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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: kluetz pg. 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.
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary.
Kluetz PG, Ning YM, Maher VE, Zhang L, Tang S, Ghosh D, Aziz R, Palmby T, Pfuma E, Zirkelbach JF, Mehrotra N, Tilley A, Sridhara R, Ibrahim A, Justice R, Pazdur R. Kluetz PG, et al. Clin Cancer Res. 2013 Dec 15;19(24):6650-6. doi: 10.1158/1078-0432.CCR-13-2134. Epub 2013 Oct 22. Clin Cancer Res. 2013. PMID: 24150234 Clinical Trial.
Radium Ra 223 dichloride injection: U.S. Food and Drug Administration drug approval summary.
Kluetz PG, Pierce W, Maher VE, Zhang H, Tang S, Song P, Liu Q, Haber MT, Leutzinger EE, Al-Hakim A, Chen W, Palmby T, Alebachew E, Sridhara R, Ibrahim A, Justice R, Pazdur R. Kluetz PG, et al. Clin Cancer Res. 2014 Jan 1;20(1):9-14. doi: 10.1158/1078-0432.CCR-13-2665. Epub 2013 Nov 4. Clin Cancer Res. 2014. PMID: 24190979 Clinical Trial.
Clinical trial design for the development of new therapies for nonmuscle-invasive bladder cancer: report of a Food and Drug Administration and American Urological Association public workshop.
Jarow JP, Lerner SP, Kluetz PG, Liu K, Sridhara R, Bajorin D, Chang S, Dinney CP, Groshen S, Morton RA, O'Donnell M, Quale DZ, Schoenberg M, Seigne J, Vikram B. Jarow JP, et al. Among authors: kluetz pg. Urology. 2014 Feb;83(2):262-4. doi: 10.1016/j.urology.2013.10.030. Epub 2013 Dec 12. Urology. 2014. PMID: 24332121
Drug and device development for localized prostate cancer: report of a Food and Drug Administration/American Urological Association public workshop.
Jarow JP, Thompson IM, Kluetz PG, Baxley J, Sridhara R, Scardino P, Carroll P, Albertsen P, Carter HB, Brawley O, Sartor O, Sandler H, Kiefert JJ, Morton RA Jr. Jarow JP, et al. Among authors: kluetz pg. Urology. 2014 May;83(5):975-8. doi: 10.1016/j.urology.2013.10.087. Epub 2014 Mar 22. Urology. 2014. PMID: 24661332
Reply by the authors.
Jarow J, Kluetz PG, Lerner SP, Liu K, Sridhara R, Bajorin D, Chang S, Dinney CP, Groshen S, Morton RA, O'Donnell M, Quale DZ, Schoenberg M, Seigne J, Vikram B. Jarow J, et al. Among authors: kluetz pg. Urology. 2014 Aug;84(2):495-6. doi: 10.1016/j.urology.2014.04.004. Urology. 2014. PMID: 25065996 No abstract available.
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. Among authors: kluetz pg. 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.
166 results