Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

August 9, 2023

Primary Completion Date

July 15, 2025

Study Completion Date

June 1, 2026

Conditions
Metastatic Prostate CancerNon-metastatic Prostate CancerProstate Cancer
Interventions
DRUG

Darolutamide

Tablet administered orally, per protocol, 2 x daily. Darolutamide is an orally administered molecular drug therapy that blocks the action of testosterone, the male sex hormone which can stimulate growth of prostate cancer.

DRUG

Abemaciclib

"Tablet administered orally, per protocol, 2 x daily. Abemaciclib is an orally administered molecular drug therapy that is called a CDK4/6 inhibitor. CDK4 and CDK6 are enzymes that are involved in helping healthy and cancerous cells divide and blocking these enzymes can stop cancerous cells from growing."

DRUG

GNRH-A Leuprolide Acetate

Administered via intramuscular injection, per standard of care. GnRH agonist is a hormonal therapy drug.

DRUG

GNRH-A Goserelin

Administered via subcutaneous injection, per standard of care. GnRH agonist is a hormonal therapy drug.

DRUG

Degarelix

Administered via subcutaneous injection, per standard of care. GnRH antagonist is a hormonal therapy drug.

Trial Locations (1)

02215

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

collaborator

Bayer

INDUSTRY

lead

Praful Ravi, MB BCHir, MRCP

OTHER

NCT05617885 - Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer | Biotech Hunter | Biotech Hunter