Active not recruiting

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

I3Y-MC-JPCM - ClinicalTrials.gov - NCT03706365

This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer.
How long will I be in the trial?
Your participation in this trial could last up to 40 months, depending on how you and your tumor respond.
Email
Active not recruiting

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

I3Y-MC-JPCM - ClinicalTrials.gov - NCT03706365

This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer.
How long will I be in the trial?
Your participation in this trial could last up to 40 months, depending on how you and your tumor respond.
Email

Key Requirements

Age :

18+

Sex:

Male

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

Male

Participants must

Participant must have diagnosis of prostate cancer that is metastatic

Participant must have prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant)

Participant must have documented evidence of progressive disease by imaging and/or PSA test

Participant must be willing to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research

Participants must NOT

Participant must not have received any of the following prior therapies: abiraterone acetate, abemaciclib, chemotherapy in the castration-resistant setting, radiopharmaceuticals, enzalutamide, apalutamide, darolutamide or sipuleucel-T

Participants must not have conditions that are not compatible with the clinical trial participation such as inability to swallow large pills, active or chronic liver disease, clinically significant heart disease, HIV, AIDS, active or uncontrolled clinically serious infection, or uncontrolled hypertension

Participant must not have brain metastases

Participant of reproductive potential must not father a child and must agree to use medically approved contraceptive precautions, and not donate sperm, during the study and for three months following the last dose of study drug

Trial Summary

Conditions the trial is for

Prostate Cancer, Solid Tumor

What the trial is testing?

Abemaciclib, Abiraterone Acetate, Prednisone, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

180

Trial Dates

November 2018 - February 2024

Trial Phase

2

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

Male

Participants must

Participant must have diagnosis of prostate cancer that is metastatic

Participant must have prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant)

Participant must have documented evidence of progressive disease by imaging and/or PSA test

Participant must be willing to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research

Participants must NOT

Participant must not have received any of the following prior therapies: abiraterone acetate, abemaciclib, chemotherapy in the castration-resistant setting, radiopharmaceuticals, enzalutamide, apalutamide, darolutamide or sipuleucel-T

Participants must not have conditions that are not compatible with the clinical trial participation such as inability to swallow large pills, active or chronic liver disease, clinically significant heart disease, HIV, AIDS, active or uncontrolled clinically serious infection, or uncontrolled hypertension

Participant must not have brain metastases

Participant of reproductive potential must not father a child and must agree to use medically approved contraceptive precautions, and not donate sperm, during the study and for three months following the last dose of study drug

Trial Summary

Conditions the trial is for

Prostate Cancer, Solid Tumor

What the trial is testing?

Abemaciclib, Abiraterone Acetate, Prednisone, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

180

Trial Dates

November 2018 - February 2024

Trial Phase

2

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?