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Phase 1B/2

Saracatinib (AZD0530) in the Treatment of Patients with Idiopathic Pulmonary Fibrosis

  • Study HIC#:2000028835
  • Last Updated:07/15/2021

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
  • Start Date02/26/2021
  • End Date12/31/2023

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)

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