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Olaparib for Biliary Tract Cancer
Study Summary
This trial is testing olaparib to treat patients with biliary tract cancer that has spread and who have aberrant DNA repair gene mutations. 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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- Women who can have children need to have a negative pregnancy test before starting the treatment.I haven't had cancer treatment or tumor-targeting procedures in the last 28 days.I am not taking any strong or moderate drugs that affect liver enzymes.I have not had a blood transfusion in the last 4 months.I understand the study drug's effects on unborn babies are unknown.I have not had major surgery or a serious injury in the last 28 days.My cancer, originating in the bile ducts, has spread to other parts.Your kidney function, measured by a blood test, is within the normal range.My liver enzymes are within the required range for the trial.I am immunocompromised or HIV positive and on antiretroviral therapy.I have previously been treated with a PARP inhibitor.I am experiencing moderate to severe dehydration.I require dialysis for kidney failure.I have a condition that affects how my body absorbs medication.I have been diagnosed with MDS/AML or show signs of it.I have or had a pheochromocytoma.I currently have symptoms of interstitial lung disease.I haven't had serious bleeding issues in the last month.I have had hepatitis B and am being monitored during cancer treatment.I have genetic changes linked to how my cells repair DNA.I am on antiviral therapy for chronic HBV while receiving cancer treatment.My cancer can be measured by tests.Your alkaline phosphatase levels should not be more than 2.5 times the upper limit of normal. If your liver is affected by cancer, the limit is 5 times the upper limit of normal.I have heart failure that affects my daily activities.My kidneys are functioning well, with a creatinine clearance of at least 51 mL/min.I am on medication that affects my heart's rhythm.I don't have severe side effects from previous treatments, except for hair loss or mild nerve damage.You have had a bad reaction to olaparib or any of the ingredients in the product.I have brain or meningeal tumors but have been stable for over 6 months after treatment.I have fluid in my chest or abdomen causing significant breathing problems.I haven't had a stroke, clot in my leg or lung clot in the last 6 months.You have very high levels of protein in your urine.I am 18 years old or older.My blood pressure is not controlled and is considered severe.I am on medication for seizures.My condition did not improve after platinum-based chemotherapy.Your total bilirubin level is less than or equal to 1.5 times the upper limit of normal.I cannot take medicine by mouth.I have a wound, ulcer, or bone fracture that hasn't healed.I can take care of myself and am up and about more than half of my waking hours.I am currently taking medications or herbal products.You have markers of hepatitis B virus in your blood.You have a sufficient number of a type of white blood cell called neutrophils.I do not have a serious ongoing infection.You have had other cancers in the past or currently have other cancers.I have had an organ transplant, bone marrow transplant, or cord blood transplantation.Your albumin levels are less than 2.5 grams per deciliter.I am not taking strong or moderate CYP3A inhibitors.Your blood clotting time is within a normal range.Your platelet count is at least 75,000 per cubic millimeter.My hemoglobin level is at least 9.0 g/dL and I haven't had a blood transfusion in the last 28 days.
- 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 are some similar studies that have been done with Olaparib?
"Olaparib was first evaluated in a clinical setting in 2005. As of now, there have been 63 completed trials with 198 more ongoing. Many of these live studies are based in Jacksonville, Florida."
What are the main indications for Olaparib?
"Olaparib is frequently used to treat patients with terminal illnesses. It can also be effective for cancer of the ovary, primary peritoneal cancer, and hallucinations."
Are there any adverse effects associated with Olaparib?
"Given that this is a Phase 2 trial, meaning that while there is some safety data there is none currently supporting efficacy, our team has estimated the safety of Olaparib to be a 2."
Are new participants currently being enrolled in this research?
"Yes, this is an active trial that was posted on clinicaltrials.gov on 6/9/2020 and updated as recently as 5/5/2022. The study requires 36 participants who will be recruited from 5 different sites."
Do we have any previous data to compare these results to?
"Since 2005, when the first study was completed, there has been an explosion in the number of clinical trials for Olaparib. In fact, 198 different medical studies are currently underway across 59 nations and 1462 cities."
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