Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis (STOP-IPF)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    100
  • sponsor
    National Jewish Health
Updated on 24 April 2022
tubal ligation
hysterectomy
scarring
follicle stimulating hormone
bronchodilator
idiopathic pulmonary fibrosis
diffusion capacity of the lung for carbon monoxide

Summary

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. 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/2a clinical trial.

The objectives of this study are to: i) evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and to explore the efficacy of saracatinib in IPF; ii) identify biomarkers of Src kinase activity and fibrogenesis linked to pulmonary fibrosis; and iii) explore the application of these biomarkers to assess the anti-fibrotic effect of saracatinib in IPF patients

Description

This is a double blind, randomized, placebo-controlled, single-dose, three-site trial. The trial is a biomarker-based, integrated Phase 1b/2a clinical trial involving 100 subjects. One group (n=50) will receive placebo, while the other group (n=50) will receive 125 mg of oral saracatinib once daily.

Randomization will be stratified by center. The randomization scheme will be in random blocks of 2 and 4 within each stratum to maintain balance. The study is designed to have interim analysis of the drop-out rates when approximately 30% of the randomized patients have achieved the 24-week assessment. Should the drop-out rate be higher than the 20% that is anticipated, a new sample size calculation will be performed to make sure that the power of the study is maintained at 80% .

Duration of follow-up will be 28 weeks including 24 weeks of treatment with saracatinib or placebo.

Details
Condition Idiopathic Pulmonary Fibrosis (IPF)
Treatment Placebo, Saracatinab
Clinical Study IdentifierNCT04598919
SponsorNational Jewish Health
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

IPF of any duration, confirmed or diagnosed by ILD center or expert according to Fleischner Guidelines (33)
Women or men >40 years of age at the time of screening
FVC%>45% of predicted value (GLI-2012)
Single breath DLCO% 30 - 79 inclusive of predicted (without bronchodilator and uncorrected for hemoglobin)
FEV1/FVC>70 (GLI-2012)
Provision of signed/dated written informed consent prior to any study-specific procedures
Females must be of nonchildbearing potential (defined as surgically sterilized [ie, bilateral tubal ligation, bilateral oophorectomy or complete hysterectomy] or postmenopausal [defined as 12 months with no menses without an alternative medical cause] with a follicle-stimulating hormone [FSH] > 25.8 IU/L) or use a highly effective method of contraception (defined as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; progestogen only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS) for the duration of the study (from the time they sign consent) 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 (defined as barrier methods in conjunction with spermicides) for the duration of the study (fr om 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

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 that, in the opinion of the investigator, would make it unsafe for the person to receive study drug
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
Liver function test results ≥3× upper limit of normal (ULN) liver isoform of aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGT), or alkaline phosphatase (ALP) or ≥2×ULN total bilirubin (excepting documentation of benign hereditary cause). An isolated total bilibrubin elevation (ie, no significant concomitant elevation in ALT or AST) at baseline of ≤ 2xULN is permitted. If there is concomitant elevation in ALT or AST to ≤3xULN, then the threshold for total bilirubrin is ≤1.5xULN
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)
Refer to 6.5 Concomitant Therapy for exclusions based on co-medications
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note