What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) are antifibrotic medications such as nintedanib and pirfenidone. Nintedanib is associated with side effects like diarrhea, liver enzyme elevation, and gastrointestinal issues. Pirfenidone commonly causes nausea, rash, and photosensitivity. Both drugs aim to slow disease progression and reduce acute exacerbations but are not curative. Saracatinib, a Src kinase inhibitor being studied for IPF, is still under investigation, and its side effects are not fully established yet.

What prior FDA approvals exist?

The FDA has approved two main anti-fibrotic drugs for the treatment of Idiopathic Pulmonary Fibrosis (IPF): pirfenidone and nintedanib. Pirfenidone is an oral antifibrotic agent that reduces fibroblast proliferation and collagen synthesis. Nintedanib is a tyrosine kinase inhibitor that targets multiple pathways involved in fibrosis, including platelet-derived growth factor, vascular endothelial growth factor, and fibroblast growth factor receptors. Both drugs have been shown to slow the progression of IPF. Saracatinib, currently under investigation, is a Src kinase inhibitor, which represents a different mechanism of action compared to the previously approved treatments.

What other types of research exist?

Promising novel alternatives to Saracatinib for IPF patients include Nintedanib, which is already licensed for SSc interstitial lung disease, and Pamrevlumab, an anti-connective tissue growth factor therapy that has shown positive results in a phase 2 trial. Both drugs are being actively studied and have shown potential in treating pulmonary fibrosis.

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Src kinase inhibitor

Saracatinib for Idiopathic Pulmonary Fibrosis (STOP-IPF Trial)

Phase 1 & 2

Waitlist Available

Led By Annetine Gelijns, PhD

Research Sponsored by National Jewish Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women or men >40 years of age at the time of screening

Male subjects must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of drug/matching placebo to prevent pregnancy in a partner. Male subjects must not donate or bank sperm for the duration of the study (from the time they sign consent) and for 3 months after the last dose of drug/matching placebo.

Must not have

Known pulmonary hypertension (PH) requiring PH-specific treatment

Requirement for supplemental oxygen > 4 L/min at rest to maintain saturation > 90%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of saracatinib in IPF are being studied, potential risks may include typical reactions seen in other treatments like digestive issues, liver enzyme changes, fatigue, skin reactions or increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 40 years old.

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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.

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I am a man who is either surgically sterile or using contraception.

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I am either not able to have children or I use effective birth control.

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My lung biopsy shows a positive result for IPF.

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My lung condition was confirmed by a specialist following specific guidelines.

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My lung condition was confirmed by a specialist following specific guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I need more than 4 liters of oxygen per minute to keep my oxygen levels above 90%.

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I take more than 10 mg/day of prednisone or its equivalent.

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I am unable to understand and give consent for treatment.

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I am on the waiting list for a lung transplant.

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I do not have an active infection.

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I cannot perform lung function tests.

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My kidney function is low, with a creatinine clearance under 30 mL/min.

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I have not had cancer in the last 2 years, except for skin cancer.

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I cannot attend all the required study visits.

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I have not had major surgery in the last 2 months.

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I have hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of saracatinib in IPF as measured by change in FVC

Pharmacodynamics of saracatinib in IPF as measured by change in serum β-CTX

Pharmacokinetics of saracatinib in IPF as measured by serum levels

+2 more

Secondary study objectives

Efficacy of saracatinib in IPF (DLCO) as measured by change in DLCO

Efficacy of saracatinib in IPF (HRCT)

Efficacy of saracatinib in IPF (exacerbations) as measured in time to first acute exacerbation

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SaracatinabActive Control1 Intervention

saracatinib 125 mg once daily by mouth for 24 weeks

Group II: PlaceboPlacebo Group1 Intervention

matching placebo once daily by mouth for 24 weeks

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) are nintedanib and pirfenidone. Nintedanib is a tyrosine kinase inhibitor that targets multiple growth factor receptors involved in the fibrotic process, thereby slowing disease progression by inhibiting pathways that lead to fibrosis. Pirfenidone works by reducing fibroblast proliferation, cytokine production, and collagen synthesis, which collectively help to slow the progression of lung scarring. Saracatinib, an investigational Src kinase inhibitor, aims to block specific signaling pathways involved in fibrosis. These treatments are crucial for IPF patients as they help to slow the decline in lung function, potentially improving quality of life and extending survival.