Your session is about to expire
← Back to Search
Olaparib for Pancreatic Cancer
Phase 2
Recruiting
Led By Kim A Reiss Binder
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing whether adding olaparib after surgery and chemo helps treat pancreatic cancer with a pathogenic mutation in BRCA1, BRCA2, or PALB2.
Who is the study for?
This trial is for adults in the US with resected pancreatic cancer and a BRCA1, BRCA2, or PALB2 mutation. They must have completed surgery and chemotherapy without recurrence of cancer. Participants need adequate blood counts, no serious medical conditions, not be on certain drugs that affect metabolism, and can't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests if olaparib after surgery and chemo extends survival in patients with specific genetic mutations linked to pancreatic cancer. Olaparib blocks an enzyme involved in DNA repair which may prevent tumor cells from surviving. Patients are randomly assigned to receive either olaparib or a placebo.See study design
What are the potential side effects?
Olaparib may cause side effects like nausea, fatigue, anemia (low red blood cell count), vomiting, diarrhea, loss of appetite, taste changes, indigestion and headache. It might also lead to more serious conditions such as lung problems (pneumonitis) or secondary cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
Select...
I had surgery for pancreatic cancer and currently show no signs of the cancer returning.
Select...
I am 18 years old or older.
Select...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
My hemoglobin level is at least 9.0 g/dL without recent blood transfusions.
Select...
I agree to genetic testing if my cancer has specific mutations.
Select...
I am not taking strong medications like ketoconazole or ritonavir.
Select...
I can understand and am willing to sign the consent form, or have someone legally authorized to do so on my behalf.
Select...
My pancreatic cancer did not worsen while I was on platinum-based therapy.
Select...
I do not have any serious health issues that are not under control.
Select...
I had surgery for pancreatic cancer and currently show no signs of the cancer returning.
Select...
I have a confirmed harmful mutation in BRCA1, BRCA2, or PALB2.
Select...
My scans show no signs of pancreatic cancer spread as of the last 4 weeks.
Select...
My hepatitis B virus load is undetectable with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in relapse-free survival (RFS)
Secondary outcome measures
Differences in survival
Efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation
OS in those who received =< 3 months of perioperative platinum chemotherapy versus > 3 months of perioperative platinum chemotherapy
+5 moreOther outcome measures
RFS and OS differences in patients who had R1 vs R0 resections
CA-19-9 Antigen
RFS and OS differences in patients who had lymph node positivity at resection
+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%
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (olaparib)Experimental Treatment4 Interventions
Patients receive olaparib PO BID on days 1-28 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans or CT/MRI and collection of blood throughout the study.
Group II: Arm II (placebo)Placebo Group4 Interventions
Patients receive placebo PO BID on days 1-28 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans or CT/MRI and collection of blood throughout the 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?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,650 Total Patients Enrolled
Kim A Reiss BinderPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or will have at least 3 months of chemotherapy around the time of my surgery.I have recovered from side effects of previous cancer treatments, except for hair loss or nerve issues.I am undergoing or have completed up to 6 months of chemotherapy around the time of my surgery.I am able to get out of my bed or chair and move around.I had surgery for pancreatic cancer and currently show no signs of the cancer returning.My last cancer treatment was within the last 12 weeks.I am 18 years old or older.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am not currently being treated for another cancer, except for hormone or skin cancer treatments.I do not have any serious health issues that are not under control.My hemoglobin level is at least 9.0 g/dL without recent blood transfusions.Inclusion criteria: Patient has been hospitalized for an acute illness or injury.I agree to genetic testing if my cancer has specific mutations.An expert has reviewed my genetic test results and found me eligible.Your white blood cell count is at least 3,000 per microliter. This will be checked within 28 days before starting the trial.I am HIV positive, on treatment, and my viral load is undetectable.I am not taking strong medications like ketoconazole or ritonavir.I do not have a neuroendocrine tumor.I do not have any severe stomach or bowel problems that would affect medication absorption.I have never had myelodysplastic syndrome or acute myeloid leukemia.I can understand and am willing to sign the consent form, or have someone legally authorized to do so on my behalf.My pancreatic cancer did not worsen while I was on platinum-based therapy.Your white blood cell count is at least 1,500 per microliter.Your ECG doesn't show serious heart problems that can be fixed, and you don't have congenital long QT syndrome.I haven't had major surgery in the last 2 weeks and have recovered from any past surgeries.I've had 3 to 6 months of chemotherapy around the time of my surgery.I had surgery for pancreatic cancer and currently show no signs of the cancer returning.Your platelet count is at least 100,000 per microliter within the last 28 days before the start of the study.I have a confirmed harmful mutation in BRCA1, BRCA2, or PALB2.My scans show no signs of pancreatic cancer spread as of the last 4 weeks.It's been 3 to 12 weeks since my last cancer treatment.Your bilirubin levels should be within a certain range, unless you have Gilbert's syndrome. If you have Gilbert's syndrome, a different bilirubin level is allowed.Your AST and ALT levels should be within a certain range when tested within 28 days before starting the study.My kidney function tests are within normal limits.My hepatitis B virus load is undetectable with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (olaparib)
- Group 2: Arm II (placebo)
Awards:
This trial has 0 awards, including: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 purpose does Olaparib serve therapeutically?
"Olaparib is typically used to treat advanced cancers, such as malignant neoplasm of ovary and primary peritoneal cancer. It can also be utilized for certain psychological conditions like hallucinations and somatic disorders."
Answered by AI
What potential risks may be associated with Olaparib dosing?
"Considering the phase 2 status, there was sufficient evidence to assign Olaparib a score of two with respect to safety on our internal scale. Efficacy data has yet to be collected for this drug."
Answered by AI
What is the current size of the cohort participating in this experiment?
"Affirmative. Clinicaltrials.gov data demonstrates that this investigation, initially published on April 29th 2021, is actively enlisting patients. In total, 152 volunteers need to be enrolled from 100 distinct sites."
Answered by AI
Could you outline any additional experimentation that has been conducted with Olaparib?
"Currently, there are 188 active Olaparib trials, 27 of which are in the final phase. In particular, Houston boasts a large amount of these investigations; however, all across the US there are over 9250 clinical trial sites researching this medication."
Answered by AI
Does this clinical trial represent a new approach to treatment?
"Olaparib has been the focus of research since 2005, when a clinical trial sponsored by AstraZeneca concluded with 98 participants. Subsequently, Phase 1 drug approval was granted; and presently, there are 188 active trials for Olaparib in 1468 separate cities across 59 countries."
Answered by AI
Is this medical experiment actively seeking participants at present?
"Affirmative, the information hosted on clinicaltrials.gov indicates that this research is currently recruiting participants. Originally posted April 29th 2021 and edited November 23rd 2022, it seeks 152 patients from 100 distinct sites."
Answered by AI
How many facilities are running this research initiative?
"The Saint Luke's Cancer Institute - Fruitland in Fruitland, Idaho, Carle Physician Group-Effingham in Effingham, Illinois and Gundersen Lutheran Medical Center in La Crosse Wisconsin are the three primary sites for this trial. Additionally, there are a hundred additional medical centres participating."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger