oncol. 2017 Nov 20;35(33):3781-3787. doi: 10.1200/JCO.2017.74.4144. Epub 2017 Oct 2.


LC-MS/MS assay for the quantitation of the ribonucleotide reductase inhibitor triapine in human plasma.

Matsumoto J, Kiesel BF, Parise RA, Guo J, Taylor S, Huang M, Eiseman JL, Ivy SP, Kunos C, Chu E, Beumer JH.

J Pharm Biomed Anal. 2017 Nov 30;146:154-160. doi: 10.1016/j.jpba.2017.08.036. Epub 2017 Aug 31.


From Famine to Feast: Developing Early-Phase Combination Immunotherapy Trials Wisely.

Day D, Monjazeb AM, Sharon E, Ivy SP, Rubin EH, Rosner GL, Butler MO.

Clin Cancer Res. 2017 Sep 1;23(17):4980-4991. doi: 10.1158/1078-0432.CCR-16-3064.


Challenges and Opportunities in Adapting Clinical Trial Design for Immunotherapies.

Siu LL, Ivy SP, Dixon EL, Gravell AE, Reeves SA, Rosner GL.

Clin Cancer Res. 2017 Sep 1;23(17):4950-4958. doi: 10.1158/1078-0432.CCR-16-3079.


The 'Pushmi-Pullyu' of DNA REPAIR: Clinical Synthetic Lethality.

Ivy SP, de Bono J, Kohn EC.

Trends Cancer. 2016 Nov;2(11):646-656. doi: 10.1016/j.trecan.2016.10.014. Epub 2016 Nov 23. Review.


Whence High-Grade Serous Ovarian Cancer.

Kohn EC, Ivy SP.

Am Soc Clin Oncol Educ Book. 2017;37:443-448. doi: 10.14694/EDBK_174718. Review.


Drug development and registration: Challenges and opportunities in ovarian cancer.

Ivy SP, Kohn EC.

Cancer. 2017 Jul 15;123(14):2597-2599. doi: 10.1002/cncr.30645. Epub 2017 May 12. No abstract available.


Phase I Trial of Triapine-Cisplatin-Paclitaxel Chemotherapy for Advanced Stage or Metastatic Solid Tumor Cancers.

Kunos CA, Chu E, Makower D, Kaubisch A, Sznol M, Ivy SP.

Front Oncol. 2017 Apr 4;7:62. doi: 10.3389/fonc.2017.00062. eCollection 2017.


Tissue Acquisition in Clinical Trials-Essential for Progress.

Ivy SP, Abrams JS.

J Natl Cancer Inst. 2017 Apr 1;109(4). doi: 10.1093/jnci/djx003. No abstract available.


Phase I trial of daily triapine in combination with cisplatin chemotherapy for advanced-stage malignancies.

Kunos CA, Chu E, Beumer JH, Sznol M, Ivy SP.

Cancer Chemother Pharmacol. 2017 Jan;79(1):201-207. doi: 10.1007/s00280-016-3200-x. Epub 2016 Nov 22.


Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual.

Massett HA, Mishkin G, Rubinstein L, Ivy SP, Denicoff A, Godwin E, DiPiazza K, Bolognese J, Zwiebel JA, Abrams JS.

Clin Cancer Res. 2016 Nov 15;22(22):5408-5416. doi: 10.1158/1078-0432.CCR-16-0338. Epub 2016 Jul 11. Review.


Confronting the Care Delivery Challenges Arising from Precision Medicine.

Kohn EC, Ivy SP.

Front Oncol. 2016 Apr 27;6:106. doi: 10.3389/fonc.2016.00106. eCollection 2016. Review.


The Effect of Hepatic Impairment on Outcomes in Phase I Clinical Trials in Cancer Subjects.

Mansfield AS, Rudek MA, Vulih D, Smith GL, Harris PJ, Ivy SP; NCI Organ Dysfunction Working Group.

Clin Cancer Res. 2016 Nov 15;22(22):5472-5479. doi: 10.1158/1078-0432.CCR-16-0449. Epub 2016 May 17.


Reply to V. Launay-Vacher, T. Shimokata et al, and C. Porta et al.

Beumer JH, Tawbi H, Ivy SP.

J Clin Oncol. 2016 Jul 10;34(20):2430-1. doi: 10.1200/JCO.2016.67.2790. Epub 2016 May 16. No abstract available.


Measuring Toxicity in Phase I Clinical Trials--Letter.

Hyman DM, Eaton A, Ivy SP, Spriggs DR, Iasonos A.

Clin Cancer Res. 2016 Apr 1;22(7):1828. doi: 10.1158/1078-0432.CCR-15-3043. No abstract available.


Beyond the dose-limiting toxicity period: Dermatologic adverse events of patients on phase 1 trials of the Cancer Therapeutics Evaluation Program.

