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A Study of Saruparib for Patients with Metastatic Pancreatic Cancer with Homologous Repair Deficiency as First Treatment

Verified siteInvestigationalNo placebo

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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 pancreatic cancer that has spread to other parts of the body and cannot be cured with surgery or radiation therapy. The cancer has a specific characteristic where certain genes that help repair damage in cells are not working properly. These genes include BRCA1, BRCA2, or PALB2, and when they are altered or not functioning, the cancer is called homologous repair-deficient. The treatment being studied is Saruparib, also known by its code name AZD5305, which is given as a tablet by mouth. The purpose of the study is to see how well Saruparib works in patients with this type of pancreatic cancer who have not received chemotherapy for their advanced or metastatic disease.

During the study, patients will receive Saruparib tablets with a maximum daily dose of 60 milligrams. The treatment can continue for up to 24 months depending on how the disease responds and how well the treatment is tolerated. Patients will need to have tissue samples from their tumor available, either from previous biopsies or surgeries, or they may need to have a new biopsy taken. These samples are needed to confirm the genetic changes in the cancer cells. Regular assessments will be done to measure the size of the tumors and check how the cancer is responding to treatment.

The study will monitor patients for any side effects or unwanted reactions that may occur during treatment. Blood tests and other medical examinations will be performed regularly to ensure patients' organs are functioning properly and to track their overall health. Quality of life will also be assessed using questionnaires to understand how the treatment affects patients' daily activities and well-being. The study will measure how many patients respond to the treatment, how long the responses last, how long patients live without the cancer getting worse, and overall survival.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening and preparation
Before starting treatment, several tests will be performed to confirm eligibility for the trial.
A pregnancy test will be completed within 3 days before the first dose if applicable.
Blood tests will be performed within 7 days before the first dose to check organ function and blood cell counts.
Blood pressure will be measured to ensure it is below 140/90 mmHg.
A tissue sample from a previous surgery or biopsy will be provided, or a new biopsy may be performed if needed.
Imaging scans will be performed to measure the size and location of the cancer according to RECIST version 1.1 criteria, which is a standardized method for assessing tumor size.
Step 2
Beginning treatment with saruparib
Treatment will begin on Cycle 1, Day 1.
Saruparib will be taken by mouth in tablet form.
The specific dosage, frequency, and duration of each treatment cycle will be determined by the study doctor based on the trial protocol.
Treatment will continue in cycles until the cancer progresses or side effects become unacceptable.
Step 3
Assessment at week 16
After 16 weeks of treatment, imaging scans will be performed to assess how the cancer has responded to treatment.
The response will be evaluated using RECIST version 1.1 criteria to determine if the tumor has shrunk, remained stable, or grown.
This assessment is the main measure of how well the treatment is working.
Step 4
Ongoing treatment and monitoring
Treatment with saruparib will continue as long as it is providing benefit and side effects remain manageable.
Regular visits will occur throughout the treatment period for safety monitoring.
Blood tests will be performed regularly to monitor organ function and blood cell counts.
Blood pressure and vital signs will be checked at each visit.
Any side effects will be recorded and graded according to NCI CTCAE version 5.0, which is a standard system for classifying the severity of side effects.
Imaging scans will be repeated at regular intervals to monitor the cancer.
Quality of life questionnaires (EORTC QLQ-C30) will be completed at specified times to assess how the treatment affects daily life and well-being.
Step 5
Contraception requirements during treatment
If applicable, highly effective contraception must be used from the time of signing the consent form until 6 months after the last dose of saruparib.
Male participants must also use effective contraception during the same period and must not donate sperm.
Step 6
End of treatment
Treatment will end if the cancer progresses, side effects become too severe, or if discontinuation is decided for other medical reasons.
A final assessment will be performed at the end of treatment.
Step 7
Follow-up after treatment
After stopping treatment, follow-up visits will continue to monitor overall survival and long-term outcomes.
Information about disease progression and survival will be collected during this period.

Who can join the trial?

