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Ipatasertib + Abiraterone + Prednisone for Prostate Cancer (IPATential150 Trial)
IPATential150 Trial Summary
This trial is testing a new drug to see if it is effective and safe for people with mCRPC.
IPATential150 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIPATential150 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 242 Patients • NCT04177108IPATential150 Trial Design
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Who is running the clinical trial?
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- I cannot or will not swallow whole pills.I am immunocompromised due to HIV or I'm on immunosuppressive therapy.I have a history of serious heart rhythm problems or risk factors for them.I do not have any health conditions that would make it unsafe for me to take a new drug.I have not needed IV antibiotics for an infection in the last 14 days.I am fully active or restricted in physically strenuous activity but can do light work.My blood and organs are functioning well enough for treatment.I have a serious liver condition, including cirrhosis, alcohol abuse, or active hepatitis B or C.I take more than 10 mg/day of prednisone or equivalent for a chronic condition.I haven't had major surgery or a serious injury in the last 28 days and don't expect to need major surgery during the study.I haven't had any cancer except skin cancer or low-risk bladder cancer in the last 5 years.I have a condition that affects how my body absorbs food.You are expected to live for at least 6 more months.
- Group 1: Placebo + Abiraterone
- Group 2: Ipatasertib + Abiraterone
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 other large-scale tests have there been for Ipatasertib in the past?
"464 clinical trials are underway to test Ipatasertib. Out of those, 126 have reached Phase 3 status. The primary location for these studies is Duarte, California; though 20523 other locations across the globe are conducting similar research."
What are the goals of this particular clinical trial?
"The sponsor of this clinical trial, Hoffmann-La Roche, reports that the primary outcome being measured over a period of up to 31 months is Investigator-Assessed Radiographic Progression-Free Survival (rPFS) using PCWG3 criteria in the Intent-To-Treat population. Additionally, secondary outcomes being evaluated include plasma concentrations of abiraterone and ipatasertib at specified time points, as well as overall survival."
How many individuals are being given the opportunity to participate in this clinical trial?
"Unfortunately, this study is not recruiting at the moment. The listing was first created on June 30th, 2017 and updated October 28th, 2022. For those still seeking clinical trials, there are 1296 for prostate cancer and 464 for Ipatasertib that are actively looking for patients."
Could you please elucidate on any risks associated with Ipatasertib?
"Ipatasertib is classified as a Phase 3 drug, meaning that there have been multiple rounds of clinical trials with this medication and some data supporting efficacy. Power rates the safety of Ipatasertib as a 3."
Are new participants being enrolled in this experiment at this time?
"As of October 28th, 2022, this study is no longer recruiting patients. When the trial was first posted on June 30th, 2017, it had a different protocol. There are 1296 other studies currently looking for prostate cancer patients and 464 trials enrolling participants for Ipatasertib."
What condition does Ipatasertib help ameliorate?
"Ipatasertib is a medication that is frequently used to intervene in multiple sclerosis. Additionally, it has shown efficacy for treating ulcerative colitis, varicella-zoster virus acute retinal necrosis, and brain conditions."
Does this clinical trial have a large number of sites in the city?
"This study is being conducted in various locations across the United States, including but not limited to Miami Cancer Institute of Baptist Health, Inc. in Miami, Florida, Associates in Oncology/Hematology P.C. in Rockville, Maryland, and University of Michigan Comprehensive Cancer Center in Ann Arbor, Michigan among 42 other sites."
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