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Saracatinib for Idiopathic Pulmonary Fibrosis (STOP-IPF Trial)
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.
STOP-IPF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTOP-IPF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STOP-IPF Trial Design
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Who is running the clinical trial?
Media Library
- You have had a lung transplant in the past.Your lung function test shows that the ratio of FEV1 to FVC is greater than 70%.I am being treated for high blood pressure in my lungs.I am over 40 years old.You must provide written, dated consent before participating in any study activities.I need more than 4 liters of oxygen per minute to keep my oxygen levels above 90%.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.I am over 40 years old.I take more than 10 mg/day of prednisone or its equivalent.I am a man who is either surgically sterile or using contraception.I am either not able to have children or I use effective birth control.My lung biopsy shows a positive result for IPF.I am not able to have children, or I will use effective birth control during and 3 months after the study.My lung condition was confirmed by a specialist following specific guidelines.I am unable to understand and give consent for treatment.I am on the waiting list for a lung transplant.I do not have severe blood, kidney, liver, lung (not related to IPF), or metabolic conditions that would make it unsafe for me to take the study drug.Your lung function test shows that you can breathe out at least 45% of the expected amount.My lung condition was confirmed by a specialist following specific guidelines.I do not have an active infection.Your lung function is greater than 30% of what is expected for someone of your age and size.I cannot perform lung function tests.My kidney function is low, with a creatinine clearance under 30 mL/min.You need to have a certain level of lung function when you take a breathing test.You have smoked or used tobacco in the last 4 months.Your liver function test results show very high levels of certain enzymes or bilirubin.My doctor thinks I have more than 2.5 years to live, not counting my lung condition.I have not had cancer in the last 2 years, except for skin cancer.I cannot attend all the required study visits.I have not had major surgery in the last 2 months.I have hepatitis B or C.Your lung function, measured as FVC%, is higher than 45% of what is expected for someone of your age, gender, and height.Your FEV1/FVC ratio is greater than 70% according to the GLI-2012 guidelines.I was hospitalized or needed antibiotics for a sudden worsening of my lung condition within the last 90 days.You are allergic to any parts of saracatinib.I have taken pirfenidone or nintedanib in the last month.My CT scan results for lung scarring are unclear, but experts agree I likely have IPF.
- Group 1: Saracatinab
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- Icahn School of Medicine at Mount Sinai: < 48 hours
Average response time
- < 2 Days
Typically responds via
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