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PARP Inhibitor
Olaparib for Pancreatic Cancer
Phase 2
Recruiting
Led By Christine C Alewine, M.D.
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
Age >=18 years.
- Creatinine clearance must be >51 mL/min as estimated using the Cockroft-Gault equation* or measured by 24- hour urine test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-last dose of olaparib
Awards & highlights
Study Summary
This trial is studying olaparib as a possible treatment for pancreatic acinar cell carcinoma.
Who is the study for?
Adults with advanced Pancreatic Acinar Cell Carcinoma (PACC) who have tried other treatments without success or can't undergo surgery. They must be at least 18, not pregnant, and agree to use contraception. Participants need measurable disease per specific criteria, adequate organ function, and no recent major surgeries or investigational therapies.Check my eligibility
What is being tested?
The trial is testing the effectiveness of olaparib for PACC in adults. Olaparib will be taken orally twice daily in cycles of 21 days for up to two years unless side effects become severe or cancer worsens. The study includes regular check-ups, blood tests, CT scans every eight weeks starting from cycle two, and optional tumor biopsies.See study design
What are the potential side effects?
Olaparib may cause fatigue, nausea, vomiting, diarrhea or constipation; anemia; low white blood cell counts increasing infection risk; changes in taste; loss of appetite; dizziness; headache; coughing or shortness of breath.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My kidney function, measured by creatinine clearance, is good.
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My hemoglobin level is at least 10 g/dL without recent blood transfusions.
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It has been over 3 weeks since my last chemotherapy or radiation therapy.
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My pancreatic cancer diagnosis has been confirmed by NIH pathology.
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It's been over 5 weeks since I last used specific strong medications.
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I have had one chemotherapy treatment or cannot have it, and my tumor cannot be surgically removed.
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I am fully active and can carry on all my pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-last dose of olaparib
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-last dose of olaparib
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
antitumor activity
Secondary outcome measures
anti-tumor efficacy
safety
Side 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: Arm 1Experimental Treatment1 Intervention
Olaparib, taken orally, twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,692 Previous Clinical Trials
40,929,955 Total Patients Enrolled
Christine C Alewine, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
114 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong or moderate CYP3A inhibitors in the last 2 weeks.I have no severe side effects from past cancer treatments.I have recovered from recent surgeries and it's been over 2 weeks since any minor procedure.My kidneys are functioning well enough, based on a calculation involving my age, weight, and gender.I have been diagnosed with superior vena cava syndrome.I am 18 years old or older.I have symptoms of heart failure.My spinal cord compression is stable for 28 days after treatment.I agree to use birth control during the study because the medication may harm an unborn baby.I agree not to drink grapefruit juice during the study.I have unstable chest pain.I have had a bone marrow or cord blood transplant in the past.My kidney function, measured by creatinine clearance, is good.I have brain metastases that are not well-controlled without increasing medication.I have no cancer other than PACC, or any I had was cured over 5 years ago, except for certain skin, cervical, breast, or endometrial cancers.I do not have any serious uncontrolled illnesses besides cancer.My hemoglobin level is at least 10 g/dL without recent blood transfusions.I had a heart attack in the last 3 months.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I can provide my past medical records.It has been over 3 weeks since my last chemotherapy or radiation therapy.My organ and bone marrow functions are within normal ranges.My lung scan shows widespread scarring or inflammation.You have had allergic reactions to drugs that are similar to olaparib.I cannot take pills by mouth or have a stomach condition that affects medication absorption.I am breastfeeding and do not want to stop.I have a lot of fluid in my abdomen, low blood protein, or had fluid removed recently.My pancreatic cancer diagnosis has been confirmed by NIH pathology.It's been over 5 weeks since I last used specific strong medications.I have had one chemotherapy treatment or cannot have it, and my tumor cannot be surgically removed.I am fully active and can carry on all my pre-disease activities without restriction.I have frequent and uncontrolled seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
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.
How many subjects are involved in this experiment?
"Affirmative. According to clinicaltrials.gov, the trial that was initially posted on December 6th 2022 is still looking for participants and has been edited as recently as November 30th 2022. 20 people need to be recruited at a single site."
Answered by AI
Has the FDA given its stamp of approval to Olaparib?
"Olaparib's safety is rated a 2 on the scale due to only preliminary data being available that suggests its security; there has yet to be any evidence indicating efficacy."
Answered by AI
Are there any openings to participate in this experiment as a subject?
"The information located on clinicaltrials.gov suggests that this medical trial is currently enrolling volunteers; the first listing of which was posted December 6th 2022, with a subsequent update made at the end of November 2022."
Answered by AI
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