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A Study of Olaparib Maintenance Treatment for Patients with Metastatic Pancreatic Cancer That Responded to First-Line Chemotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with metastatic pancreatic adenocarcinoma, which is a type of cancer that started in the pancreas and has spread to other parts of the body. The treatment being studied is Lynparza, which contains the active substance olaparib (also known by its code name AZD-2281). This medication is given as film-coated tablets that are taken by mouth. The study focuses on patients whose cancer has not gotten worse after receiving at least 16 weeks of combination chemotherapy as their first treatment for the spread of cancer.

The purpose of this study is to evaluate how well olaparib works in patients with metastatic pancreatic cancer that has responded to or remained stable with chemotherapy. The study will look at different groups of patients: those who have certain genetic changes in genes related to DNA repair (such as BRCA1, BRCA2, or other genes involved in a process called homologous recombination) and those who do not have these changes or whose genetic status is unknown. Patients will receive olaparib as a maintenance treatment, meaning it is given to help keep the cancer under control after the initial chemotherapy has been completed. The study will track how long patients survive, how long the cancer remains controlled without getting worse, and whether the cancer shrinks or disappears.

During the study, patients will take olaparib tablets for up to 36 months. Regular check-ups will include imaging scans using CT or MRI to monitor the cancer, blood tests to check organ function and blood cell counts, and assessments of side effects. Quality of life will also be measured using questionnaires that ask about symptoms like pain, tiredness, nausea, weight loss, and overall wellbeing. The study will also collect tissue samples and genetic information to better understand which patients might benefit most from this treatment and to explore connections between specific genetic changes and how well the treatment works.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Starting treatment with olaparib
After completing at least 16 weeks of initial chemotherapy treatment, your condition will be assessed to confirm that the disease has not progressed. This assessment must be performed through at least two imaging tests conducted at least 4 weeks apart.
Before starting treatment with olaparib, blood tests and other laboratory examinations will be performed within 28 days to ensure that your organ function and blood counts are within acceptable ranges.
Your performance status will be evaluated to confirm that you are able to carry out daily activities with minimal or no limitations.
If you had elevated CA19.9 levels (a protein marker in the blood) at the start of your first chemotherapy, two measurements will be taken at least two weeks apart to confirm that these levels have not increased by more than 25 percent from their lowest point.
Treatment with olaparib must begin no more than 8 weeks after your last dose of chemotherapy. All previous chemotherapy treatment will be discontinued before starting this medication.
Step 2
Taking olaparib tablets
You will receive olaparib in the form of film-coated tablets that are taken by mouth.
The medication is available in two strengths: 100 mg tablets and 150 mg tablets.
The specific dosage, frequency, and duration of treatment will be determined based on your individual situation and how you respond to the medication.
You should take the tablets as instructed and continue the treatment as directed.
Step 3
Regular monitoring during treatment
During treatment, you will undergo regular imaging tests using CT scans (or MRI scans if CT is not suitable for you) to monitor the disease.
These imaging assessments will follow modified RECIST 1.1 criteria, which are standardized guidelines used to evaluate whether the disease is responding to treatment, remaining stable, or progressing.
Blood tests will be performed regularly to monitor your organ function and blood counts throughout the treatment period.
Any side effects or adverse events will be monitored and recorded according to standard safety criteria.
Step 4
Quality of life assessments
You will be asked to complete questionnaires at various times during the treatment to assess your quality of life.
These questionnaires will evaluate your overall well-being and specific symptoms such as pain, fatigue, nausea, weight loss, loss of appetite, and jaundice (yellowing of the skin or eyes).
The information collected will help assess how the treatment affects your daily life and symptoms.
Step 5
Ongoing treatment and follow-up
You will continue taking olaparib as a maintenance treatment for as long as the disease remains controlled and you do not experience unacceptable side effects.
Your doctor will monitor the time to disease progression and overall response to the medication through regular assessments.
If the disease progresses while on olaparib, the time to this progression will be recorded, and further treatment options will be discussed.
Follow-up will continue to track your survival and disease status at specific time points, including 12 months and 24 weeks from the start of olaparib treatment.
Step 6
Contraception requirements during and after treatment
If you are a woman of childbearing potential, you must use a highly effective method of birth control during the treatment period.
You should continue using this method for a minimum of 6 months after the last dose of olaparib.
If you have a male partner who has not been sterilized, he must use a male condom plus spermicide during this period.
Women who are one year past menopause, surgically sterile, or using highly effective contraception (with a failure rate of less than 1 percent per year) are eligible for the treatment.

