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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)
Must not have
Concomitant use of known strong or moderate CYP3A inducers
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how well olaparib works in patients with advanced biliary tract cancer and specific DNA repair gene mutations. Olaparib may help stop cancer growth by blocking enzymes needed for cell repair. The trial aims to see if this treatment can improve survival and response rates.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any strong or moderate drugs that affect liver enzymes.
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I understand the study drug's effects on unborn babies are unknown.
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I have not had major surgery or a serious injury in the last 28 days.
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I am immunocompromised or HIV positive and on antiretroviral therapy.
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I have previously been treated with a PARP inhibitor.
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I am experiencing moderate to severe dehydration.
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I require dialysis for kidney failure.
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I have a condition that affects how my body absorbs medication.
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I have been diagnosed with MDS/AML or show signs of it.
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I have or had a pheochromocytoma.
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I currently have symptoms of interstitial lung disease.
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I haven't had serious bleeding issues in the last month.
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I have heart failure that affects my daily activities.
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I am on medication that affects my heart's rhythm.
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I have fluid in my chest or abdomen causing significant breathing problems.
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My blood pressure is not controlled and is considered severe.
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I am on medication for seizures.
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My condition did not improve after platinum-based chemotherapy.
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I cannot take medicine by mouth.
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I have a wound, ulcer, or bone fracture that hasn't healed.
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I do not have a serious ongoing infection.
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I have had an organ transplant, bone marrow transplant, or cord blood transplantation.
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I am not taking strong or moderate CYP3A inhibitors.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival (PFS) at first scan
Secondary study objectives
Duration of response (DoR)
Incidence of adverse events
Objective response rate
+2 moreOther study objectives
Mutational signatures
Presence of mutations and mutational signatures
Prevalence of mutations
+1 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%
Dizziness
9%
Aspartate aminotransferase increased
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Olaparib
2007
Completed Phase 4
~2190
Biospecimen Collection
2004
Completed Phase 3
~2030
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for bile duct cancer include chemotherapy, targeted therapy, and PARP inhibitors like Olaparib. Chemotherapy drugs, such as gemcitabine and cisplatin, work by damaging the DNA of cancer cells, preventing them from dividing and growing.
Targeted therapies, like FGFR inhibitors, block specific molecules involved in cancer cell growth and survival. PARP inhibitors, such as Olaparib, prevent the repair of single-strand DNA breaks in cancer cells with defective DNA repair mechanisms, leading to cell death.
These treatments are significant for bile duct cancer patients as they offer tailored approaches that can improve outcomes, especially in those with specific genetic mutations.
Combining biological agents and chemotherapy in the treatment of cholangiocarcinoma.
Combining biological agents and chemotherapy in the treatment of cholangiocarcinoma.
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
4,905 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,943 Previous Clinical Trials
41,024,667 Total Patients Enrolled
104 Trials studying Liver Cancer
26,538 Patients Enrolled for Liver Cancer
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.