Clinical trials: Pegfilgrastim
Healthy Volunteer
Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): TPI-120 Injection 6 mg/0.6 mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with…
- Trial name
- NCT07416955
- Testing
- TPI-120 Pre-Filled Syringe 6 mg/0.6 mL
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Breast Cancer
Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer
The purpose of this study is to compare the immunogenicity of Peg-filgrastim versus Neulasta® as an adjunct to chemotherapy in patients with breast cancer
- Trial name
- NCT03511378
- Testing
- Lupin's Pegfilgrastim, Neulasta®
- Where
- 17 sites in India
- Volunteers
- 138 people
- Sponsor
- Lupin Ltd.
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, Healthy
Pharmacokinetics and Pharmacodynamics Comparison Study Between Two Pegfilgrastim Formulations
This study will evaluate the pharmacokinetics (relative bioavailability) and pharmacodynamics, after single subcutaneous application, in healthy volunteers of both sexes, between pegfilgrastim formulation, produced by Eurofarma…
- Trial name
- NCT02589301
- Testing
- Pegfilgrastim
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eurofarma Laboratorios S.A.
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, 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
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor…
- Trial name
- SELECT-1 (NCT01933932)
- Testing
- Selumetinib, Docetaxel, Pegylated G-CSF
- Where
- 197 sites in United States, Argentina and 24 more
- Volunteers
- 510 people
- Sponsor
- AstraZeneca
Chemotherapy-induced Neutropenia
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3
To assess Duration of Severe Neutropenia (DSN) in treatment Cycle 1 in patients with advanced or metastatic breast cancer, who have failed >/= 1 but < 5 prior lines of chemotherapy; locally advanced or metastatic non small cell…
- Trial name
- Protective-1 (NCT03102606)
- Testing
- Plinabulin, Pegfilgrastim
- Where
- 18 sites in United States, China and 2 more
- Volunteers
- 105 people
- Sponsor
- BeyondSpring Pharmaceuticals 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.
Ovarian Cancer, Epithelial Ovarian Cancer
REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1
A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.
- Conditions
- Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- NCT05870748
- Testing
- Luveltamab tazevibulin, Pegfilgrastim, Gemcitabine
- Where
- 63 sites in United States, Australia and 5 more
- Volunteers
- 600 people
- Sponsor
- Sutro Biopharma, Inc.
Neutropenia
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.
- Trial name
- NCT00364468
- Testing
- pegfilgrastim
- Where
- 6 sites in Japan
- Volunteers
- 107 people
- Sponsor
- Kyowa Kirin 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, Fever
Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC)
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.
- Conditions
- Breast Cancer, Fever, Neutropenia
- Trial name
- NCT00115414
- Testing
- pegfilgrastim, docetaxel, doxorubicin
- Sponsor
- Amgen
Healthy Volunteers
Comparative Immunogenicity Study Comparing TPI-120 to Neulasta® in Healthy Adult Subjects
This study will compare treatment emergent incidence rate of ADA between TPI-120 and US licensed Neulasta in normal healthy adult subjects
- Trial name
- TPI-120 (NCT03202927)
- Testing
- PEGFILGRASTIM
- Where
- 2 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Adello Biologics, LLC
Multiple Myeloma and Malignant Lymphoma
A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma
To determine if KRN125 is non-inferior to filgrastim for the mobilization of hematopoietic stem cells into the peripheral blood in patients with multiple myeloma.
- Trial name
- NCT05007652
- Testing
- KRN125(pegfilgrastim), PLR001(plerixafor), KRN8601(filgrastim), PLR001(plerixafor)
- Where
- 21 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Pharmacokinetics, Pharmacodynamics
PK, PD, Safety and Tolerability of Lipegfilgrastim in Healthy Japanese and Caucasian Participants
Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian participants for the sake of matching.
- Trial name
- NCT02306915
- Testing
- lipegfilgrastim
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merckle GmbH
Neutropenia, Chemotherapy-Induced Febrile, Breast Neoplasm Female
Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy
To evaluate the efficacy, safety, and immunogenicity of PEG-G-CSF Injection (Kexing Biopharmaceutical Co., Ltd.) for the prevention of neutropenia after chemotherapy, using the PEG-G-CSF Injection ( Neulasta®, Amgen Europe B.V.)…
- Trial name
- NCT06711523
- Testing
- PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.), PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)
- Where
- China
- Volunteers
- 250 people
- Sponsor
- Kexing Biopharm Co., Ltd.
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.
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
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