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Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

NCT04272645 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-07-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Ajjai Alva, MD · University of Michigan Rogel Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2022-10-31
Completion
2022-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04272645 on ClinicalTrials.gov