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Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer.
Socinski MA, Waller CF, Idris T, Bondarenko I, Luft A, Beckmann K, Vishweswaramurthy A, Loganathan S, Donnelly C, Hummel MA, Shapiro R, Woods M, Rao A, Nayak VG, Ranganna G, Barve A. Socinski MA, et al. Among authors: waller cf. Ther Adv Med Oncol. 2021 Nov 18;13:17588359211045845. doi: 10.1177/17588359211045845. eCollection 2021. Ther Adv Med Oncol. 2021. PMID: 34819997 Free PMC article.
A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.
Waller CF, Tiessen RG, Lawrence TE, Shaw A, Liu MS, Sharma R, Baczkowski M, Kothekar MA, Micales CE, Barve A, Ranganna GM, Pennella EJ. Waller CF, et al. J Cancer Res Clin Oncol. 2018 Jun;144(6):1087-1095. doi: 10.1007/s00432-018-2643-3. Epub 2018 Apr 18. J Cancer Res Clin Oncol. 2018. PMID: 29671069 Clinical Trial.
Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia.
Waller CF, Ranganna GM, Pennella EJ, Blakeley C, Bronchud MH, Mattano LA Jr, Berzoy O, Voitko N, Shparyk Y, Lytvyn I, Rusyn A, Popov V, Láng I, Beckmann K, Sharma R, Baczkowski M, Kothekar M, Barve A. Waller CF, et al. Ann Hematol. 2019 May;98(5):1217-1224. doi: 10.1007/s00277-019-03639-5. Epub 2019 Mar 1. Ann Hematol. 2019. PMID: 30824956 Free PMC article. Clinical Trial.
Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer.
Rugo HS, Pennella EJ, Gopalakrishnan U, Hernandez-Bronchud M, Herson J, Koch HF, Loganathan S, Deodhar S, Marwah A, Manikhas A, Bondarenko I, Mukhametshina G, Nemsadze G, Parra JD, Abesamis-Tiambeng MLT, Baramidze K, Akewanlop C, Vynnychenko I, Sriuranpong V, Mamillapalli G, Roy S, Yanez Ruiz EP, Barve A, Fuentes-Alburo A, Waller CF. Rugo HS, et al. Among authors: waller cf. Breast Cancer Res Treat. 2021 Jul;188(2):369-377. doi: 10.1007/s10549-021-06197-5. Epub 2021 Jun 14. Breast Cancer Res Treat. 2021. PMID: 34125340 Free PMC article. Clinical Trial.
Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Randomized Clinical Trial.
Rugo HS, Barve A, Waller CF, Hernandez-Bronchud M, Herson J, Yuan J, Sharma R, Baczkowski M, Kothekar M, Loganathan S, Manikhas A, Bondarenko I, Mukhametshina G, Nemsadze G, Parra JD, Abesamis-Tiambeng ML, Baramidze K, Akewanlop C, Vynnychenko I, Sriuranpong V, Mamillapalli G, Ray S, Yanez Ruiz EP, Pennella E; Heritage Study Investigators. Rugo HS, et al. Among authors: waller cf. JAMA. 2017 Jan 3;317(1):37-47. doi: 10.1001/jama.2016.18305. JAMA. 2017. PMID: 27918780 Clinical Trial.
Correlation between week 24 trastuzumab-dkst response and week 48 progression-free survival: the HERITAGE trial.
Rugo HS, Pennella EJ, Gopalakrishnan U, Hernandez-Bronchud M, Herson J, Koch HF, Loganathan S, Deodhar S, Marwah A, Manikhas A, Bondarenko I, Parra JD, Abesamis-Tiambeng MLT, Akewanlop C, Vynnychenko I, Sriuranpong V, Roy S, Yanez Ruiz EP, Barve A, Waller CF. Rugo HS, et al. Among authors: waller cf. Breast. 2021 Aug;58:18-26. doi: 10.1016/j.breast.2021.03.009. Epub 2021 Apr 1. Breast. 2021. PMID: 33892316 Free PMC article. Clinical Trial.
An open-label, multicenter, randomized phase Ib/II study of eribulin mesylate administered in combination with pemetrexed versus pemetrexed alone as second-line therapy in patients with advanced nonsquamous non-small-cell lung cancer.
Waller CF, Vynnychenko I, Bondarenko I, Shparyk Y, Hodge JP, Freeman A, Huber B, Lieberman R, Shelton MJ, Dave H. Waller CF, et al. Clin Lung Cancer. 2015 Mar;16(2):92-9. doi: 10.1016/j.cllc.2014.10.001. Epub 2014 Oct 15. Clin Lung Cancer. 2015. PMID: 25458558 Clinical Trial.
A randomized, multicenter phase II study comparing efficacy, safety and tolerability of two dosing regimens of cisplatin and pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.
Metzenmacher M, Kopp HG, Griesinger F, Reinmuth N, Sebastian M, Serke M, Waller CF, Thomas M, Eggert J, Schmid-Bindert G, Hoiczyk M, Christoph DC, Kimmich M, Deuß B, Seifert S, Held S, Schuler M, Herold T, Breitenbuecher F, Eberhardt WEE. Metzenmacher M, et al. Among authors: waller cf. Ther Adv Med Oncol. 2021 Mar 9;13:1758835921996506. doi: 10.1177/1758835921996506. eCollection 2021. Ther Adv Med Oncol. 2021. PMID: 34104223 Free PMC article.
138 results