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Galunisertib + Enzalutamide for Prostate Cancer
Study Summary
This trial is testing if adding LY2157299 to enzalutamide helps people with metastatic castration-resistant prostate cancer live longer without their disease getting worse.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 132 Patients • NCT02178358Trial Design
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Who is running the clinical trial?
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- I have been treated with enzalutamide, ARN-509, or galeterone.I am 18 years old or older.I have or had brain metastases.I have a history of an autoimmune disease like Crohn's, lupus, or multiple sclerosis.I received hormonal therapy for my condition within the last 2 weeks.I can do all my daily activities without help.I agree to have a tumor biopsy before and during treatment if it's safe.I do not have any severe illnesses that could interfere with the study.My prostate cancer has spread and is not responding to hormone therapy.I have been treated with abiraterone before.I have had chemotherapy for prostate cancer that did not respond to hormone therapy.I had surgery less than 4 weeks before starting the study drug.I have had a seizure before.I haven't taken systemic steroids in the last week.I haven't had cancer treatment like radiation or experimental drugs in the last 2 weeks.I have a serious heart condition.I can take pills by mouth.My organ and bone marrow functions meet the required levels.You are expected to live for at least 3 more months.I have a history of HIV, hepatitis B, or hepatitis C.
- Group 1: Arm 1: Enzalutamide with LY2157299
- Group 2: Arm 2: Enzalutamide alone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the official stance of the FDA on LY2157299?
"LY2157299's score of 2 on a scale from 1 to 3 comes from being in Phase 2 clinical trials. While there is evidence that the medication is safe, its efficacy has not yet been studied."
Are people with the target condition able to enroll in this research project at this time?
"Yes, an updated check of the clinicaltrials.gov website shows that this study is still seeking participants. This trial was first publicized on May 3rd, 2016 and was most recently updated on June 1st, 2022. The research team hopes to enroll 60 patients total at three different locations."
Are there any other ongoing studies that include LY2157299?
"There are currently one hundred and nine clinical trials underway for LY2157299 with thirty of them in the third phase. Out of the five thousand seven hundred and eighty-three locations conducting these studies, several are based in Germantown, Tennessee."
Will this research be extending to patients that are beyond the age of 50?
"The age bracket for this study starts at 18 years old and ends at 100 years old."
Which patients fit the screening criteria for this experiment?
"The prerequisites for this study are that the patient has prostate cancer and is between 18-100 years old. Currently, the researchers conducting this trial 60 individuals to test their hypothesis."
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