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Phase I Study of a Poxviral TRICOM-Based Vaccine Directed Against the Transcription Factor Brachyury.
Heery CR, Palena C, McMahon S, Donahue RN, Lepone LM, Grenga I, Dirmeier U, Cordes L, Marté J, Dahut W, Singh H, Madan RA, Fernando RI, Hamilton DH, Schlom J, Gulley JL. Heery CR, et al. Among authors: singh h. Clin Cancer Res. 2017 Nov 15;23(22):6833-6845. doi: 10.1158/1078-0432.CCR-17-1087. Epub 2017 Aug 30. Clin Cancer Res. 2017. PMID: 28855356 Free PMC article. Clinical Trial.
Clinical and immunologic impact of short-course enzalutamide alone and with immunotherapy in non-metastatic castration sensitive prostate cancer.
Madan RA, Karzai F, Donahue RN, Al-Harthy M, Bilusic M, Rosner II, Singh H, Arlen PM, Theoret MR, Marté JL, Cordes L, Couvillon A, Hankin A, Williams M, Owens H, Lochrin SE, Chau CH, Steinberg S, Figg WD, Dahut W, Schlom J, Gulley JL. Madan RA, et al. Among authors: singh h. J Immunother Cancer. 2021 Mar;9(3):e001556. doi: 10.1136/jitc-2020-001556. J Immunother Cancer. 2021. PMID: 33664086 Free PMC article. Clinical Trial.
Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.
Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson LL, Karesh A, Khin NA, Less JR, Menikoff J, Minasian L, Mitchell SA, Papadopoulos EJ, Piekarz RL, Prohaska KA, Thompson S, Sridhara R, Pazdur R, Kluetz PG. Kim J, et al. Among authors: singh h. Clin Cancer Res. 2018 Apr 15;24(8):1780-1784. doi: 10.1158/1078-0432.CCR-17-2555. Epub 2017 Dec 13. Clin Cancer Res. 2018. PMID: 29237718 Review.
U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer.
Singh H, Walker AJ, Amiri-Kordestani L, Cheng J, Tang S, Balcazar P, Barnett-Ringgold K, Palmby TR, Cao X, Zheng N, Liu Q, Yu J, Pierce WF, Daniels SR, Sridhara R, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R. Singh H, et al. Clin Cancer Res. 2018 Aug 1;24(15):3486-3491. doi: 10.1158/1078-0432.CCR-17-3628. Epub 2018 Mar 9. Clin Cancer Res. 2018. PMID: 29523624 Clinical Trial.
FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations.
Mathieu LN, Larkins E, Akinboro O, Roy P, Amatya AK, Fiero MH, Mishra-Kalyani PS, Helms WS, Myers CE, Skinner AM, Aungst S, Jin R, Zhao H, Xia H, Zirkelbach JF, Bi Y, Li Y, Liu J, Grimstein M, Zhang X, Woods S, Reece K, Abukhdeir AM, Ghosh S, Philip R, Tang S, Goldberg KB, Pazdur R, Beaver JA, Singh H. Mathieu LN, et al. Among authors: singh h. Clin Cancer Res. 2022 Jan 15;28(2):249-254. doi: 10.1158/1078-0432.CCR-21-1566. Epub 2021 Aug 3. Clin Cancer Res. 2022. PMID: 34344795 Review.
FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC.
Nakajima EC, Drezner N, Li X, Mishra-Kalyani PS, Liu Y, Zhao H, Bi Y, Liu J, Rahman A, Wearne E, Ojofeitimi I, Hotaki LT, Spillman D, Pazdur R, Beaver JA, Singh H. Nakajima EC, et al. Among authors: singh h. Clin Cancer Res. 2022 Apr 14;28(8):1482-1486. doi: 10.1158/1078-0432.CCR-21-3074. Clin Cancer Res. 2022. PMID: 34903582 Free PMC article.
U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma.
Singh H, Brave M, Beaver JA, Cheng J, Tang S, Zahalka E, Palmby TR, Venugopal R, Song P, Liu Q, Liu C, Yu J, Chen XH, Wang X, Wang Y, Kluetz PG, Daniels SR, Papadopoulos EJ, Sridhara R, McKee AE, Ibrahim A, Kim G, Pazdur R. Singh H, et al. Clin Cancer Res. 2017 Jan 15;23(2):330-335. doi: 10.1158/1078-0432.CCR-16-1073. Epub 2016 Oct 28. Clin Cancer Res. 2017. PMID: 27793960 Clinical Trial.
Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies.
Brewer JR, Chang E, Agrawal S, Singh H, Suzman DL, Xu J, Weinstock C, Fernandes LL, Cheng J, Zhang L, Xie D, Goldberg KB, Bloomquist EW, Tang S, Sridhara R, Theoret MR, Pazdur R, Ibrahim A, Beaver JA. Brewer JR, et al. Among authors: singh h. Clin Cancer Res. 2020 Dec 15;26(24):6406-6411. doi: 10.1158/1078-0432.CCR-19-4229. Epub 2020 Jul 30. Clin Cancer Res. 2020. PMID: 32732222
FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions.
Bradford D, Larkins E, Mushti SL, Rodriguez L, Skinner AM, Helms WS, Price LSL, Zirkelbach JF, Li Y, Liu J, Charlab R, Turcu FR, Liang D, Ghosh S, Roscoe D, Philip R, Zack-Taylor A, Tang S, Kluetz PG, Beaver JA, Pazdur R, Theoret MR, Singh H. Bradford D, et al. Among authors: singh h. Clin Cancer Res. 2021 Apr 15;27(8):2130-2135. doi: 10.1158/1078-0432.CCR-20-3558. Epub 2020 Nov 25. Clin Cancer Res. 2021. PMID: 33239432
FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer.
Singh S, Jaigirdar AA, Mulkey F, Cheng J, Hamed SS, Li Y, Liu J, Zhao H, Goheer A, Helms WS, Wang X, Agarwal R, Pragani R, Korsah K, Tang S, Leighton J, Rahman A, Beaver JA, Pazdur R, Theoret MR, Singh H. Singh S, et al. Among authors: singh h. Clin Cancer Res. 2021 May 1;27(9):2378-2382. doi: 10.1158/1078-0432.CCR-20-3901. Epub 2020 Dec 7. Clin Cancer Res. 2021. PMID: 33288660 Free PMC article.
7,705 results