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Study of Olaparib Treatment in Patients with Advanced Pancreatic Cancer Having PALB2 Gene Mutation

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What is this study about?

This study focuses on advanced pancreatic cancer specifically in patients who have a particular genetic change called PALB2 mutation. The study will test a medication called Lynparza (also known as olaparib), which is given as film-coated tablets taken by mouth. This research aims to determine how well this treatment works in patients whose cancer has spread or cannot be removed by surgery.

The treatment involves taking Lynparza tablets daily for up to 24 months. The medication is available in two different strengths: 100 mg and 150 mg tablets. The daily dose can range from 400 mg to 600 mg, depending on what the doctor prescribes. Patients will need regular check-ups and imaging tests to monitor how their cancer responds to the treatment.

During the study, doctors will track how the cancer responds to the treatment by looking at changes in tumor size through special imaging tests. They will also monitor how long the treatment keeps working and check for any side effects that patients might experience. The study will also look at how the treatment affects patients’ overall well-being and quality of life.

1 Initial assessment and verification

Your eligibility for the study will be confirmed through medical tests and documentation review

A CT scan or MRI will be performed to measure your tumor(s)

Basic health parameters and organ function will be checked through laboratory tests

If you are a woman who can become pregnant, a pregnancy test will be conducted

2 Treatment initiation

You will receive Lynparza tablets (olaparib) for oral use

The medication is available in two strengths: 100 mg and 150 mg film-coated tablets

The treatment will be taken daily according to the prescribed dosage

Your first dose will mark the beginning of the treatment cycle

3 Regular monitoring

At the start of each treatment cycle, you will undergo health assessments

Female patients will have pregnancy tests at the beginning of each cycle

Your tumor response will be evaluated using imaging scans (CT or MRI)

You will complete a quality of life questionnaire (EORTC QLQ-C30)

4 Safety measures

You must use effective contraception during treatment

Female patients must continue contraception for 1 month after treatment ends

Male patients must continue contraception for 3 months after treatment ends

Breastfeeding is not permitted during the study period

5 Study completion

Your participation will continue until September 2025 or earlier if specified by the study protocol

Final assessments will be conducted to evaluate your health status

Your tumor response will be measured one last time

A final quality of life assessment will be performed

Who Can Join the Study?

  • Must be over 18 years of age
  • Must have confirmed pancreatic adenocarcinoma (a type of pancreatic cancer) through tissue or cell examination
  • Must have advanced disease that cannot be surgically removed or has spread to other parts of the body
  • Must have completed genetic testing showing a specific mutation in the PALB2 gene
  • Must have received at least one previous treatment for advanced disease
  • Must have at least one tumor that can be measured using special imaging techniques (CT scan or MRI)
  • Must have a life expectancy of more than 16 weeks as determined by the doctor
  • Must have good physical function status (ECOG PS of 0 or 1, meaning able to perform daily activities)
  • Must have proper organ function before starting treatment
  • Women who can become pregnant must have a negative pregnancy test before starting and during treatment
  • Both men and women who can have children must use effective birth control during treatment and after (1 month for women, 3 months for men)
  • Women cannot breastfeed during the study
  • Must be able to read, understand, and sign the informed consent document

Who Cannot Join the Study?

  • Previous treatment with olaparib or other PARP inhibitors (drugs that block DNA repair in cancer cells)
  • History of other cancers within the past 3 years, except for adequately treated non-melanoma skin cancer or cervical cancer
  • Presence of brain metastases (cancer spread to the brain) that are not stable or require ongoing treatment
  • Severe heart conditions including:
    • Heart attack within the last 3 months
    • Uncontrolled high blood pressure
    • Unstable heart rhythm problems
  • Active hepatitis B or C infection
  • Known HIV infection
  • Any serious medical condition that could interfere with study participation
  • Pregnancy or breastfeeding
  • Unable to swallow oral medications
  • Participation in another clinical trial within the last 30 days
  • Known allergic reactions to the study medication or its components
  • Major surgery within 2 weeks before starting the study treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Degli Studi Di Verona Verona Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
19.09.2023

Trial locations

Investigated drugs:

Olaparib is an oral medication that belongs to a class of drugs called PARP inhibitors. It works by blocking an enzyme that helps repair damaged DNA in cells. This medication is particularly effective in cancers with specific genetic mutations, including those related to the PALB2 gene. In pancreatic cancer patients with PALB2 mutations, this medication may help stop cancer cells from repairing their damaged DNA, which can lead to the death of these cancer cells.

Pancreatic neoplasm – A condition where abnormal cells grow in the pancreas, forming tumors that can spread to other parts of the body. The disease specifically involves changes in the PALB2 gene, which can occur either in the tumor cells themselves or be inherited. The condition can affect how the pancreas functions, potentially impacting its ability to produce digestive enzymes and hormones. As the disease progresses, it can spread from its original location to nearby tissues or distant parts of the body. The presence of PALB2 mutations makes this form of pancreatic cancer distinct from other types.

Trial ID:
2024-516466-11-00
Trial Phase:
Therapeutic exploratory (Phase II)

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