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Table representation of search results timeline featuring number of search results per year.

Year Number of Results
1993 5
1994 19
1995 23
1996 37
1997 63
1998 66
1999 61
2000 45
2001 39
2002 35
2003 52
2004 28
2005 44
2006 39
2007 37
2008 33
2009 38
2010 38
2011 38
2012 16
2013 37
2014 26
2015 37
2016 34
2017 28
2018 31
2019 14
2020 1
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885 results
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Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741.
Citron ML, et al. J Clin Oncol 2003 - Clinical Trial. PMID 12668651
PATIENTS AND METHODS: A total of 2,005 female patients were randomly assigned to receive one of the following regimens: (I) sequential A x 4 (doses) --> T x 4 --> C x 4 with doses every 3 weeks, (II) sequential A x 4 --> T x 4 --> C x 4 every 2 weeks with filgrastim, (III) concurrent AC x 4 --> T x 4 every 3 weeks, or (IV) concurrent AC x 4 --> T x 4 every 2 weeks with filgrastim. ...CONCLUSION: Dose density improves clinical outcomes significantly, despite the lower than expected number of events at this time. ...
PATIENTS AND METHODS: A total of 2,005 female patients were randomly assigned to receive one of the following regimens: (I) sequential A x 4 …
NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim
Kirshner JJ, et al. Support Care Cancer 2018 - Clinical Trial. PMID 29147854 Free PMC article.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ; NCT01712009....
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ; NCT01712009....
A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.
Waller CF, et al. J Cancer Res Clin Oncol 2018 - Clinical Trial. PMID 29671069
METHODS: This phase 1, randomized, double-blind, three-way crossover trial in healthy volunteers evaluated the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of the proposed biosimilar, comparing MYL-1401H, reference pegfilgrastim (Neulasta(®), Amgen Inc, Thousand Oaks, CA, USA) sourced from the European Union, and reference pegfilgrastim sourced from the USA. ...
METHODS: This phase 1, randomized, double-blind, three-way crossover trial in healthy volunteers evaluated the pharmacokinetics (PK), …
Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.
Blackwell K, et al. Ann Oncol 2018 - Clinical Trial. PMID 29091995 Free article.
PATIENTS AND METHODS: A total of 218 patients receiving 5 µg/kg/day filgrastim over six chemotherapy cycles were randomised 1: 1: 1: 1 into four arms. ...Adverse events related to filgrastim were reported in 42.1% (switched) versus 39.2% (reference) (all cycles). Musculoskeletal/connective tissue disorders related to filgrastim occurred in 35.5% (switched) versus 39.2% (reference) (all cycles), including bone pain (30.8% versus 33.3%). ...
PATIENTS AND METHODS: A total of 218 patients receiving 5 µg/kg/day filgrastim over six chemotherapy cycles were randomised 1: 1: 1: …
Randomized phase III trial of high-dose-intensity methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) chemotherapy and recombinant human granulocyte colony-stimulating factor versus classic MVAC in advanced urothelial tract tumors: European Organization for Research and Treatment of Cancer Protocol no. 30924.
Sternberg CN, et al. J Clin Oncol 2001 - Clinical Trial. PMID 11352955
PURPOSE: This randomized trial evaluated antitumor activity of and survival asociated with high-dose-intensity chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) plus granulocyte colony-stimulating factor (HD-MVAC) versus MVAC in patients with advanced transitional-cell carcinoma (TCC). ...
PURPOSE: This randomized trial evaluated antitumor activity of and survival asociated with high-dose-intensity chemotherapy with meth …
Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers.
Choi C, et al. Drug Des Devel Ther 2018 - Clinical Trial. PMID 30122896 Free PMC article.
Leucostim(®) is a recombinant filgrastim product tested for biosimilarity with its reference product, Neupogen(®). We conducted a comparative clinical trial of the 2 products. ...CONCLUSION: This study has provided firm clinical evidence that the test filgrastim product is similar to its reference filgrastim product....
Leucostim(®) is a recombinant filgrastim product tested for biosimilarity with its reference product, Neupogen(®). We conducted a com …
Results of a Prospective Randomized, Open-Label, Noninferiority Study of Tbo-Filgrastim (Granix) versus Filgrastim (Neupogen) in Combination with Plerixafor for Autologous Stem Cell Mobilization in Patients with Multiple Myeloma and Non-Hodgkin Lymphoma.
Bhamidipati PK, et al. Biol Blood Marrow Transplant 2017 - Clinical Trial. PMID 28797783 Free article.
We have conducted the first prospective randomized trial comparing the safety and efficacy of tbo-filgrastim in combination with plerixafor with that of filgrastim in combination with plerixafor for stem cell mobilization in patients with MM and NHL. ...The tbo-filgrastim and filgrastim arms were similar in all secondary endpoints. Tbo-filgrastim is not inferior in efficacy and has similar safety compared to reference filgrastim when used for stem cell mobilization in patients with MM and NHL. ...
We have conducted the first prospective randomized trial comparing the safety and efficacy of tbo-filgrastim in combination wi …
PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen(®)): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.
Yao HM, et al. BioDrugs 2019 - Clinical Trial. PMID 30900158 Free PMC article.
BACKGROUND: Three comparative clinical studies assessed the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and safety of PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar, versus US-licensed reference product (filgrastim; US-Neupogen(®)) in healthy volunteers (HVs). ...TRIAL REGISTRATION: ClinicalTrials.gov C1121002 (NCT02766647); C1121003 (NCT02766634); C1121012 (NCT02923791)....
BACKGROUND: Three comparative clinical studies assessed the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and safety o …
Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia.
Waller CF, et al. Ann Hematol 2019 - Clinical Trial. PMID 30824956 Free PMC article.
This was a phase 3, multicenter, randomized, double-blind, parallel-group equivalence trial of MYL-1401H vs European Union-sourced reference pegfilgrastim. ...
This was a phase 3, multicenter, randomized, double-blind, parallel-group equivalence trial of MYL-1401H vs European Union-sourced re …
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