Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. IPF of any duration, confirmed or diagnosed by ILD center or expert according to Fleischner Guidelines (33) 2. Women or men >40 years of age at the time of screening. 3. FVC%>45% of predicted value (GLI-2012) 4. Single breath DLCO% 30
  • - 79 inclusive of predicted (without bronchodilator and uncorrected for hemoglobin) 5.
FEV1/FVC>70 (GLI-2012) 6. Provision of signed/dated written informed consent prior to any study-specific procedures. 7. 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. 8. 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:

1. Requirement for supplemental oxygen > 4 L/min at rest to maintain saturation > 90% 2. Active infection at screening or randomization. 3. Known active or latent hepatitis B or C. 4. Life expectancy for disease other than IPF < 2.5 years (Investigator assessment) 5. Listed for lung transplantation. 6. Taking pirfenidone or nintedanib in the last 4 weeks. 7. Pregnancy or lactation. 8. Known allergic reactions to components of saracatinib. 9. Treatment with another investigational drug or other intervention within 8 weeks. 10. Current smoker or tobacco use within 4 months. 11. Major surgery within the past 2 months. 12. 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. 13. Previous lung transplantation. 14. Inability to attend scheduled study visits. 15. Inability to give informed consent. 16. Inability to perform pulmonary function testing. 17. History of malignancy in the past two years, other than squamous or basal cell skin cancer. 18. Previous acute exacerbation of IPF requiring hospitalization and/or antibiotics within 90 days before the first dose of the investigational product. 19. 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. 20. Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula. 21. Known pulmonary hypertension (PH) requiring PH-specific treatment. 22. Chronic oral corticosteroids at doses greater than prednisone 10 mg/day (or equivalent) 23. Refer to 6.5 Concomitant Therapy for exclusions based on co-medications

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04598919
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Jewish Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gregory Downey, MDAnnetine C Gelijns, PhDNaftali Kaminski, MD
Principal Investigator Affiliation National Jewish HealthIcahn School of Medicine at Mount SinaiYale University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherIndustryNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis (IPF)
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Saracatinab

saracatinib 125 mg once daily by mouth for 24 weeks

Placebo Comparator: Placebo

matching placebo once daily by mouth for 24 weeks

Interventions

Drug: - Saracatinab

125 mg once daily by mouth for 24 weeks

Drug: - Placebo

once daily by mouth for 24 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Site Contact

Kaitlin Fier

fierk@njhealth.org

303-270-2852

Yale University School of Medicine, New Haven, Connecticut

Status

Recruiting

Address

Yale University School of Medicine

New Haven, Connecticut, 06510

Site Contact

Maksyn Minasyan

ildinfo@yale.edu

203-785-4177

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Shanti Mangar

shanti.mangar@mssm.edu

646-320-5303

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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