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Src kinase inhibitor

Saracatinib for Idiopathic Pulmonary Fibrosis (STOP-IPF Trial)

Phase 1 & 2
Recruiting
Led By Gregory Downey, MD
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

STOP-IPF Trial Summary

This trial tests the effectiveness of a new drug, saracatinib, in treating idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and usually fatal disorder.

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.Check my eligibility
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.See study design
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.

STOP-IPF Trial 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 over 40 years old.
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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.
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My CT scan results for lung scarring are unclear, but experts agree I likely have IPF.

STOP-IPF Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

STOP-IPF 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

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
36,321 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,245 Previous Clinical Trials
288,529,199 Total Patients Enrolled
2 Trials studying Idiopathic Pulmonary Fibrosis
97 Patients Enrolled for Idiopathic Pulmonary Fibrosis
National Jewish HealthLead Sponsor
140 Previous Clinical Trials
316,009 Total Patients Enrolled
4 Trials studying Idiopathic Pulmonary Fibrosis
9,101 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

Saracatinib (Src kinase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04598919 — Phase 1 & 2
Idiopathic Pulmonary Fibrosis Research Study Groups: Saracatinab, Placebo
Idiopathic Pulmonary Fibrosis Clinical Trial 2023: Saracatinib Highlights & Side Effects. Trial Name: NCT04598919 — Phase 1 & 2
Saracatinib (Src kinase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04598919 — Phase 1 & 2
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT04598919 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What chief aims have been set for this research endeavor?

"This 24-week trial is designed to assess the efficacy of saracatinib in idiopathic pulmonary fibrosis (IPF), as measured by Forced Vital Capacity changes. Secondary measures include an evaluation of Quality of Life, which will be gauged by a St. George's Respiratory Questionnaire; Diffusing Capacity of the Lung for Carbon Monoxide assessments; and timing to first acute exacerbations."

Answered by AI

What is the geographical scope of this trial?

"This clinical trial is being conducted at various sites including Baylor Scott & White Research Institute in Dallas, Yale University School of Medicine in New Haven, and National Jewish Health in Denver. Additionally, there are 4 additional medical centres involved with the study."

Answered by AI

Are there still opportunities for prospective individuals to join the clinical investigation?

"The data published on clinicaltrials.gov shows that this medical trial is actively accepting applications, with a post date of November 12th 2020 and most recent edit occurring October 18th 2022."

Answered by AI

What is the overall participant count for this research project?

"The sponsor, AstraZeneca, is looking to include 100 eligible participants in the trial which will be conducted across various clinics. Specifically, Baylor Scott & White Research Institute in Dallas and Yale University School of Medicine in New Haven are two locations offering participation opportunities."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Icahn School of Medicine at Mount Sinai
Baylor Scott & White Research Institute
Baylor University Medical Center (BUMC)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been on Ofev and has worked well ,but I think I am losing ground. i am taking nintedanib for more than 3 months and it does not seem to work. Need to try new medicine.
PatientReceived 1 prior treatment
As you know this disease cannot be cured, so I'd like to try this kind of treatment hoping that can help me making my life easier.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Icahn School of Medicine at Mount Sinai: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
~5 spots leftby Sep 2024