CLINICAL TRIAL

Olaparib for Biliary Tract Cancer

Locally Advanced
Metastatic
Newly Diagnosed
Recruiting · 18+ · All Sexes · Scottsdale, AZ

This study is evaluating whether a drug may help treat cancer.

See full description

About the trial for Biliary Tract Cancer

Eligible Conditions
RAD51 Gene Mutation · ARID1A Gene Mutation · Fanconi Syndrome · Fanconi Anemia · BRCA 1 Gene Mutation · BRCA2 Gene Mutation · Biliary Tract Neoplasms · Bile Duct Adenocarcinoma · Fanconi Anemia Complementation Group Gene Mutation · EMSY Gene Mutation · ATM Gene Mutation · ATR Gene Mutation · CHEK2 Gene Mutation · PALB2 Gene Mutation · Carcinoma, Ductal · BRIP1 Gene Mutation · NBN Gene Mutation · MRE11 Gene Mutation · PTEN Gene Deletion · Metastatic Bile Duct Carcinoma

Treatment Groups

This trial involves 2 different treatments. Olaparib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Olaparib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved

Side Effect Profile for HRRm^

HRRm^
Show all side effects
59%
Nausea
47%
Fatigue
34%
Anaemia
31%
Vomiting
25%
Abdominal pain
22%
Diarrhoea
19%
Headache
19%
Dyspnoea
19%
Cough
16%
Dyspepsia
16%
Decreased appetite
13%
Constipation
13%
Urinary tract infection
13%
Dysgeusia
13%
Dizziness
9%
Abdominal pain lower
9%
Abdominal distension
9%
Blood creatinine increased
9%
Pain in extremity
9%
Back pain
9%
Rash
6%
Myalgia
6%
Deep vein thrombosis
6%
Pyrexia
6%
Gastrooesophageal reflux disease
6%
Nasopharyngitis
6%
Asthenia
6%
Oral candidiasis
6%
Respiratory tract infection
6%
Hypomagnesaemia
6%
Muscle spasms
6%
Alopecia
6%
Oropharyngeal pain
3%
Thrombocytopenia
3%
Mucosal inflammation
3%
Vertigo
3%
Myocardial infarction
3%
Gastroenteritis viral
3%
Femoral neck fracture
3%
Pleural effusion
3%
Pulmonary embolism
3%
Neutropenia
3%
Oedema peripheral
3%
Upper respiratory tract infection
3%
Alanine aminotransferase increased
3%
Neutrophil count decreased
3%
Platelet count decreased
3%
White blood cell count decreased
3%
Depression
3%
Insomnia
3%
Pruritus
0%
Personality change
0%
Foot fracture
0%
Anxiety
0%
Abdominal hernia
0%
Angina unstable
0%
Atrial fibrillation
0%
Mesenteric vein thrombosis
0%
Small intestinal obstruction
0%
Sudden death
0%
Colonic abscess
0%
Contrast media allergy
0%
Lower respiratory tract infection
0%
Sepsis
0%
Procedural pain
0%
Burkitt's lymphoma
0%
Papillary thyroid cancer
0%
Acute myeloid leukaemia
0%
Dysarthria
0%
Transient ischaemic attack
0%
Leukopenia
0%
Abdominal pain upper
0%
Influenza
0%
Influenza like illness
0%
Peripheral swelling
0%
Glomerular filtration rate decreased
0%
Arthralgia
0%
Musculoskeletal pain
0%
Taste disorder
0%
Irritability
Nausea
59%
Fatigue
47%
Anaemia
34%
Vomiting
31%
Abdominal pain
25%
Diarrhoea
22%
Headache
19%
Dyspnoea
19%
Cough
19%
Dyspepsia
16%
Decreased appetite
16%
Constipation
13%
Urinary tract infection
13%
Dysgeusia
13%
Dizziness
13%
Abdominal pain lower
9%
Abdominal distension
9%
Blood creatinine increased
9%
Pain in extremity
9%
Back pain
9%
Rash
9%
Myalgia
6%
Deep vein thrombosis
6%
Pyrexia
6%
Gastrooesophageal reflux disease
6%
Nasopharyngitis
6%
Asthenia
6%
Oral candidiasis
6%
Respiratory tract infection
6%
Hypomagnesaemia
6%
Muscle spasms
6%
Alopecia
6%
Oropharyngeal pain
6%
Thrombocytopenia
3%
Mucosal inflammation
3%
Vertigo
3%
Myocardial infarction
3%
Gastroenteritis viral
3%
Femoral neck fracture
3%
Pleural effusion
3%
Pulmonary embolism
3%
Neutropenia
3%
Oedema peripheral
3%
Upper respiratory tract infection
3%
Alanine aminotransferase increased
3%
Neutrophil count decreased
3%
Platelet count decreased
3%
White blood cell count decreased
3%
Depression
3%
Insomnia
3%
Pruritus
3%
Personality change
0%
Foot fracture
0%
Anxiety
0%
Abdominal hernia
0%
Angina unstable
0%
Atrial fibrillation
0%
Mesenteric vein thrombosis
0%
Small intestinal obstruction
0%
Sudden death
0%
Colonic abscess
0%
Contrast media allergy
0%
Lower respiratory tract infection
0%
Sepsis
0%
Procedural pain
0%
Burkitt's lymphoma
0%
Papillary thyroid cancer
0%
Acute myeloid leukaemia
0%
Dysarthria
0%
Transient ischaemic attack
0%
Leukopenia
0%
Abdominal pain upper
0%
Influenza
0%
Influenza like illness
0%
Peripheral swelling
0%
Glomerular filtration rate decreased
0%
Arthralgia
0%
Musculoskeletal pain
0%
Taste disorder
0%
Irritability
0%
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02476968) in the HRRm^ ARM group. Side effects include: Nausea with 59%, Fatigue with 47%, Anaemia with 34%, Vomiting with 31%, Abdominal pain with 25%.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Biliary Tract Cancer or one of the other 19 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Hemoglobin >= 9.0 g/dL with no blood transfusion in the past 28 days (obtained =< 7 days prior to registration)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) (obtained =< 7 days prior to registration)
Serum creatinine =< 1.5 x ULN (obtained =< 7 days prior to registration)
Histological or cytological documentation of metastatic adenocarcinoma of the biliary tract
Patients with previously identified genetic aberrations that are associated with homologous recombinant repair pathway will be eligible [e.g. somatic mutations in ATM, ATR, CHEK2, BRCA 1/2, RAD51, BRIP1, PALB2, PTEN, FANC, NBN, EMSY, MRE11, ARID1A] or germline mutations in the above genes. Clinical Laboratory Improvement Act (CLIA)-certified assays including commercial tests (Foundation Medicine, Caris, Tempus) will be allowed
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. (Form is available on the Academic and Community Cancer Research United [ACCRU] web site)
Life expectancy of >= 16 weeks per estimation of investigator Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 7 days prior to registration)
Platelet count >= 75,000/mm^3 (obtained =< 7 days prior to registration)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to registration)
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Olaparib will improve 1 primary outcome and 4 secondary outcomes in patients with Biliary Tract Cancer. Measurement will happen over the course of Up to 24 weeks after registration.

