Saracatinib for Idiopathic Pulmonary Fibrosis

(STOP-IPF Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Susan Mathai, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Jewish Health

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.

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.

Treatment Details

Interventions

• Saracatinib (Src kinase inhibitor)

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+

Michael Salem

National Jewish Health

Chief Executive Officer since 2006

MD from George Washington University School of Medicine and Health Sciences

Lisa Maier

National Jewish Health

Chief Medical Officer since 2023

MD

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Dominique C. Pichard

National Center for Advancing Translational Sciences (NCATS)

Chief Medical Officer since 2023

MD

Joni L. Rutter

National Center for Advancing Translational Sciences (NCATS)

Chief Executive Officer since 2022

PhD in Pharmacology

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

National Center for Advancing Translational Science (NCATS)

Collaborator

Trials

100

Recruited

32,100+

Joni L. Rutter

National Center for Advancing Translational Science (NCATS)

Chief Executive Officer since 2022

PhD in Pharmacology

Dominique C. Pichard

National Center for Advancing Translational Science (NCATS)

Chief Medical Officer since 2023

MD

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+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

International Center for Health Outcomes and Innovation Research

Collaborator

Trials

6

Recruited

970+

Baylor University

Collaborator

Trials

65

Recruited

67,600+

Dr. Paul Klotman

Baylor University

Chief Executive Officer since 2010

MD, FACP

Dr. James G. Marsh

Baylor University

Chief Medical Officer

MD