# A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

> **NCT05288166** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Eli Lilly and Company** · enrollment: 925 (actual)

## Conditions studied

- Prostatic Neoplasms
- Neoplasm Metastasis
- Urogenital Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Androgens
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Abiraterone Acetate
- Steroid Synthesis Inhibitors
- Cytochrome P-450
- Enzyme Inhibitors
- Prednisone
- Prednisolone
- Cyclin-Dependent Kinase 4
- Cyclin-Dependent Kinase 6

## Interventions

- **DRUG:** Abemaciclib
- **DRUG:** Abiraterone
- **DRUG:** Prednisone or Prednisolone
- **DRUG:** Placebo for Abemaciclib

## Key facts

- **NCT ID:** NCT05288166
- **Lead sponsor:** Eli Lilly and Company
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-04-14
- **Primary completion:** 2024-02-15
- **Final completion:** 2027-10
- **Target enrollment:** 925 (ACTUAL)
- **Last updated:** 2025-06-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05288166

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05288166, "A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT05288166. Licensed CC0.

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