Best objective response rate
UP TO 24 WEEKS AFTER REGISTRATION
Will be defined as the percentage of patients with advanced biliary cancer treated with olaparib with aberrant deoxyribonucleic acid (DNA) repair/homologous recombination repair (HRR) genes, among evaluable patients, who had a response =< 24 weeks of registration. Response is defined as either complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
UP TO 24 WEEKS AFTER REGISTRATION
Progression-free survival (PFS)
FROM STUDY ENTRY TO THE FIRST OF EITHER DISEASE PROGRESSION OR DEATH FROM ANY CAUSE, ASSESSED UP TO 3 YEARS
Disease progression will be determined based on RECIST 1.1 criteria. PFS will be estimated using the Kaplan-Meier method. The median PFS and 95% confidence interval will be reported.
FROM STUDY ENTRY TO THE FIRST OF EITHER DISEASE PROGRESSION OR DEATH FROM ANY CAUSE, ASSESSED UP TO 3 YEARS
Overall survival (OS)
FROM STUDY ENTRY TO DEATH FROM ANY CAUSE, ASSESSED UP TO 3 YEARS
OS will be estimated using the Kaplan-Meier method. The median OS and 95% confidence interval will be reported.
FROM STUDY ENTRY TO DEATH FROM ANY CAUSE, ASSESSED UP TO 3 YEARS
Duration of response (DoR)
UP TO 3 YEARS
Will be defined for all evaluable patients who have achieved an objective response as the date at which the patient?s earliest best objective status is first noted to be either a complete response or partial response to the earliest date progression is documented, or death if no prior evidence of disease progression. The distribution of DoR will be estimated using the method of Kaplan-Meier (Kaplan and Meier 1958).
UP TO 3 YEARS
Incidence of adverse events
UP TO 3 YEARS
Adverse events by patient will be summarized by frequencies and severity using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
UP TO 3 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of biliary tract cancer?

