Evaluation of (R)-Roscovitine Safety and Effects in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Summary

This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled study. The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa. This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.

Timeline

Start

2016-02-22

Primary completion

2018-07-26

Completion

2018-07-26

Publications

• Results Meijer L, Hery-Arnaud G, Leven C, Nowak E, Hillion S, Renaudineau Y, Durieu I, Chiron R, Prevotat A, Fajac I, Hubert D, Murris-Espin M, Huge S, Danner-Boucher I, Ravoninjatovo B, Leroy S, Macey J, Urban T, Rault G, Mottier D, Berre RL. Safety and pharmacokinetics of Roscovitine (Seliciclib) in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa, a randomized, placebo-controlled study. J Cyst Fibros. 2022 May;21(3):529-536. doi: 10.1016/j.jcf.2021.10.013. Epub 2021 Dec 24.

Drugs

Indications