NCT02874989: IPF

Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial

Completed Phase 1 Last updated 12 May 2020

What this trial tests

Phase 1 trial testing Dasatinib + Quercetin in Idiopathic Pulmonary Fibrosis (IPF) in 26 participants. Completed in 3 June 2019.

Timeline

16 December 2016

Primary endpoint
3 June 2019

3 June 2019

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	26
Start date	16 December 2016
Primary completion	3 June 2019
Estimated completion	3 June 2019
Sites	2 locations across United States

Drugs / interventions tested

• Dasatinib + Quercetin — full drug profile →
• Placebo

Conditions studied

• Idiopathic Pulmonary Fibrosis (IPF) — all drugs for Idiopathic Pulmonary Fibrosis (IPF) →

Sponsor

Wake Forest University Health Sciences

Who can join

50 and older, any sex, with Idiopathic Pulmonary Fibrosis (IPF). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study team hypothesizes that intermittent (3 doses administered over 3 consecutive days in 3 consecutive weeks) oral administration of combination Dasatinib (100 mg/d) + Quercetin (1250 mg/d) will be safe and well tolerated in patients with IPF. Treatment with D+Q will result in reduced abundance of pro-inflammatory cells within subjects over baseline. Finally, the reduction in biomarkers of cellular pro-inflammatory state will be related to no change in functional and patient reported outcomes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Senolytics decrease senescent cells in humans: Preliminary report from a clinical trial of Dasatinib plus Quercetin in individuals with diabetic kidney disease.
   Hickson LJ, Langhi Prata LGP, Bobart SA, Evans TK, et al · · 2019 · cited 972× · PMID 31542391 · DOI 10.1016/j.ebiom.2019.08.069
2. Senolytics in idiopathic pulmonary fibrosis: Results from a first-in-human, open-label, pilot study.
   Justice JN, Nambiar AM, Tchkonia T, LeBrasseur NK, et al · · 2019 · cited 915× · PMID 30616998 · DOI 10.1016/j.ebiom.2018.12.052
3. Cellular senescence and senolytics: the path to the clinic.
   Chaib S, Tchkonia T, Kirkland JL. · · 2022 · cited 818× · PMID 35953721 · DOI 10.1038/s41591-022-01923-y
4. Idiopathic pulmonary fibrosis: Disease mechanisms and drug development.
   Spagnolo P, Kropski JA, Jones MG, Lee JS, et al · · 2021 · cited 448× · PMID 33359599 · DOI 10.1016/j.pharmthera.2020.107798
5. Cellular senescence: a key therapeutic target in aging and diseases.
   Zhang L, Pitcher LE, Yousefzadeh MJ, Niedernhofer LJ, et al · · 2022 · cited 429× · PMID 35912854 · DOI 10.1172/jci158450
6. Therapy-Induced Senescence: Opportunities to Improve Anticancer Therapy.
   Prasanna PG, Citrin DE, Hildesheim J, Ahmed MM, et al · · 2021 · cited 264× · PMID 33792717 · DOI 10.1093/jnci/djab064
7. Senolytic Drugs: Reducing Senescent Cell Viability to Extend Health Span.
   Robbins PD, Jurk D, Khosla S, Kirkland JL, et al · · 2021 · cited 231× · PMID 32997601 · DOI 10.1146/annurev-pharmtox-050120-105018
8. Targeting senescent cells in translational medicine.
   Paez-Ribes M, González-Gualda E, Doherty GJ, Muñoz-Espín D. · · 2019 · cited 230× · PMID 31746100 · DOI 10.15252/emmm.201810234