Saracatinib (AZD0530) in the Treatment of Patients with Idiopathic Pulmonary Fibrosis
- Study HIC#:2000028835
- Last Updated:04/21/2023
Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually fatal disorder. While two anti-fibrotic drugs have recently been approved for treating PF of unknown cause (idiopathic pulmonary fibrosis or IPF), neither drug is curative, and nearly 40% of patients stop taking the prescribed drug within a year because of side effects. We propose to study the use of saracatinib, an investigational drug originally developed to treat certain types of cancers, in the treatment of IPF in a Phase 1b/2a clinical trial
Study visits every 3-4 weeks
Treatment period 28weeks
Study treatment- Saracatinib 125mg/Placebo, pill 1:1 randomization ratio
- Age40 years and older
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Louise McLellan
- Phone Number: 1-203-785-4177
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
Eligibility Criteria
Inclusion Criteria:
- IPF of any duration
- Women or men >40 years of age at the time of screening
- Provision of signed/dated written informed consent prior to any study-specific procedures
- Females must be of nonchildbearing potential or postmenopausal or use a highly effective method of contraception for the duration of the study and for 3 months after the last dose of drug/matching placebo
- Male subjects must be surgically sterile or using an acceptable method of contraception for the duration of the study 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 and for 3 months after the last dose of drug/matching placebo.
Exclusion Criteria:
- Requirement for supplemental oxygen > 4 L/min at rest to maintain saturation > 90%
- Active infection at screening or randomization
- Known active or latent hepatitis B or C
- Life expectancy for disease other than IPF < 2.5 years (Investigator assessment)
- Listed for lung transplantation
- Taking pirfenidone or nintedanib in the last 4 weeks
- Pregnancy or lactation
- Known allergic reactions to components of saracatinib
- Treatment with another investigational drug or other intervention within 8 weeks
- Current smoker or tobacco use within 4 months
- Major surgery within the past 2 months
- Advanced hematologic, renal, hepatic, any lung disease determined by the investigator to be non-IPF related or metabolic disease a the discretion of the PI
- Previous lung transplantation
- Inability to attend scheduled study visits
- Inability to give informed consent
- Inability to perform pulmonary function testing
- History of malignancy in the past two years, other than squamous or basal cell skin cancer
- Previous acute exacerbation of IPF requiring hospitalization and/or antibiotics within 90 days before the first dose of the investigational product
- Abnormal Liver function test results
- Creatinine clearance <30 mL/min calculated by Cockcroft–Gault formula
- Known pulmonary hypertension (PH) requiring PH-specific treatment
- Chronic oral corticosteroids at doses greater than prednisone 10 mg/day (or equivalent)
