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FG-3019

DRUG10 trials

Sponsors

Kyntra Bio, FibroGen, Jonsson Comprehensive Cancer Center

Conditions

Diabetes MellitusDiabetic Kidney DiseaseDiabetic NephropathyFocal Segmental GlomerulosclerosisIdiopathic Pulmonary FibrosisLiver Fibrosis Due to Chronic Hepatitis B InfectionLocally Advanced or Metastatic Pancreatic CancerPancreatic Cancer

Phase 1

Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis
CompletedNCT00074698
Kyntra BioIdiopathic Pulmonary Fibrosis
Start: 2003-12-08End: 2004-05-31Updated: 2023-07-12
Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus
CompletedNCT00102297
FibroGenDiabetes Mellitus
Start: 2005-01-31End: 2007-06-30Target: 20Updated: 2007-12-12
Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy
CompletedNCT00754143
Kyntra BioDiabetes Mellitus, Diabetic Nephropathy
Start: 2008-03-31End: 2009-12-31Updated: 2019-08-02
Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)
TerminatedNCT00782561
Kyntra BioFocal Segmental Glomerulosclerosis
Start: 2008-04-30End: 2009-06-18Updated: 2019-07-31
A Phase 1 Study of Safety and Bioactivity With FG-3019 in Combination With Gemcitabine and Erlotinib for Subjects With Locally Advanced or Metastatic Pancreatic Cancer
CompletedNCT01181245
Kyntra BioLocally Advanced or Metastatic Pancreatic Cancer
Start: 2008-12-31End: 2014-06-30Target: 50Updated: 2014-08-06
A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
CompletedNCT02210559
Kyntra BioPancreatic Cancer (Unresectable)
Start: 2014-07-31End: 2021-12-15Updated: 2023-03-02

Phase 2

Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy
TerminatedNCT00913393
FibroGenDiabetic Kidney Disease, Diabetic Nephropathy, Type 2 Diabetes Mellitus
Start: 2009-02-28End: 2010-06-30Updated: 2019-02-22
A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection
TerminatedNCT01217632
Kyntra BioLiver Fibrosis Due to Chronic Hepatitis B Infection
Start: 2010-08-31End: 2015-06-30Updated: 2016-08-16
Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis
CompletedNCT01262001
Kyntra BioIdiopathic Pulmonary Fibrosis
Start: 2011-03-31End: 2017-06-21Updated: 2019-10-09

Unknown Phase

Compassionate Single Subject Use of FG-3019 (FibroGen) in Locally Advanced, Unresectable Pancreatic Cancer
WithdrawnNCT02851381
Jonsson Comprehensive Cancer CenterPancreatic Cancer
Start: 2016-08-31End: 2017-08-31Updated: 2016-10-07

Related Papers

Minimum clinically important difference in Quantitative Lung Fibrosis score associated with all-cause mortality in idiopathic pulmonary fibrosis: subanalysis from two phase II trials of pamrevlumab
BMJ Open2025-05-01
LAPIS: Randomized phase 3 trial of chemotherapy (CTX) with and without pamrevlumab (PAM) for locally advanced pancreatic cancer (LAPC).
Journal of Clinical Oncology2025-01-276 citations
Abstract 983: Design and methodology of LAPIS, an ongoing, phase III trial of neoadjuvant pamrevlumab (pam) with chemotherapy (CT) in patients (pts) with unresectable, locally advanced pancreatic cancer (LAPC)
Cancer Research2023-04-041 citations
Prognostic utility of inflammation biomarkers in a PDAC trial involving the human anti-CTGF antibody pamrevlumab.
Journal of Clinical Oncology2020-02-012 citations
Effect of anti-CTGF human recombinant monoclonal antibody pamrevlumab on resectability and resection rate when combined with gemcitabine/nab-paclitaxel in phase 1/2 clinical study for the treatment of locally advanced pancreatic cancer patients.
Journal of Clinical Oncology2018-05-2019 citations
Randomized, open-label trial of gemcitabine/nab-paclitaxel (G/NP) ± pamrevlumab (P) as neoadjuvant chemotherapy in locally advanced, unresectable pancreatic cancer (LAPC).
Journal of Clinical Oncology2017-02-0111 citations
Randomized, open-label trial of gemcitabine/nab-paclitaxel (G/NP) ±FG-3019 as neoadjuvant chemotherapy in locally advanced, unresectable pancreatic cancer (LAPC).
Journal of Clinical Oncology2016-02-013 citations
A randomized, open-label, phase I/II trial of gemcitabine plus nab-paclitaxel with or without FG-3019 as neoadjuvant chemotherapy in locally advanced, unresectable pancreatic cancer.
Journal of Clinical Oncology2015-01-204 citations
FG-3019, a human monoclonal antibody to connective tissue growth factor (CTGF), with gemcitabine/erlotinib (G/E) in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC).
Journal of Clinical Oncology2014-05-2012 citations