Clinical trials: Pegfilgrastim
Advanced Cancer
A Dose-Escalation Study for Patients With Advanced Cancer
This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).
- Trial name
- NCT01214642
- Testing
- pegfilgrastim, LY2523355
- Where
- 2 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eli Lilly and Company
Neutropenia
Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.
- Trial name
- PEG-rhG-CSF (NCT01918241)
- Testing
- pegfilgrastim,30mcg/kg, pegfilgrastim, 60mcg/kg, pegfilgrastim, 100mcg/kg
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Chemotherapy Associated Neutropenia, Breast Cancer
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
- Trial name
- PIONEER (NCT01519700)
- Testing
- EP2006, Filgrastim
- Where
- 26 sites in Czechia, Hungary and 4 more
- Volunteers
- 218 people
- Sponsor
- Sandoz
Breast Cancer
A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer
The purpose of this study is to assess the relative dose intensity (RDI) of intravenous (IV) CMF on a Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with stage I-III breast cancer.
- Trial name
- NCT00124111
- Testing
- pegfilgrastim, cyclophosphamide, methotrexate
- Sponsor
- Amgen
Healthy Volunteers
Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta
This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.
- Trial name
- NCT02479646
- Testing
- MYL-1401H, EU-Neulasta, US-Neulasta
- Where
- Netherlands
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Ewing's Sarcoma
A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma
A two-part trial in patients with metastic Ewing's sarcoma. Participants in Part 1 will be randomized to receive either Vigil immunotherapy or gemcitabine and docetaxel with the objective of comparing the overall survival between…
- Trial name
- NCT02511132
- Testing
- Vigil, Temozolomide, Irinotecan
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Gradalis, Inc.
Peripheral Blood Stem Cell Transplantation
KRN125 for Mobilization of Hematopoietic Stem Cells
Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.
- Trial name
- NCT03993639
- Testing
- Pegfilgrastim
- Where
- Japan
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
Triple-negative Breast Cancer
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and…
- Trial name
- IMpassion031 (NCT03197935)
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Nab-paclitaxel, Doxorubicin
- Where
- 68 sites in United States, Australia and 11 more
- Volunteers
- 333 people
- Sponsor
- Hoffmann-La Roche
Neutropenia, Breast Cancer
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia…
- Trial name
- NCT02953340
- Testing
- SPI-2012, Pegfilgrastim, Docetaxel
- Where
- 74 sites in United States, Canada and 4 more
- Volunteers
- 237 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Lymphoma, Hodgkin's Lymphoma
Pegfilgrastim PBPC Mobilization Study
This is a randomized, double-blind, multi-center study to assess the safety and effectiveness of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily subcutaneous injections of Filgrastim to mobilize…
- Conditions
- Lymphoma, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Hematology
- Trial name
- NCT00066092
- Testing
- pegfilgrastim 12 mg, filgrastim, pegfilgrastim 6 mg
- Volunteers
- 41 people
- Sponsor
- Amgen
Healthy
A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Qilu Pharmaceutical Co., Ltd.
- Trial name
- NCT04651036
- Testing
- QL0605, US Neulasta
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia
A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia
The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.
- Trial name
- AVOID (NCT02044276)
- Testing
- lipegfilgrastim, pegfilgrastim
- Where
- 60 sites in Germany, Italy and 1 more
- Volunteers
- 101 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Breast Cancer Female
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 \& day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical…
- Trial name
- NCT03381417
- Testing
- pegcyte, Neulastim
- Where
- Vietnam
- Volunteers
- 128 people
- Sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
Chemotherapy-induced Neutropenia
Plinabulin iv Solution in Prevention of TAC Induced Neutropenia
The primary purpose of this study is to compare the duration of severe neutropenia (DSN) in patients treated with: Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus Docetaxel, doxorubicin, and…
- Trial name
- NCT04227990
- Testing
- Plinabulin, Pegfilgrastim, Docetaxel, doxorubicin, and cyclophosphamide (TAC)
- Where
- 11 sites in China, Ukraine
- Volunteers
- 115 people
- Sponsor
- BeyondSpring Pharmaceuticals Inc.
Breast Cancer
Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients
Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be enrolled in this study. Eligible patients receive single SC injection of pegcyte or neulastim 24 hours after administration of…
- Trial name
- NCT03376503
- Testing
- Pegfilgrastim
- Where
- Vietnam
- Volunteers
- 24 people
- Sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
Diffuse Large B Cell Lymphoma Relapsed, Diffuse Large B Cell Lymphoma Refractory
Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma
This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with relapsed/refractory Diffuse Large B-cell Lymphoma…
- Trial name
- NCT02142049
- Testing
- Ibrutinib, DA-EPOCH-R, Lenalidomide
- Where
- 10 sites in United States
- Volunteers
- 35 people
- Sponsor
- Pharmacyclics LLC.
Chemotherapy-induced Neutropenia
Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing…
- Trial name
- NCT03559387
- Testing
- ANF-RHO™, Neulasta®
- Where
- 8 sites in France, Netherlands
- Volunteers
- 9 people
- Sponsor
- Prolong Pharmaceuticals
Neutropenia
Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product)…
- Trial name
- NCT04873765
- Testing
- Pegfilgastrim Megalabs, Pegfilgastim Amgen
- Where
- Uruguay
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Megalabs
Healthy Volunteers
Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects
Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in…
- Trial name
- NCT02912377
- Testing
- Neulasta, B12019
- Where
- Germany
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Cinfa Biotech
Lung Cancer, Non-Small Cell Lung Cancer
Pegfilgrastim Given Same Day As or Day After Carboplatin and Docetaxel in Advanced Metastatic Non-Small Cell Lung Cancer (NSCLC)
The purpose of this research study is to evaluate the safety and effectiveness of Neulasta® (pegfilgrastim) in reducing infection when given on the same day versus one day after the completion of chemotherapy (docetaxel and…
- Trial name
- NCT00094822
- Testing
- PI Discretion
- Volunteers
- 90 people
- Sponsor
- Amgen