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Olaparib + Vorinostat for Breast Cancer
Study Summary
This trial is testing the safety and effectiveness of two drugs, olaparib and vorinostat, when used together to treat breast cancer that has returned or spread.
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 2023 Phase 3 trial • 154 Patients • NCT02184195Trial Design
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Who is running the clinical trial?
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- I have not had major surgery in the last 4 weeks.I do not have any severe health issues that could interfere with the study.My breast cancer has returned or spread and is not HER2-positive.I am 18 years old or older.I have stopped taking any medications that affect my heart's rhythm for 2 weeks.I have severe heart issues or chest pain.I have a condition like diabetes, Parkinson's, HIV, liver disease, thyroid issues, or heart failure that might affect my heart's rhythm.I am willing to have a biopsy for the study.You have a disease that can be measured using a specific medical guideline called RECIST 1:1.I am a male and agree to use condoms during the study and for 3 months after.I am postmenopausal or not able to bear children, confirmed by a recent negative pregnancy test.I cannot take pills by mouth or have stomach issues that affect medication absorption.I haven't had chemotherapy or radiation in the last 4 weeks.I have a serious heart rhythm problem or had a recent heart attack.I am fully active or restricted in physically strenuous activity but can do light work.I am allergic to olaparib, vorinostat, or similar medications.I have lung inflammation or am at risk for it.I do not have uncontrolled brain cancer spread.I have had a bone marrow or double cord blood transplant.I am not taking strong or moderate drugs that affect liver enzymes.You are expected to live for at least 6 more months.My organ and bone marrow functions are normal as tested within the last 28 days.I have lasting side effects from cancer treatment, but not hair loss.I do not have an active infection and am not known to be HIV positive.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.I have conditions that could cause heart rhythm problems.I have not had a blood transfusion in the last 4 months.I am not taking any strong or moderate drugs that affect liver enzymes.I have a history of liver disease, like cirrhosis or hepatitis B/C.I have never been treated with PARP or HDAC inhibitors.I have no active cancer except for certain skin cancers, cervical cancer in place, or any cancer I've been free from for over 5 years.
- Group 1: Olaparib and Vorinostat
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 risk profile for Olaparib usage?
"Olaparib's safety was rated a 1, as there is limited evidence to demonstrate its efficacy and little data to confirm it is safe."
What afflictions may be addressed with Olaparib?
"Olaparib can be therapeutically applied to cases of advanced cutaneous T-cell lymphoma, ctage1 protein, human physiology and pharmacological treatments."
Have any investigations been carried out with Olaparib in the past?
"At this time, there are 217 trials involving Olaparib. Of these studies, 29 of them are in their final phase. The primary location for such research is Phoenix, Arizona; however a multitude of other sites also offer the experimental treatment to participants."
What is the number of participants that have been recruited to this research endeavor?
"Indeed, the clinical trial's page on clinicaltrials.gov reveals that recruitment is still ongoing for this medical experiment which was first posted in June 2019 and has been updated recently in August 2022. 28 people are sought out from a single site to take part in it."
Has this experiment previously been conducted?
"Currently, 217 clinical trials pertaining to Olaparib are happening across 1523 cities and 60 countries. This drug was first introduced in a 2005 AstraZeneca-led trial involving 98 patients and successfully completed Phase 1 of the approval process. Subsequently, 204 other experiments have been finalized since then."
Is this research endeavor still open to new participants?
"Based on recently updated records from clinicaltrials.gov, this experimental trial is presently in search of suitable participants. It was initially published on June 11th 2019 and revised most recently on August 5th 2022."
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