Clinical trials: Pegfilgrastim
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.
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
Bladder Cancer
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body.
- Trial name
- TroFuse-055 (NCT07829783)
- Testing
- Sac-TMT, Pembrolizumab and Berahyaluronidase alfa, Cisplatin
- Volunteers
- 400 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
Immunogenicity, Healthy Volunteers
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human 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; Intas Pharmaceuticals Ltd.
- Trial name
- NCT04015232
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Breast Cancer
Trial to Compare the Efficacy and Safety of Pegfilgrastim Biosimilar in Subjects With High Risk Stage Breast Cancer Receiving Chemotherapy
This is a Phase III, randomised, assessor-blind, parallel group, multicentre trial. At least 180 adult subjects with high-risk Stage II or Stage III / IV breast cancer will be randomised (1:1) to receive either Eurofarma's…
- Trial name
- NCT02768714
- Testing
- Eurofarma's pegfilgrastim, Neulastim
- Sponsor
- Eurofarma Laboratorios S.A.
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
Bone Pain in Stage I - III Breast Cancer
NOLAN: Naproxen or Loratadine and Neulasta
The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic…
- Trial name
- NOLAN (NCT01712009)
- Testing
- Naproxen, Loratadine, Pegfilgrastim
- Where
- 83 sites in United States
- Volunteers
- 600 people
- Sponsor
- Amgen
Chemotherapy-induced Neutropenia
Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN
The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran. The primary objective of this study was safety assessment, including the rate of AEs.
- Trial name
- NCT04460079
- Testing
- Peg-filgrastim
- Volunteers
- 654 people
- Sponsor
- Cinnagen
Bladder Cancer
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy.
- Trial name
- TroFuse-031 (NCT07419295)
- Testing
- Sacituzumab tirumotecan, Vinflunine, Docetaxel
- Where
- 111 sites in United States, Argentina and 15 more
- Volunteers
- 590 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
Treatment for Elderly Patients With High Risk Breast Cancer
This open-label, multicenter study explored primary and secondary prophylaxis treatment with a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with high-risk breast cancer receiving…
- Trial name
- NCT00117910
- Testing
- pegfilgrastim
- Sponsor
- Amgen
Neutropenia
A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-approved Neulasta.
- Trial name
- NCT02629289
- Testing
- HSP-130, US-approved Neulasta, EU-approved Neulasta
- Where
- Australia
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Non-Hodgkin's Lymphoma
Treatment for Subjects With Non-Hodgkin's Lymphoma
This multicenter, open-label, randomized, parallel study was designed to evaluate whether a single fixed-dose subcutaneous (SC) administration of pegfilgrastim or daily administration of Filgrastim for absolute neutrophil count…
- Trial name
- NCT00117897
- Testing
- pegfilgrastim, Filgrastim
- Sponsor
- Amgen
Epithelial Ovarian Cancer, Primary Peritoneal
CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
- Conditions
- Epithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer, Endometrioid Ovarian Cancer
- Trial name
- NCT06690775
- Testing
- TORL-1-23, Pegfilgrastim (drug)
- Where
- 66 sites in United States, Australia and 10 more
- Volunteers
- 230 people
- Sponsor
- TORL Biotherapeutics, LLC
Neutropenic Complications, Breast Neoplasms
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
- Conditions
- Neutropenic Complications, Breast Neoplasms, Chemotherapy-induced Neutropenia, Chemotherapeutic Toxicity
- Trial name
- PROTECT-1 (NCT01735175)
- Testing
- LA-EP2006, Neulasta®
- Where
- 41 sites in Brazil, India and 4 more
- Volunteers
- 316 people
- Sponsor
- Sandoz
Neutropenia
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.
- Trial name
- NCT01724866
- Testing
- SPI-2012, Pegfilgrastim, Docetaxel
- Where
- 27 sites in United States, Australia and 4 more
- Volunteers
- 148 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Myelodysplastic Syndromes
Clofarabine for Myelodysplastic Syndrome (MDS) Patients Who Failed Vidaza Treatment (tx)
The investigators hypothesize that, in addition to its apoptotic effect, clofarabine induces DNA hypomethylation. If the investigators' hypothesis is correct, findings from the present proposal will not only contribute to…
- Trial name
- NCT00700011
- Testing
- Clofarabine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Texas Oncology Cancer Center
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
Advanced Cancer, Metastatic Cancer
A Study for Participants 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
- NCT01214629
- Testing
- LY2523355, pegfilgrastim
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Eli Lilly and Company