Clinical trials: Pegfilgrastim
Breast Cancer
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy
The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy
- Trial name
- NCT02805153
- Testing
- PEG-rhG-CSF, rhG-CSF
- Volunteers
- 215 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Breast Cancer
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia
The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy.
- Trial name
- NCT02805205
- Testing
- PEG-rhG-CSF
- Volunteers
- 484 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Lymphoma
PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy
The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lymphoma receiving chemotherapy.
- Trial name
- NCT02805218
- Testing
- PEG-rhG-CSF
- Volunteers
- 410 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Malignant Solid Tumors
PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy
The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.
- Trial name
- NCT02805166
- Testing
- PEG-rhG-CSF
- Volunteers
- 420 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Previously Treated Non Small Cell Lung Cancer
A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer
A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell Lung Cancer Patients
- Trial name
- NCT02087176
- Testing
- AZD1775, Antimitotic Agent, pegfiligrastim
- Where
- 12 sites in United States
- Volunteers
- 48 people
- Sponsor
- AstraZeneca
Ewing Family of Tumors, Rhabdomyosarcoma
PK/PD of XM22 in Children With Ewing Family of Tumors or Rhabdomyosarcoma
This is a Phase I, open label study aimed at assessing the pharmacokinetics, pharmacodynamics, the efficacy, safety, and tolerability of a single injection of XM22 in children with Ewing family of tumors or rhabdomyosarcoma…
- Trial name
- NCT01585649
- Testing
- Lipegfilgrastim
- Where
- 18 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 21 people
- Sponsor
- Merckle GmbH
Severe Chronic Neutropenia
Immunogenicity, Safety, and Efficacy of Zarzio®/Filgrastim HEXAL® in Patients With Severe Chronic Neutropenia
Purpose of the study is to investigate the safety, immunogenicity and the efficacy of Zarzio®/Filgrastim HEXAL® under chronic administration for 12 months in patients diagnosed with severe chronic neutropenia.
- Trial name
- NCT01859637
- Testing
- Filgrastim
- Where
- 2 sites in Germany, Sweden
- Volunteers
- 6 people
- Sponsor
- Sandoz
Immunity, Humoral
Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®
This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections…
- Trial name
- NCT02418104
- Testing
- CHS-1701, Pegfilgrastim (Neulasta)
- Where
- 4 sites in United States
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Coherus Oncology, Inc.
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.,
Bioequivalence
Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)
This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single…
- Trial name
- NCT02385851
- Testing
- CHS-1701, Pegfilgrastim
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Coherus Oncology, Inc.
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
Pharmacokinetics
A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
- Trial name
- NCT02205320
- Testing
- DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B
- Where
- United States
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects
Study Design Randomized, double-blind, placebo-controlled, escalating single-dose design. Six ascending dose cohorts In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control)…
- Trial name
- NCT01037543
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Chemotherapy Induced Neutropenia
GCPGC in Chemotherapy-induced Neutropenia
This study is adaptive design and it consists of stage I and stage II. Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia.
- Trial name
- NCT01328938
- Testing
- GCPGC 3.6mg, GCPGC 6mg, Neulasta (pegfilgrastim) 6mg
- Where
- 15 sites in South Korea
- Volunteers
- 177 people
- Sponsor
- Green Cross Corporation
Non-Hodgkin's Lymphoma
Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma
The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.
- Trial name
- NCT00115193
- Testing
- pegfilgrastim
- Volunteers
- 77 people
- Sponsor
- Amgen
Breast Cancer, Lung Cancer
A Study of Carboplatin/Paclitaxel With Pegfilgrastim Supported by Haematopoietic Progenitor Cell Re-Infusion in Whole Blood
The purpose of this study is to provide dose-finding information regarding the efficacy and kinetics of peripheral blood progenitor cell (PBPC) mobilisation by pegfilgrastim and to determine if carboplatin/paclitaxel can be…
- Conditions
- Breast Cancer, Lung Cancer, Ovarian Cancer
- Trial name
- NCT00117442
- Testing
- carboplatin, paclitaxel, pegfilgrastim
- Volunteers
- 61 people
- Sponsor
- Amgen
Neutropenia
Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy
Physicians are conducting a clinical trial for patients with advanced breast cancer. Breast cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced.
- Trial name
- NCT00035594
- Testing
- pegfilgrastim
- Volunteers
- 928 people
- Sponsor
- Amgen
Neutropenia
Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients
The purpose of this study is to examine the safety,tolerability,pharmacokinetics and pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.
- Trial name
- NCT01637493
- Testing
- Pegfilgrastim
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Neutropenia, Breast Cancer
A Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer
The purpose of this study is to assess pegfilgrastim starting with the first cycle versus secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays, dose reductions, and hospitalizations) in older…
- Conditions
- Neutropenia, Breast Cancer, Lung Cancer, Non-Hodgkin's Lymphoma
- Trial name
- NCT00277160
- Testing
- Neulasta (pegfilgrastim)
- Volunteers
- 852 people
- Sponsor
- Amgen
Sarcoma, Neutropenia
Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced.
- Trial name
- NCT00035620
- Testing
- pegfilgrastim, filgrastim
- Volunteers
- 44 people
- Sponsor
- Amgen