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Olaparib for Advanced Cancer
Study Summary
This trial will study a new drug to treat cancer that has progressed or been intolerant to standard of care therapy, and is positive for a certain gene mutation.
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 been diagnosed with MDS, AML, or conditions that suggest I might have them.My advanced cancer has no cure and standard treatments have failed.My breast cancer is due to a BRCA mutation.I am fully active or restricted in physically strenuous activity but can do light work.You are allergic to the ingredients in olaparib.I have an active hepatitis infection.My cancer is not breast or ovarian but has BRCA mutations, or it lacks BRCA and homologous recombination repair mutations.I have not taken any colony-stimulating factors in the last 28 days.My breast cancer has spread to other parts of my body.I am using or willing to use effective birth control or practice abstinence, and will not breastfeed during the study.I had radiotherapy over 2 weeks ago, have no side effects, and don't need steroids.I have had a bone marrow or cord blood transplant.I have been treated with olaparib or another PARP inhibitor before.I have been diagnosed with HIV.I have been treated with anthracycline and taxane for my cancer.I am a male and agree to use contraception and not donate sperm for 3 months and 5 days after my last treatment dose.I am not pregnant or breastfeeding.My cancer can be measured by standard imaging techniques.My cancer is hormone receptor-positive and has not responded to at least one hormone therapy.I have brain metastases but have been stable and off steroids for 14 days.My cancer has specific genetic changes related to how cells repair DNA.My cancer did not worsen while I was on platinum-based chemotherapy or within 4 weeks after finishing it.I have another cancer besides skin or early-stage cervical cancer that needed treatment in the last 5 years.I have not had a whole blood transfusion in the last 120 days.I have a harmful BRCA1 or BRCA2 mutation but not in my germline.I cannot take pills by mouth or have a condition that affects how my body absorbs medication.I haven't had cancer treatment like chemotherapy or hormone therapy in the last 3 weeks.I can provide a recent biopsy or an older tissue sample of my tumor.My primary cancer source is unknown.My organs are functioning well.
- Group 1: Olaparib
- 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
How many administrative hubs are overseeing this research trial?
"This study is currently recruiting participants from a total of 10 sites, such as St. Joseph Heritage Healthcare in Fullerton, Cancer Partners of Nebraska in Lincoln and Memorial Sloan Kettering Monmouth in Middletown; with 7 other places also included."
Does this experiment accept new participants at the present time?
"As it stands, this study is actively enrolling patients. Initial postings for the trial occured on December 12th 2018, with a most recent update occurring on November 17th 2022 according to clinicaltrials.gov."
What clinical indications has Olaparib been used to address?
"Olaparib is a commonly prescribed treatment for end-stage conditions. It has proven to be effective against malignant neoplasm of ovary, primary peritoneal cancer, and some hallucinatory afflictions."
What precedent have other experiments set when it comes to utilizing Olaparib?
"Presently, 188 clinical trials that involve Olaparib are being conducted. Of these ongoing investigations, 27 have progressed to Phase 3 of the study process. The majority of tests for this drug take place in Houston, Texas; however 9250 locations worldwide offer opportunities to participate in research about Olaparib's efficacy."
Is this a pioneering trial or have similar studies been done in the past?
"Currently, AstraZeneca has 188 ongoing studies of Olaparib in 59 countries and 1468 cities. Since its Phase 1 clinical trials began in 2005 with 98 participants, 63 additional investigations have been launched."
To what extent can Olaparib be detrimental to individuals?
"Our assessment of olaparib's safety was a 2, as this is currently in the Phase II stage with limited clinical evidence supporting its efficacy."
How many participants are actively engaging in this experiment?
"This medical trial requires 390 participants that meet the necessary qualifications. Patients can participate at St. Joseph Heritage Healthcare (Site 0056) in Fullerton, California or Cancer Partners of Nebraska ( Site 0051) in Lincoln, Nebraska."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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