Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT04272645
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 31, 2020
Status verified
Jul 2020
Primary completion
Oct 31, 2022
Completion
Oct 31, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - Abemaciclib 200 mg
    Abemaciclib twice daily. 1 cycle of treatment is 21 days in length.
  • Experimental: Arm B - Abemaciclib 150 mg + atezolizumab
    Atezolizumab on the first day of each 21-day cycle in combination with abemaciclib twice daily.
  • Experimental: Experimental: Arm C - Patients with CDK12 loss
    Group 1 - Atezolizumab: Patients with CDK12 loss will receive atezolizumab monotherapy on the first day of each 21-day cycle Group 2 - Abemaciclib 150 mg + atezolizumab: Patients with CDK12 loss will receive atezolizumab on the first day of each 21-day cycle in combination with abemaciclib twice daily.

Primary Outcome Measure

Progression free survival (PFS) (Arms A and B) [ Time Frame: 6 months after start of treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of MinnesotaMinneapolisMinnesota55455-
Washington University - St. LouisSt LouisMissouri63130-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Dana-Farber Cancer Institute· Boston, MAUniversity of Minnesota· Minneapolis, MNWashington University - St. Louis· St Louis, MOThomas Jefferson University· Philadelphia, PA

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