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Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

NCT05999968 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-05

No results posted yet for this study

Summary

The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after initial treatment. Participation may last up to 32 months.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

LHRH agonist/antagonist

Physician's choice. Administered in accordance with the prescribing information.

DRUG

Abemaciclib

Administered orally.

DRUG

Darolutamide

Administered orally.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2024-02-23
Completion
2026-01-21
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05999968 on ClinicalTrials.gov