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Page 1
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples.
Amatya AK, Fiero MH, Bloomquist EW, Sinha AK, Lemery SJ, Singh H, Ibrahim A, Donoghue M, Fashoyin-Aje LA, de Claro RA, Gormley NJ, Amiri-Kordestani L, Sridhara R, Theoret MR, Kluetz PG, Pazdur R, Beaver JA, Tang S. Amatya AK, et al. Clin Cancer Res. 2021 Nov 1;27(21):5753-5756. doi: 10.1158/1078-0432.CCR-20-4912. Epub 2021 Jun 11. Clin Cancer Res. 2021. PMID: 34117032 Free PMC article. Review.
Drug development: portals of discovery.
Bates SE, Amiri-Kordestani L, Giaccone G. Bates SE, et al. Clin Cancer Res. 2012 Jan 1;18(1):23-32. doi: 10.1158/1078-0432.CCR-11-1001. Clin Cancer Res. 2012. PMID: 22215903
Phase I trial of a new schedule of romidepsin in patients with advanced cancers.
Amiri-Kordestani L, Luchenko V, Peer CJ, Ghafourian K, Reynolds J, Draper D, Frye R, Woo S, Venzon D, Wright J, Skarulis M, Figg WD, Fojo T, Bates SE, Piekarz RL. Amiri-Kordestani L, et al. Clin Cancer Res. 2013 Aug 15;19(16):4499-507. doi: 10.1158/1078-0432.CCR-13-0095. Epub 2013 Jun 11. Clin Cancer Res. 2013. PMID: 23757352 Free PMC article. Clinical Trial.
CNS metastases in breast cancer: old challenge, new frontiers.
Lin NU, Amiri-Kordestani L, Palmieri D, Liewehr DJ, Steeg PS. Lin NU, et al. Clin Cancer Res. 2013 Dec 1;19(23):6404-18. doi: 10.1158/1078-0432.CCR-13-0790. Clin Cancer Res. 2013. PMID: 24298071 Free PMC article. Review.
FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer.
Amiri-Kordestani L, Blumenthal GM, Xu QC, Zhang L, Tang SW, Ha L, Weinberg WC, Chi B, Candau-Chacon R, Hughes P, Russell AM, Miksinski SP, Chen XH, McGuinn WD, Palmby T, Schrieber SJ, Liu Q, Wang J, Song P, Mehrotra N, Skarupa L, Clouse K, Al-Hakim A, Sridhara R, Ibrahim A, Justice R, Pazdur R, Cortazar P. Amiri-Kordestani L, et al. Clin Cancer Res. 2014 Sep 1;20(17):4436-41. doi: 10.1158/1078-0432.CCR-14-0012. Epub 2014 May 30. Clin Cancer Res. 2014. PMID: 24879797 Clinical Trial.
FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.
Beaver JA, Amiri-Kordestani L, Charlab R, Chen W, Palmby T, Tilley A, Zirkelbach JF, Yu J, Liu Q, Zhao L, Crich J, Chen XH, Hughes M, Bloomquist E, Tang S, Sridhara R, Kluetz PG, Kim G, Ibrahim A, Pazdur R, Cortazar P. Beaver JA, et al. Clin Cancer Res. 2015 Nov 1;21(21):4760-6. doi: 10.1158/1078-0432.CCR-15-1185. Epub 2015 Aug 31. Clin Cancer Res. 2015. PMID: 26324739 Review.
FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer.
Walker AJ, Wedam S, Amiri-Kordestani L, Bloomquist E, Tang S, Sridhara R, Chen W, Palmby TR, Fourie Zirkelbach J, Fu W, Liu Q, Tilley A, Kim G, Kluetz PG, McKee AE, Pazdur R. Walker AJ, et al. Clin Cancer Res. 2016 Oct 15;22(20):4968-4972. doi: 10.1158/1078-0432.CCR-16-0493. Epub 2016 Jul 12. Clin Cancer Res. 2016. PMID: 27407089
91 results