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PARP Inhibitor
Olaparib for Biliary Tract Cancer
Phase 2
Recruiting
Led By Daniel H Ahn
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological documentation of metastatic adenocarcinoma of the biliary tract
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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.
Who is the study for?
Adults with metastatic biliary tract cancer and specific DNA repair gene mutations can join. They must have a certain level of blood cells, organ function, and life expectancy over 16 weeks. Participants need to provide samples for research and not be pregnant or breastfeeding. Those with severe heart conditions, recent surgeries, uncontrolled infections or hypertension, prior PARP inhibitor treatment like olaparib, other cancers or treatments within the last month are excluded.Check my eligibility
What is being tested?
The trial is testing Olaparib's effectiveness on patients with advanced biliary tract cancer that has spread and who have abnormal DNA repair genes. It involves MRI and CT scans for monitoring tumor response to Olaparib which blocks enzymes needed by cancer cells to grow.See study design
What are the potential side effects?
Olaparib may cause side effects such as nausea, vomiting, fatigue, anemia (low red blood cell counts), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), digestive issues like indigestion or diarrhea, changes in taste sensation and risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer, originating in the bile ducts, has spread to other parts.
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My liver enzymes are within the required range for the trial.
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I have genetic changes linked to how my cells repair DNA.
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My cancer can be measured by tests.
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My kidneys are functioning well, with a creatinine clearance of at least 51 mL/min.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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My hemoglobin level is at least 9.0 g/dL and I haven't had a blood transfusion in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) at first scan
Secondary outcome measures
Duration of response (DoR)
Incidence of adverse events
Objective response rate
+2 moreOther outcome measures
Mutational signatures
Presence of mutations and mutational signatures
Prevalence of mutations
+2 moreSide effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib)Experimental Treatment4 Interventions
Patients receive olaparib PO BID on days 1-28. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI throughout the trial, and collection of blood and tissue samples on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,100 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,692 Previous Clinical Trials
40,929,970 Total Patients Enrolled
Daniel H AhnPrincipal InvestigatorAcademic and Community Cancer Research United
1 Previous Clinical Trials
22 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (olaparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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