NCT04272645

Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

A Phase II Multi-Center Trial of Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is studying two experimental drugs, abemaciclib and atezolizumab, alone and in combination with each other, to learn about the safety and effectiveness of these treatments and their side effects. This is an investigational study treatment for adult men with metastatic castrate resistant prostate cancer (mCRPC) who have progressive disease despite previous treatment with androgen deprivation therapy (ADT). One group of men (men without a genetic mutation called "CDK12 loss") will receive abemaciclib therapy alone. Two other groups of men (men with CDK12 loss in one group and men without CDK12 loss in the other) will receive the combination of abemaciclib and atezolizumab. Another group of men with CDK12 loss will receive atezolizumab therapy alone.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abemaciclib 200 MG	200 MG orally BID Days 1-21
DRUG	Atezolizumab 1200 MG in 20 ML Injection	1200 mg IV on Day 1 of 21-day cycle
DRUG	Abemaciclib 150 MG	150 MG orally BID Days 1-21

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2020-02-17
• Last updated: 2020-07-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study