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Olaparib for Advanced Cancer
Study Summary
This trial will study how well olaparib works in treating patients with certain types of cancer that have spread and usually cannot be controlled with treatment. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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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- My kidneys are functioning well enough, based on a specific test.I am willing and able to follow the study's treatment plan and attend all visits.I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I do not have any serious, uncontrolled health issues or infections.I have active hepatitis B or C.I have had a bone marrow or double cord blood transplant.I cannot swallow pills or have stomach issues affecting medication absorption.My tumor has an IDH1 or IDH2 mutation and has not responded to standard treatments.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.I have never been treated with a PARP inhibitor like olaparib.I have not had a blood transfusion in the last 4 months.I understand this trial and can consent, or have someone who can consent for me.I have not had any other cancer in the last 5 years, except for certain types.My heart's electrical activity or my family has a history of abnormal rhythms.I am not taking any strong or moderate drugs that affect liver enzymes.I have brain metastases that are causing symptoms and are not under control.My glioma has come back or gotten worse, and I haven't had surgery or radiation in the last 3 weeks.I haven't had radiation therapy in the last 3 weeks.I am mostly self-sufficient and can carry out daily activities.I have never taken the study drug or any PARP inhibitors before.I am using or will use effective birth control during and for 1 month after the study.I am a man who will use two effective birth control methods during and 3 months after the study.My MRI shows my brain tumor is growing.My cancer is getting worse, and I haven't had certain treatments for at least 30 days.I had major surgery more than 2 weeks ago and have mostly recovered.My high-grade brain tumor has worsened within 12 weeks after finishing chemoradiotherapy.I have a tumor outside the brain that can be measured or tracked over time.My high-grade brain tumor has worsened 12 weeks after finishing treatment.My tumor can be easily biopsied, and I agree to multiple biopsies.My side effects from past cancer treatments are mild, except for hair loss or stable long-term effects.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.I am 18 years old or older.I am not taking strong or moderate CYP3A inhibitor medications.My cancer's progress can be measured by specific medical criteria.My WHO grade II glioma has progressed according to specific criteria.
- Group 1: Treatment (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
What supplementary investigations have been performed utilizing Olaparib?
"Olaparib first underwent clinical trials in 2005 at Research Site, with 63 studies having been completed since. Currently, 188 active trials are being carried out across the United States of America - many of which originated from Overland Park, Kansas."
How many subjects are being included in this medical research?
"In order to complete the study, 145 eligible participants are needed. The research will take place at two University of Kansas locations: Hospital-Indian Creek Campus in Overland Park and Westwood Cancer Center in Westwood."
Is this experiment pathbreaking in its approach?
"Olaparib has been under clinical study since 2005, with the first trial sponsored by AstraZeneca. After its Phase 1 approval in 2005 following a 98-patient sample size evaluation, there are presently 188 ongoing trials of Olaparib spread over 1468 cities and 59 countries worldwide."
In what quantity of medical establishments is this experiment being conducted?
"This clinical trial is currently being offered from 34 different sites, including Overland Park, Westwood and Nashville. To reduce the need for long-distance travel during your participation in this study, we recommend selecting a site close to you."
Are new participants being enrolled in this medical experiment?
"Affirmative. According to the clinical trials website, this medical experiment is currently recruiting participants. Initially posted on March 30th 2018 and most recently updated October 18th 2022, 145 patients are needed from 34 sites across the country."
To what extent can patients rely on Olaparib to be secure?
"The safety rating for Olaparib was 2, as the Phase 2 trial has yet to produce any evidence of efficacy. This score is based on existing data that points towards its safety."
What pathologies can be ameliorated through the utilization of Olaparib?
"Olaparib is used to treat a range of maladies, including advance directives and the cancerous growths in the ovary or peritoneum. Additionally, it can be effective against hallucinations, somatic."
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