Saracatinib for Idiopathic Pulmonary Fibrosis

(STOP-IPF Trial)

Recruiting at 4 trial locations

Overseen By Sarah Burris

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Jewish Health

Must not be taking: Pirfenidone, Nintedanib, Corticosteroids, others

Disqualifiers: Hepatitis, Lung transplant, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

49 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug for treating idiopathic pulmonary fibrosis (IPF). It aims to block a protein that causes lung scarring, seeking a safer and more effective treatment for this severe lung disease. Originally developed for cancer, this drug is now being explored for its potential to treat IPF by blocking proteins involved in lung scarring.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken pirfenidone or nintedanib in the last 4 weeks. It's best to discuss your current medications with the trial team.

How is the drug saracatinib different from other treatments for idiopathic pulmonary fibrosis?

Saracatinib is unique because it is a selective Src kinase inhibitor, originally developed for cancer, that targets specific fibrogenic pathways in idiopathic pulmonary fibrosis (IPF). Unlike standard treatments, it has shown potential to be more effective in reducing fibrosis and inflammation in preclinical models and human lung cells. ^{1 2 3 4 5}

Research Team

Susan Mathai, MD

Principal Investigator

Baylor University Medical Center (BUMC)

Danielle Antin-Ozerkis, MD

Principal Investigator

Yale University

Annetine Gelijns, PhD

Principal Investigator

Data and Clinical Coordinating Center- InCHOIR

Gregory Downey, MD

Principal Investigator

National Jewish Health

Maria Padilla, M.D.

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for men and women over 40 with idiopathic pulmonary fibrosis (IPF), confirmed by specific guidelines. Participants must have a certain lung function level, not be current smokers, and able to perform pulmonary tests. Men should use contraception or be sterile; women must be nonchildbearing or also use contraception.

Inclusion Criteria

Your lung function test shows that the ratio of FEV1 to FVC is greater than 70%.

I am over 40 years old.

I am a man using reliable birth control or am surgically sterile, and I won't donate sperm during the study and for 3 months after.

Exclusion Criteria

Pregnancy or lactation

You have had a lung transplant in the past.

I am being treated for high blood pressure in my lungs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 125 mg of oral saracatinib or placebo once daily

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Saracatinib

Trial Overview The study is testing saracatinib, a drug initially developed for cancer treatment, against a placebo to see if it's safe and effective for IPF patients. It will also look at how the body processes the drug and search for biomarkers related to lung scarring.

Participant Groups

Group I: Saracatinab Active Control 1 Intervention

saracatinib 125 mg once daily by mouth for 24 weeks

Group II: Placebo Placebo Group 1 Intervention

matching placebo once daily by mouth for 24 weeks

Who Is Running the Clinical Trial?

National Jewish Health

Lead Sponsor

Trials

145

Recruited

318,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

National Center for Advancing Translational Science (NCATS)

Collaborator

Trials

100

Recruited

32,100+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

International Center for Health Outcomes and Innovation Research

Collaborator

Trials

6

Recruited

970+

Baylor University

Collaborator

Trials

65

Recruited

67,600+

Findings from Research

A systematic review of six studies showed that pirfenidone, nintedanib, and pamrevlumab are all effective in slowing the decline of forced vital capacity (FVC) in patients with idiopathic pulmonary fibrosis (IPF), with pamrevlumab showing the highest effect size.

Only pirfenidone demonstrated a significant impact on all-cause mortality, suggesting it may offer additional benefits beyond just slowing FVC decline, while pamrevlumab is emerging as a promising candidate for future treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Pirfenidone, Nintedanib, and Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis. Di Martino, E., Provenzani, A., Vitulo, P., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Differences in Treatment Response in Bronchial Epithelial Cells from Idiopathic Pulmonary Fibrosis (IPF) Patients: A First Step towards Personalized Medicine? [2023]

2. England pubmed.ncbi.nlm.nih.gov

Airway basal cells show a dedifferentiated KRT17highPhenotype and promote fibrosis in idiopathic pulmonary fibrosis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Saracatinib, a Selective Src Kinase Inhibitor, Blocks Fibrotic Responses in Preclinical Models of Pulmonary Fibrosis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Experience with Nintedanib in Patients with Idiopathic Pulmonary Fibrosis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Pirfenidone, Nintedanib, and Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis. [2021]