Saracatinib for Idiopathic Pulmonary Fibrosis

(STOP-IPF Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called saracatinib for idiopathic pulmonary fibrosis (IPF), a lung condition that causes scarring and breathing difficulties. Researchers aim to determine if saracatinib is safe and effective for individuals with IPF. The study will compare saracatinib to a placebo (a pill with no active medicine) to better understand its impact. Individuals diagnosed with IPF who experience difficulty breathing or performing daily activities might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that saracatinib is likely to be safe for humans?

Research has shown that saracatinib, initially developed for certain cancers, is now being tested for safety in treating idiopathic pulmonary fibrosis (IPF), a serious lung disease. Studies have found that patients generally tolerate saracatinib well. Safety checks examine the frequency of health problems, known as adverse events, during treatment. Current evidence suggests that saracatinib might be as safe as, or even safer than, the two drugs already approved for IPF, nintedanib and pirfenidone. Additionally, the FDA has granted saracatinib Orphan Drug Designation, indicating its promise as a treatment for this rare condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pulmonary fibrosis?

Unlike the standard treatments for idiopathic pulmonary fibrosis, such as nintedanib and pirfenidone, saracatinib is unique because it targets the Src kinase pathway. This pathway plays a crucial role in the progression of fibrosis, and by inhibiting it, saracatinib has the potential to directly interfere with the disease process. Researchers are excited about this approach because it offers a new mechanism of action that could complement or enhance existing therapies, potentially leading to better outcomes for patients.

What evidence suggests that saracatinib might be an effective treatment for idiopathic pulmonary fibrosis?

Research has shown that saracatinib, which participants in this trial may receive, could be a promising treatment for idiopathic pulmonary fibrosis (IPF), a lung disease. In animal studies, saracatinib reversed lung damage seen in IPF, suggesting it might also reduce lung scarring in people. This drug blocks certain enzymes that cause tissue thickening and scarring. Additionally, early studies have shown that saracatinib is as effective, if not more so, than currently approved treatments for IPF. These findings offer hope that saracatinib might improve the quality of life for people with this challenging condition. ^{1 2 4 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9757097/

Saracatinib, a Selective Src Kinase Inhibitor, Blocks ... Saracatinib treatment results in the reversal of transcriptional changes observed in idiopathic pulmonary fibrosis (IPF) mouse models. (A) Comparison of number ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04598919

Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis The study includes the use of saracatinib, an investigational drug originally developed to treat certain types of cancers, in the treatment of IPF in a Phase 1b ...

3. clinicaltrial.be clinicaltrial.be/en/details/51459?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Saracatinib in the Treatment of Idiopathic Pulmonary Fibr... Efficacy of saracatinib in quality of life in IPF (SGRQ) as measured by total score on SGRQ questionnaire. Total score on the SGRQ questionnaire ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/iid3.1079

Idiopathic pulmonary fibrosis: Addressing the current and ... Preclinical trials investigating the potential of Saracatinib, a tyrosine kinase inhibitor, have shown to be more effective than current IPF ...

5. medicine.yale.edu medicine.yale.edu/news-article/following-computational-predictions-scientists-demonstrate-that-cancer-drug-counters-pulmonary-fibrosis/

Following Computational Predictions, Scientists Demonstrate ... The drug, saracatinib, works as well or better than current FDA-approved treatments for IPF at countering fibrosis in preclinical models.

6. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2019/us-fda-grants-saracatinib-orphan-drug-designation-for-idiopathic-pulmonary-fibrosis-18032019.html

US FDA grants saracatinib Orphan Drug Designation for ... The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for saracatinib, a potential new medicine for the treatment of idiopathic ...