Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis (STOP-IPF)
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|ClinicalTrials.gov Identifier: NCT04598919|
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : February 9, 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. 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
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis (IPF)||Drug: Saracatinab Drug: Placebo||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This will be a randomized (1:1 ratio), double blind, parallel design, placebo controlled trial.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||This is a randomized clinical trial, in which the patients and investigators are masked to treatment assignment.|
|Official Title:||Use of the Src Family Kinase Inhibitor Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis|
|Actual Study Start Date :||November 12, 2020|
|Estimated Primary Completion Date :||September 28, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Active Comparator: Saracatinab
saracatinib 125 mg once daily by mouth for 24 weeks
125 mg once daily by mouth for 24 weeks
Placebo Comparator: Placebo
matching placebo once daily by mouth for 24 weeks
once daily by mouth for 24 weeks
- Safety of saracatinib in IPF as measured by frequency of adverse events [ Time Frame: 24 weeks ]Safety data will be listed and summarized with patient counts and percentages in each treatment arm
- Tolerability of saracatinib in IPF as measured by Severity of adverse events [ Time Frame: 24 weeks ]A listing of all adverse eventsw by patient will be presented. This listing will include patient number, adverse event (actual term and preferred term), event stand and end dates, CTCAE grade, relationship to the study drug/procedure, seriousness and outcome. A listing of SAEs will be produced using the similar format. This is not a scale. It is a data capture tool.
- Pharmacokinetics of saracatinib in IPF as measured by serum levels [ Time Frame: 24 weeks ]Serum levels of saracatinib
- Pharmacodynamics of saracatinib in IPF as measured by change in serum β-CTX [ Time Frame: 24 weeks ]Change in serum β-CTX as a Src kinase dependent biomarker
- Efficacy of saracatinib in IPF as measured by change in FVC [ Time Frame: 24 weeks ]Change in FVC from baseline
- Efficacy of saracatinib in IPF (HRCT) [ Time Frame: 24 weeks ]Change in HRCT quantitative analysis of the extent of pulmonary fibrosis. The analysis pf HRCT data will involve data-driven texture analysis (DTA), a machine learning method capable of automatic detection and quantification of lung fibrosis on HRCT
- Efficacy of saracatinib in IPF (DLCO) as measured by change in DLCO [ Time Frame: 24 weeks ]Change in diffusing capacity of the lung for carbon monoxide (DLCO)
- Efficacy of saracatinib in IPF (exacerbations) as measured in time to first acute exacerbation [ Time Frame: 24 weeks ]Time to the first acute exacerbation
- Efficacy of saracatinib in quality of life in IPF (SGRQ) as measured by total score on SGRQ questionnaire [ Time Frame: 24 weeks ]Total score on the SGRQ questionnaire. St. George's Respiratory Questionnaire (SGRQ) is a 50-item, self-administered, respiratory-specific questionnaire with items covering three domains: symptoms, activities, impacts. Each domain and a total score range from 0-100, with higher scores connoting greater impairment.
- Efficacy of saracatinib in quality of life in IPF (L-IPF) as measured by total score on L-IPF questionnaire [ Time Frame: 24 weeks ]Total score on the L-IPF questionnaire. Living with IPF (L-IPF) is an IPF-specific questionnaire whose 43 items cover two modules: symptoms and impacts. A model-based scoring algorithm has been developed via psychometric methods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598919
|Contact: Emily Kinzel, MSfirstname.lastname@example.org|
|Contact: Ellen G Moquete, MSH||(212) email@example.com|
|United States, Colorado|
|National Jewish Health||Recruiting|
|Denver, Colorado, United States, 80206|
|Contact: Kaitlin Fier 303-270-2852 firstname.lastname@example.org|
|Contact: Kris Eliopoulos, RN 303-398-2622 email@example.com|
|Principal Investigator: Gregory Downey, MD|
|United States, Connecticut|
|Yale University School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Maksyn Minasyan 203-785-4177 firstname.lastname@example.org|
|Contact: Louise McLellan, RN 203-785-4177 email@example.com|
|Principal Investigator: Naftali Kaminski, MD|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Shanti Mangar 646-320-5303 firstname.lastname@example.org|
|Principal Investigator: Maria Padilla|
|Principal Investigator:||Gregory Downey, MD||National Jewish Health|
|Principal Investigator:||Annetine C Gelijns, PhD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Naftali Kaminski, MD||Yale University|