The main signs of biliary tract cancer are jaundice, abdominal pain and weight loss. Jaundice typically appears over 2 weeks and is associated with fever. Stricture, gallstones and/ or lump may be visible as the tumour progresses. There is evidence of hepatocellular cancer in up to one third of patients which is associated with liver dysfunction and/ or decreased appetite.

Anonymous Patient Answer

What causes biliary tract cancer?

Chronic inflammation in the biliary tree is strongly associated with the development of hepatobiliary cancers. The role of bile acids may be particularly important in the development of carcinoma of the biliary tract in patients with primary sclerosing cholangitis for whom choledochoscopy is performed.

Anonymous Patient Answer

Can biliary tract cancer be cured?

Many patients and caregivers would appreciate the benefit of this study. Although it would appear that more patients would be eligible in the future, our main aim is to determine whether patients with this disease do in fact have longer survival rates once the disease is successfully treated. We hope that our findings will convince patients and their families that their life span can be prolongable by choosing to receive active treatment, even if they are not in a location that has an existing biliary tract cancer treatment centre. It is our hope that further studies that compare current and experimental treatment options for this disease will lead to improved treatment modalities and patient survival outcomes.

Anonymous Patient Answer

What is biliary tract cancer?

Biliary tract cancer is a disease that has been steadily increasing in incidence. In the developed world, it may become an important cause of death in the future. We suggest a definition for an early diagnosis of biliary tract cancer and an establishment of an accurate and precise diagnostic protocol for it.

Anonymous Patient Answer

How many people get biliary tract cancer a year in the United States?

Biliary tract cancer is relatively common (10,000 cases per year) in the US, representing 3-5% of all male liver cancer cases. In patients with resectable pancreatobiliary malignancies, a multimodality approach to chemoradiation resulted in an overall survival benefit similar to that demonstrated by the National Surgical Adjuvant Breast and Bowel Project (NSABP).

Anonymous Patient Answer

What are common treatments for biliary tract cancer?

Most common treatment options for biliary tract cancers include surgery, chemotherapy, radiation therapy and targeted therapy. Because of the limited data that exist on outcomes and cost-benefit analyses for all of these modalities for treating this disease, the use of specific surgical, radiation, and targeted therapies remain a contentious subject, and future studies will be required to adequately evaluate efficacy and cost-effectiveness for the management of biliary tract cancers.

Anonymous Patient Answer

Who should consider clinical trials for biliary tract cancer?

Although current treatment, such as a surgical resection or a transarterial chemoembolization, could be a palliative therapy, the median survival time is about 2 years. Because of the lack of sufficient evidence for its efficacy, clinical trials could provide more effective treatment.

Anonymous Patient Answer

Does biliary tract cancer run in families?

Findings from a recent study provides evidence that more than 80% (13 out of 16) of the families had a history of a second biliary tract cancer. If the occurrence of biliary tumor is a part of the autosomal dominant pattern we should consider a genetic study in families harboring biliary malignancies or a more complete gene analysis in those with only a family history of the disease.

Anonymous Patient Answer

How does olaparib work?

Olaparib inhibits progression to BCLC stage 1 HCC by blocking the ability of BCLC-C cells to invade blood vessels, which results in decreased tumor proliferation and angiogenesis. Further studies with more patients and longer durations of olaparib therapy are warranted.

Anonymous Patient Answer

What are the latest developments in olaparib for therapeutic use?

Olaparib has progressed smoothly to the point where its use, especially in combination with platinum-based chemotherapy, is now being widely adopted for the treatment of a variety of solid tumors.

Anonymous Patient Answer

Have there been any new discoveries for treating biliary tract cancer?

Until recent years, most of the treatment for patients with biliary cancer had been based on the principles of neoadjuvant treatment, in which preoperative treatment was given to reduce tumor size and staging, followed by surgical removal of the tumor, and finally adjuvant therapies. Today, we have many different adjuvant therapies that can help treat the disease; the main target of each individual therapy is to destroy metastases and shrink the primary tumor.

Anonymous Patient Answer

Does olaparib improve quality of life for those with biliary tract cancer?

In this first phase II, nonrandomised, open-label study, daily treatment with 240/300/400mg oral olaparib was well tolerated, and was associated with an improvement in HR-QoL, a measure of HRQoL, and cancer-related fatigue. Further studies are needed to confirm these findings among a large number of patients in phase III clinical trials.

Anonymous Patient Answer
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