Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis (NCT04598919) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis
United States49 participantsStarted 2020-11-12
Plain-language summary
Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually fatal disorder. While two anti-fibrotic drugs have 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
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. IPF of any duration, confirmed or diagnosed by ILD center or expert according to Fleischner Guidelines (33). Subjects with a probable or indeterminant CT scan who otherwise meet the Fleischner criteria for IPF are eligible to be included in the study after a multidisciplinary evaluation. A positive Envisia genomic classifier score (34) on a lung biopsy specimen will be considered as strong evidence for a diagnosis of IPF. Subjects with a positive invisia genomic classifier score in conjunction with a probable or indeterminant CT scan are eligible to be included in the study after a multidisciplinary evaluation.
. Women or men \>40 years of age at the time of screening
. FVC%\>45% of predicted value (GLI-2012)
. Single breath DLCO% ≥ 30 - inclusive of predicted (without bronchodilator and uncorrected for hemoglobin GLI-2017)
. FEV1/FVC\>70 (GLI-2012)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of saracatinib in IPF as measured by frequency of adverse events
Timeframe: 24 weeks
2
Tolerability of saracatinib in IPF as measured by Severity of adverse events
Timeframe: 24 weeks
3
Pharmacokinetics of saracatinib in IPF as measured by serum levels
Timeframe: 24 weeks
4
Pharmacodynamics of saracatinib in IPF as measured by change in serum β-CTX
Timeframe: 24 weeks
5
Efficacy of saracatinib in IPF as measured by change in FVC
. Provision of signed/dated written informed consent prior to any study-specific procedures
. Females must be of nonchildbearing potential (defined as surgically sterilized \[i.e., bilateral tubal ligation, bilateral oophorectomy or complete hysterectomy\] 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 (from 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