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

PHASE2TerminatedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

February 22, 2016

Primary Completion Date

July 26, 2018

Study Completion Date

July 26, 2018

Conditions
Cystic Fibrosis
Interventions
DRUG

Roscovitine

Roscovitine is an experimental drug candidate in the family of pharmacological cyclin-dependent kinase (CDK) inhibitors that preferentially inhibit multiple enzyme targets including CDK2, CDK7 and CDK9. Seliciclib is a 2,6,9-substituted purine analog.

DRUG

Placebo

The placebo treatment is lactose capsule.

Trial Locations (11)

29684

Centre de Perharidy, Roscoff

30030

Hôpital Larrey, Toulouse

33604

CHU de Bordeaux - Hôpital Haut-Lévêque, Pessac

34295

Hôpital Arnaud de Villeneuve, Montpellier

44093

CHU Nantes, Nantes

51100

Centre de Ressources et de Compétences de la mucoviscidose, Reims

56017

Centre Hospitalier Bretagne Atlantique, Vannes

59037

CHR - Hôpital Calmette, Lille

69495

CH Lyon Sud, Lyon

75014

Hôpital Cochin, Paris

06001

CHU de Nice - Hôpital Pasteur, Nice

All Listed Sponsors
collaborator

ManRos Therapeutics

UNKNOWN

collaborator

Cyclacel Pharmaceuticals, Inc.

INDUSTRY

lead

University Hospital, Brest

OTHER

NCT02649751 - Evaluation of (R)-Roscovitine Safety and Effects in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Biotech Hunter | Biotech Hunter