Who can join the trial?

17 criteria

You must be able to understand and sign the informed consent form, which is a document explaining the study and your rights as a participant
You must have metastatic PDAC, which is pancreatic cancer that has spread to other parts of the body
You must have received at least 16 weeks of first-line chemotherapy, which is the first treatment given for your cancer using drugs that kill cancer cells, and your disease must be controlled (not getting worse)
Your cancer must not be growing, which will be confirmed by at least two imaging scans (pictures of the inside of your body) done at least 4 weeks apart
If you had high levels of a substance called CA19.9 in your blood at the start of chemotherapy, this level must not have increased by more than 25% from its lowest point, checked in two blood tests done at least two weeks apart
You may have changes in certain genes called BRCA or HR-related genes, which are checked through genetic testing. You can join the study whether or not you have these gene changes
If you are a woman who can become pregnant, you must be using a highly reliable method of birth control that prevents pregnancy in more than 99 out of 100 women, or you must be past menopause (no periods for at least 1 year) or surgically unable to have children
Women who can become pregnant must continue using birth control for at least 6 months after the last dose of study treatment
Male partners of women who can become pregnant must use a condom plus spermicide
Your blood tests must show adequate levels: hemoglobin (protein that carries oxygen in blood) at least 10.0 g/dL without recent blood transfusions, white blood cells (cells that fight infection) at least 1.5 x 10^9/L, and platelets (cells that help blood clot) at least 100 x 10^9/L
Your liver function tests must be within acceptable limits: bilirubin (substance from broken down red blood cells) no more than 1.5 times the normal upper limit, and liver enzymes called AST and ALT no more than 2.5 times normal, or 5 times normal if cancer has spread to your liver
Your kidney function must be adequate, with a creatinine clearance (measure of how well kidneys filter waste) of at least 51 mL/min
Your performance status must be 0 or 1 on the ECOG scale, which means you are able to carry out normal activities or have some symptoms but can do light work
Your doctors must expect that you will live at least 16 weeks
You must be at least 18 years old
Your cancer must be confirmed by examining tissue or cells under a microscope
You must agree to provide samples for biomarker research, which involves studying substances in your body that may help understand how the treatment works

Who cannot join the trial?

4 criteria

You cannot join if your cancer has gotten worse or grown during your first chemotherapy (cancer treatment using medicines that kill cancer cells)
You cannot join if you received less than 16 weeks of your first chemotherapy treatment
You cannot join if you did not receive treatment with multiple chemotherapy medicines together as your first treatment
You cannot join if you have not been diagnosed with metastatic PDAC (pancreatic cancer that has spread to other parts of the body)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Centro Ricerche Cliniche Di Verona S.r.l.
Verona, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
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Ospedale San Raffaele S.r.l.
Milan, Italy

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Investigated drugs

Olaparib is a cancer medication that works by blocking certain proteins in cancer cells that help them repair their DNA. When these proteins are blocked, the cancer cells cannot fix their damaged DNA and eventually die. In this trial, olaparib is being tested as a maintenance treatment for patients with metastatic pancreatic cancer who have responded well to chemotherapy. The goal is to help keep the cancer under control for a longer period of time after chemotherapy has been completed.

Olaparib

What is already known about the treatment

Olaparib – Olaparib is an oral medication taken in tablet form that is used to maintain cancer control in patients whose tumors have responded to initial chemotherapy treatment. This drug is approved for use in various cancers and is being studied in metastatic pancreatic cancer patients who have not worsened after receiving combination chemotherapy for at least 16 weeks. It works by blocking a protein called PARP, which normally helps cancer cells repair their damaged DNA, causing these cells to die when they cannot fix their genetic material. Olaparib belongs to a class of medications called PARP inhibitors, which are targeted cancer therapies that interfere with specific molecules involved in tumor growth.

Investigated diseases

Metastatic Pancreatic Ductal Adenocarcinoma – Metastatic pancreatic ductal adenocarcinoma is a type of cancer that originates in the cells lining the ducts of the pancreas and has spread to other parts of the body. The pancreas is an organ located behind the stomach that helps with digestion and blood sugar control. This disease begins when abnormal cells in the pancreatic ducts grow uncontrollably and form a tumor. As the cancer progresses, these cells break away from the original tumor and travel through the bloodstream or lymphatic system to distant organs. The spread of cancer cells to other body parts is called metastasis, which represents an advanced stage of the disease. Common sites where this cancer spreads include the liver, lungs, and abdominal cavity.