Drilon A, Eaton AA, Schindler K, Gounder MM, Spriggs DR, Harris P, Ivy SP, Iasonos A, Lacouture ME, Hyman DM.

Cancer. 2016 Apr 15;122(8):1228-37. doi: 10.1002/cncr.29918. Epub 2016 Feb 24.


Cediranib, a pan-VEGFR inhibitor, and olaparib, a PARP inhibitor, in combination therapy for high grade serous ovarian cancer.

Ivy SP, Liu JF, Lee JM, Matulonis UA, Kohn EC.

Expert Opin Investig Drugs. 2016;25(5):597-611. doi: 10.1517/13543784.2016.1156857. Epub 2016 Mar 16. Review.


Challenges and Opportunities for Immunotherapies in Gynecologic Cancers.

Lee JM, Ivy SP, Kohn EC.

Oncology (Williston Park). 2016 Jan;30(1):67-9. No abstract available.


Impact of the 2010 Consensus Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee.

Seymour L, Groshen S, Rosner GL, Sullivan DM, Spriggs DR, Reeves S, Gravell A, Ivy SP, Ratain MJ.

Clin Cancer Res. 2015 Nov 15;21(22):5057-63. doi: 10.1158/1078-0432.CCR-15-0035.


Phase I Clinical Trials in Acute Myeloid Leukemia: 23-Year Experience From Cancer Therapy Evaluation Program of the National Cancer Institute.

Zeidner JF, Karp JE, Blackford AL, Foster MC, Dees EC, Smith G, Ivy SP, Harris P.

J Natl Cancer Inst. 2015 Nov 9;108(3). doi: 10.1093/jnci/djv335. Print 2016 Mar.


Severe hepatic dysfunction is associated with venous thromboembolic events in phase 1 clinical trials.

Mansfield AS, Tafur AJ, Vulih D, Smith GL, Harris PJ, Ivy SP.

Thromb Res. 2015 Dec;136(6):1169-73. doi: 10.1016/j.thromres.2015.10.024. Epub 2015 Oct 20.


Effect of Renal Dysfunction on Toxicity in Three Decades of Cancer Therapy Evaluation Program-Sponsored Single-Agent Phase I Studies.

Beumer JH, Ding F, Tawbi H, Lin Y, Viluh D, Chatterjee I, Rinker M, Chow SL, Ivy SP.

J Clin Oncol. 2016 Jan 10;34(2):110-6. doi: 10.1200/JCO.2014.59.7302. Epub 2015 Sep 21.


The National Cancer Institute's Experimental Therapeutics Clinical Trials Network.

Ivy SP.

Clin Adv Hematol Oncol. 2015 Mar;13(3):144-6. No abstract available.


Toxicity Attribution in Phase I Trials: Evaluating the Effect of Dose on the Frequency of Related and Unrelated Toxicities.

Eaton A, Iasonos A, Gounder MM, Pamer EG, Drilon A, Vulih D, Smith GL, Ivy SP, Spriggs DR, Hyman DM.

Clin Cancer Res. 2016 Feb 1;22(3):553-9. doi: 10.1158/1078-0432.CCR-15-0339. Epub 2015 Aug 31.


Evaluation of the Safety and Benefit of Phase I Oncology Trials for Patients With Primary CNS Tumors.

Gounder MM, Nayak L, Sahebjam S, Muzikansky A, Sanchez AJ, Desideri S, Ye X, Ivy SP, Nabors LB, Prados M, Grossman S, DeAngelis LM, Wen PY.

J Clin Oncol. 2015 Oct 1;33(28):3186-92. doi: 10.1200/JCO.2015.61.1525. Epub 2015 Aug 17.


Ovarian Cancer Survival and Chemotherapy Dosing, Body Mass Index, and Body Surface Area : Are We There Yet?

Ivy SP, Beumer JH.

JAMA Oncol. 2015 Sep;1(6):732-3. doi: 10.1001/jamaoncol.2015.1926. No abstract available.


CECs and IL-8 Have Prognostic and Predictive Utility in Patients with Recurrent Platinum-Sensitive Ovarian Cancer: Biomarker Correlates from the Randomized Phase-2 Trial of Olaparib and Cediranib Compared with Olaparib in Recurrent Platinum-Sensitive Ovarian Cancer.

Lee JM, Trepel JB, Choyke P, Cao L, Sissung T, Houston N, Yu M, Figg WD, Turkbey IB, Steinberg SM, Lee MJ, Ivy SP, Liu JF, Matulonis UA, Kohn EC.

Front Oncol. 2015 Jun 1;5:123. doi: 10.3389/fonc.2015.00123. eCollection 2015.


