Not yet recruiting
Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1)
I3Y-MC-JPCY - ClinicalTrials.gov - NCT04408924
The purpose of this study is to evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.
How long will I be in the trial?
Your participation could last up to 12 months depending on how you and your tumor respond.
Not yet recruiting
Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1)
I3Y-MC-JPCY - ClinicalTrials.gov - NCT04408924
The purpose of this study is to evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.
How long will I be in the trial?
Your participation could last up to 12 months depending on how you and your tumor respond.
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
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, Advanced Cancer, Metastatic Cancer, Solid Tumor
What the trial is testing?
Abemaciclib
Could I receive a Placebo?
no
Enrollment Goal
40
Trial Dates
December 2020 - March 2023
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
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, Advanced Cancer, Metastatic Cancer, Solid Tumor
What the trial is testing?
Abemaciclib
Could I receive a Placebo?
no
Enrollment Goal
40
Trial Dates
December 2020 - March 2023
Trial Phase
2
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Trial Locations
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