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 range40 Years
SexALL
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)
✓. 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
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
✓. 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