A phase 2 study of cediranib in recurrent or persistent ovarian, peritoneal or fallopian tube cancer: a trial of the Princess Margaret, Chicago and California Phase II Consortia.

Hirte H, Lheureux S, Fleming GF, Sugimoto A, Morgan R, Biagi J, Wang L, McGill S, Ivy SP, Oza AM.

Gynecol Oncol. 2015 Jul;138(1):55-61. doi: 10.1016/j.ygyno.2015.04.009. Epub 2015 Apr 17.


Targeting Notch, Hedgehog, and Wnt pathways in cancer stem cells: clinical update.

Takebe N, Miele L, Harris PJ, Jeong W, Bando H, Kahn M, Yang SX, Ivy SP.

Nat Rev Clin Oncol. 2015 Aug;12(8):445-64. doi: 10.1038/nrclinonc.2015.61. Epub 2015 Apr 7. Review.


A phase II study of single-agent RO4929097, a gamma-secretase inhibitor of Notch signaling, in patients with recurrent platinum-resistant epithelial ovarian cancer: A study of the Princess Margaret, Chicago and California phase II consortia.

Diaz-Padilla I, Wilson MK, Clarke BA, Hirte HW, Welch SA, Mackay HJ, Biagi JJ, Reedijk M, Weberpals JI, Fleming GF, Wang L, Liu G, Zhou C, Blattler C, Ivy SP, Oza AM.

Gynecol Oncol. 2015 May;137(2):216-22. doi: 10.1016/j.ygyno.2015.03.005. Epub 2015 Mar 11.


Predictors of early treatment discontinuation in patients enrolled on Phase I oncology trials.

Hyman DM, Eaton AA, Gounder MM, Pamer EG, Pettiford J, Carvajal RD, Ivy SP, Iasonos A, Spriggs DR.

Oncotarget. 2015 Aug 7;6(22):19316-27.


Evaluation of second-line and subsequent targeted therapies in metastatic renal cell cancer (mRCC) patients treated with first-line cediranib.

Richter S, Seah JA, Pond GR, Gan HK, Mackenzie MJ, Hotte SJ, Mukherjee SD, Murray N, Kollmannsberger C, Heng D, Haider MA, Halford R, Ivy SP, Moore MJ, Sridhar SS.

Can Urol Assoc J. 2014 Nov;8(11-12):398-402. doi: 10.5489/cuaj.2426.


Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomised phase 2 study.

Liu JF, Barry WT, Birrer M, Lee JM, Buckanovich RJ, Fleming GF, Rimel B, Buss MK, Nattam S, Hurteau J, Luo W, Quy P, Whalen C, Obermayer L, Lee H, Winer EP, Kohn EC, Ivy SP, Matulonis UA.

Lancet Oncol. 2014 Oct;15(11):1207-14. doi: 10.1016/S1470-2045(14)70391-2. Epub 2014 Sep 10.


Design of phase I combination trials: recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee.

Paller CJ, Bradbury PA, Ivy SP, Seymour L, LoRusso PM, Baker L, Rubinstein L, Huang E, Collyar D, Groshen S, Reeves S, Ellis LM, Sargent DJ, Rosner GL, LeBlanc ML, Ratain MJ.

Clin Cancer Res. 2014 Aug 15;20(16):4210-7. doi: 10.1158/1078-0432.CCR-14-0521. Review.


Reply to M. Voskoboynik et al.

Hyman DM, Eaton AA, Gounder MM, Ivy SP, Iasonos A, Spriggs DR.

J Clin Oncol. 2014 Oct 1;32(28):3199-200. doi: 10.1200/JCO.2014.56.5762. Epub 2014 Jul 28. No abstract available.


The role of age on dose-limiting toxicities in phase I dose-escalation trials.

Schwandt A, Harris PJ, Hunsberger S, Deleporte A, Smith GL, Vulih D, Anderson BD, Ivy SP.

Clin Cancer Res. 2014 Sep 15;20(18):4768-75. doi: 10.1158/1078-0432.CCR-14-0866. Epub 2014 Jul 15.


Historical controls for metastatic pancreatic cancer: benchmarks for planning and analyzing single-arm phase II trials.

Philip PA, Chansky K, LeBlanc M, Rubinstein L, Seymour L, Ivy SP, Alberts SR, Catalano PJ, Crowley J.

Clin Cancer Res. 2014 Aug 15;20(16):4176-85. doi: 10.1158/1078-0432.CCR-13-2024. Epub 2014 Jun 9.


A randomized phase II study of cediranib alone versus cediranib in combination with dasatinib in docetaxel resistant, castration resistant prostate cancer patients.

Spreafico A, Chi KN, Sridhar SS, Smith DC, Carducci MA, Kavsak P, Wong TS, Wang L, Ivy SP, Mukherjee SD, Kollmannsberger CK, Sukhai MA, Takebe N, Kamel-Reid S, Siu LL, Hotte SJ.

