NCT06190899 - Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2027

Conditions

mCRPC (Metastatic Castration-resistant Prostate Cancer)Genital Diseases, MaleUrogenital Diseases, MaleProstatic DiseaseProstatic Neoplasms, Castration-ResistantProstate Cancer

Interventions

DRUG

Gedatolisib

Gedatolisib is a potent reversible inhibitor that selectively targets all Class I PI3K isoforms and mTOR.

DRUG

Darolutamide

Darolutamide is a novel androgen receptor inhibitor that has been studied and received approval for treatment of patients with nonmetastatic CRPC and in metastatic hormone-sensitive prostate cancer.

Trial Locations (13)

13009

NOT_YET_RECRUITING

Institut Paoli-Calmettes, Marseille

28007

NOT_YET_RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

28045

RECRUITING

Hospital 12 de Octubre, Madrid

46009

NOT_YET_RECRUITING

Instituto Valenciano de Oncología, Valencia

48201

RECRUITING

Barbara Ann Karmanos Cancer Institute, Detroit

63011

NOT_YET_RECRUITING

Centre Jean Perrin, Clermont-Ferrand

94805

NOT_YET_RECRUITING

Institut Gustave Roussy, Villejuif

06100

NOT_YET_RECRUITING

Centre Antoine Lacassagne, Nice

08036

RECRUITING

Hospital Clinic Barcelona, Barcelona

08908

RECRUITING

Institut Catala d'Oncologia, Barcelona

CB20QQ

NOT_YET_RECRUITING

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospita, Cambridge

SO16 6YD

NOT_YET_RECRUITING

University Hospital Southampton NHS Foundation Trust - Southampton General Hospital, Southampton

SM25PT

RECRUITING

Royal Marsden NHS Foundation Trust, Sutton