14 criteria

You must be at least 18 years old when you sign the consent form
You must have pancreatic cancer (cancer of the pancreas, an organ that helps with digestion) that has spread to other parts of your body or is advanced, and cannot be cured with surgery or radiation therapy
You must not have received chemotherapy (strong medicines used to treat cancer) for your advanced or spread cancer before. If you received a medicine called gemcitabine after surgery, at least 6 months must have passed between finishing that treatment and your cancer coming back
You must have a specific change in your genes (the instructions in your cells) that affects at least one of these genes: BRCA1, BRCA2, or PALB2. This change must be confirmed by a test on your blood or tumor tissue. If you already know you have an inherited change in BRCA or PALB2 genes, you can join without additional screening, but tumor tissue will still be collected
Your cancer must be measurable on scans according to specific medical criteria
You must be able to provide a sample of your tumor tissue from a previous surgery or biopsy, or be able to have a new biopsy taken
Your ability to carry out daily activities must be good to moderate. If your ability is more limited, it must have been stable for at least 2 weeks
Your expected survival must be more than 16 weeks
Your blood counts and organ function (how well your organs work) must be at acceptable levels based on blood tests done within 7 days before starting treatment
Your resting blood pressure must be below 140 over 90
If you are a woman who can become pregnant, you must have a negative pregnancy test within 3 days before starting treatment, and agree to use highly effective birth control from when you sign the consent form until 6 months after your last dose of the study medicine
If you are a man who can father children, you must agree to use effective birth control from when you sign the consent form until 6 months after your last dose of the study medicine, and agree not to donate sperm during this time
You must understand, sign, and date the consent form before any study procedures, and be able and willing to attend all required study visits and follow study procedures
You must have medical insurance coverage

Who cannot join the trial?

4 criteria

The study information provided does not contain specific exclusion criteria, which are the reasons why a patient cannot participate in the clinical trial
Without detailed exclusion criteria listed in the trial documents, it is not possible to identify specific conditions, treatments, or situations that would prevent participation
Typically, exclusion criteria may include things like certain other medical conditions, previous treatments, laboratory test results, or medications that would make it unsafe or inappropriate for a person to join the study
In this case, the trial documents do not provide the complete list of reasons that would prevent enrollment in this study for pancreatic cancer, which is cancer affecting the pancreas, an organ that helps with digestion and blood sugar control

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Verified sites

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

Centr Georges Francois Leclerc
Verified
Dijon, France
Centre Jean Perrin
Verified
Clermont Ferrand, France
Centre Leon Berard
Verified
Lyon, France

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Investigated drugs

Saruparib is a medication being tested in this clinical trial for patients with pancreatic cancer that has spread to other parts of the body. This medicine works by targeting cancer cells that have a specific weakness in their ability to repair damaged DNA. Saruparib is designed to take advantage of this weakness to help stop the cancer from growing. In this study, it is being given as the first treatment to patients with this particular type of pancreatic cancer.

Saruparib

What is already known about the treatment

Saruparib – Saruparib is an oral medication currently being studied in clinical trials as a potential treatment for patients with advanced pancreatic cancer that has specific genetic characteristics called homologous repair deficiency. This drug works by blocking certain proteins in cancer cells called PARP enzymes, which normally help repair damaged DNA; when these enzymes are blocked in cancer cells that already have difficulty repairing their DNA, the cancer cells accumulate too much damage and die. Saruparib belongs to a class of medications known as PARP inhibitors, which have shown promise in treating cancers with DNA repair defects. This medication is being investigated as a first-line treatment option for patients whose pancreatic cancer has spread to other parts of the body.

Investigated diseases

Pancreatic Adenocarcinoma – Pancreatic adenocarcinoma is a type of cancer that develops in the pancreas, an organ located behind the stomach that helps with digestion and blood sugar control. The disease begins when cells in the pancreas start to grow abnormally and form a tumor. As the cancer progresses, it can spread beyond the pancreas to nearby tissues and organs. In advanced stages, the cancer may spread to distant parts of the body through the bloodstream or lymphatic system, which is called metastatic disease. The tumor can interfere with the normal function of the pancreas and surrounding organs, causing various symptoms. This form of cancer often develops slowly over time before being detected.