Invest New Drugs. 2014 Oct;32(5):1005-16. doi: 10.1007/s10637-014-0106-5. Epub 2014 May 3.


Sunitinib malate in patients with intermediate-2 or high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia.

Yee KW, Storring JM, Buckstein R, Wells RA, Xenocostas A, Kovacs MJ, Howson-Jan K, Wang ES, Battista K, Wang L, Oza AM, Ivy SP, Schuh AC.

Leuk Lymphoma. 2014 Nov;55(11):2669-71. doi: 10.3109/10428194.2014.900763. Epub 2014 Apr 22. No abstract available.


A phase 1/pharmacokinetic study of sunitinib in combination with highly active antiretroviral therapy in human immunodeficiency virus-positive patients with cancer: AIDS Malignancy Consortium trial AMC 061.

Rudek MA, Moore PC, Mitsuyasu RT, Dezube BJ, Aboulafia D, Gerecitano J, Sullivan R, Cianfrocca ME, Henry DH, Ratner L, Haigentz M Jr, Dowlati A, Little RF, Ivy SP, Deeken JF.

Cancer. 2014 Apr 15;120(8):1194-202. doi: 10.1002/cncr.28554. Epub 2014 Jan 28.


A phase II trial of sequential ribonucleotide reductase inhibition in aggressive myeloproliferative neoplasms.

Zeidner JF, Karp JE, Blackford AL, Smith BD, Gojo I, Gore SD, Levis MJ, Carraway HE, Greer JM, Ivy SP, Pratz KW, McDevitt MA.

Haematologica. 2014 Apr;99(4):672-8. doi: 10.3324/haematol.2013.097246. Epub 2013 Dec 20.


Improved tumor oxygenation and survival in glioblastoma patients who show increased blood perfusion after cediranib and chemoradiation.

Batchelor TT, Gerstner ER, Emblem KE, Duda DG, Kalpathy-Cramer J, Snuderl M, Ancukiewicz M, Polaskova P, Pinho MC, Jennings D, Plotkin SR, Chi AS, Eichler AF, Dietrich J, Hochberg FH, Lu-Emerson C, Iafrate AJ, Ivy SP, Rosen BR, Loeffler JS, Wen PY, Sorensen AG, Jain RK.

Proc Natl Acad Sci U S A. 2013 Nov 19;110(47):19059-64. doi: 10.1073/pnas.1318022110. Epub 2013 Nov 4.


A phase I study of the combination of ro4929097 and cediranib in patients with advanced solid tumours (PJC-004/NCI 8503).

Sahebjam S, Bedard PL, Castonguay V, Chen Z, Reedijk M, Liu G, Cohen B, Zhang WJ, Clarke B, Zhang T, Kamel-Reid S, Chen H, Ivy SP, Razak AR, Oza AM, Chen EX, Hirte HW, McGarrity A, Wang L, Siu LL, Hotte SJ.

Br J Cancer. 2013 Aug 20;109(4):943-9. doi: 10.1038/bjc.2013.380. Epub 2013 Jul 18.


A phase Ib combination study of RO4929097, a gamma-secretase inhibitor, and temsirolimus in patients with advanced solid tumors.

Diaz-Padilla I, Hirte H, Oza AM, Clarke BA, Cohen B, Reedjik M, Zhang T, Kamel-Reid S, Ivy SP, Hotte SJ, Razak AA, Chen EX, Brana I, Wizemann M, Wang L, Siu LL, Bedard PL.

Invest New Drugs. 2013 Oct;31(5):1182-91. doi: 10.1007/s10637-013-0001-5. Epub 2013 Jul 17.


Developing standards for breakthrough therapy designation in oncology.

Horning SJ, Haber DA, Selig WK, Ivy SP, Roberts SA, Allen JD, Sigal EV, Sawyers CL.

Clin Cancer Res. 2013 Aug 15;19(16):4297-304. doi: 10.1158/1078-0432.CCR-13-0523. Epub 2013 May 29.


Phase I study of pazopanib in patients with advanced solid tumors and hepatic dysfunction: a National Cancer Institute Organ Dysfunction Working Group study.

Shibata SI, Chung V, Synold TW, Longmate JA, Suttle AB, Ottesen LH, Lenz HJ, Kummar S, Harvey RD, Hamilton AL, O'Neil BH, Sarantopoulos J, LoRusso P, Rudek MA, Dowlati A, Mulkerin DL, Belani CP, Gandhi L, Lau SC, Ivy SP, Newman EM.

Clin Cancer Res. 2013 Jul 1;19(13):3631-9. doi: 10.1158/1078-0432.CCR-12-3214. Epub 2013 May 7.

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