Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually
fatal disorder. While two anti-fibrotic drugs have recently been approved for treating PF of
unknown cause (idiopathic pulmonary fibrosis or IPF), neither drug is curative, and nearly
40% of patients stop taking the prescribed drug within a year because of side effects. The
study includes the use of saracatinib, an investigational drug originally developed to treat
certain types of cancers, in the treatment of IPF in a Phase 1b/2a clinical trial.
The objectives of this study are to: i) evaluate the safety, tolerability, pharmacokinetics
and pharmacodynamics, and to explore the efficacy of saracatinib in IPF; ii) identify
biomarkers of Src kinase activity and fibrogenesis linked to pulmonary fibrosis; and iii)
explore the application of these biomarkers to assess the anti-fibrotic effect of saracatinib
in IPF patients
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Jewish Health
Collaborators:
AstraZeneca Icahn School of Medicine at Mount Sinai National Center for Advancing Translational Science (NCATS) Yale University