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Study of Saruparib in Patients with Advanced or Recurrent Ovarian Cancer to Assess Safety and Effectiveness

Verified siteFast replyInvestigationalNo placebo
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What is this trial about?

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

This clinical trial focuses on advanced ovarian cancer or recurrent ovarian cancer, including cancers of the fallopian tubes and peritoneum. The study will test a new medication called saruparib (also known as AZD5305), which comes in tablet form and is taken by mouth. The medicine will be studied both as a single treatment and in combination with other cancer medications.

The main goal of this research is to determine if saruparib is safe to use and to understand how well it works in treating advanced ovarian cancer. The study will look at how patients' bodies respond to the medication and what side effects may occur. During the study, patients will receive regular medical check-ups, including blood tests and imaging scans to monitor their health and how the cancer responds to treatment.

This is a master protocol study, which means it consists of several smaller studies testing different aspects of the treatment. Throughout the study, doctors will monitor various health indicators and collect information about how the medication affects the cancer. They will also measure the amount of medication in the blood and track changes in a substance called CA125, which can indicate how well the treatment is working.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening

    Your eligibility for the study will be evaluated through medical tests and examinations

    You will need to provide a tumor sample for biomarker testing

    Your cancer will be measured using CT or MRI scan to confirm that you have measurable disease

  2. Step 2

    Medical evaluation

    Your overall health status will be assessed using the ECOG performance scale (a measure of daily living abilities)

    Laboratory tests will check your organ and bone marrow function

    Physical examination and vital signs will be recorded

  3. Step 3

    Treatment phase

    You will receive saruparib tablets to take by mouth

    Regular assessments will monitor how your body responds to the treatment

    Blood samples will be collected to measure the levels of saruparib in your system

    Your cancer response will be evaluated through scans and CA125 blood tests (a tumor marker test)

  4. Step 4

    Ongoing monitoring

    Regular physical examinations will be performed

    Your vital signs will be checked at each visit

    Blood tests will continue to monitor your organ function

    ECG tests (heart rhythm recordings) will be performed periodically

    Any side effects or health changes will be recorded and monitored

  5. Step 5

    Treatment completion

    Final medical evaluations will be performed

    Your overall response to the treatment will be assessed

    Follow-up visits may be scheduled as determined by your healthcare team

Who can join the trial?

12 criteria

  • Must be a woman assigned female at birth
  • Must be of legal age to consent to participate in the study
  • Must be able to provide informed consent and follow study requirements
  • Must have confirmed advanced or recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (cancer that starts in the tissue lining the abdomen)
  • Must be able to provide a tumor sample for testing
  • Must have at least one measurable tumor that is:
    • At least 10 millimeters in size (or 15 millimeters for lymph nodes)
    • Can be measured by CT scan or MRI (medical imaging tests)
    • Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities with minimal assistance)
    • Must have adequate organ and bone marrow function
    • Must use appropriate contraception methods according to local guidelines
    • Must not be breastfeeding
    • Must not donate or collect eggs during the study period and for a specified time after the last treatment

Who cannot join the trial?

15 criteria

  • History of other cancer within the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Pregnant or breastfeeding women
  • Active autoimmune disease requiring systemic treatment (a condition where the immune system attacks healthy cells in the body)
  • Uncontrolled cardiovascular disease (heart and blood vessel problems)
  • Known active hepatitis B or C infection (liver infections)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Previous severe allergic reactions to similar treatments
  • Major surgery within 4 weeks before starting the study
  • Current participation in another clinical trial
  • Inability to swallow oral medications
  • Significant mental illness or condition that would interfere with the study requirements
  • Life expectancy less than 3 months
  • Uncontrolled high blood pressure
  • Immunodeficiency conditions (weakened immune system)
  • Regular use of medications that could interfere with the study treatment
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Investigated drugs

Saruparib is an experimental oral tablet being studied as a single treatment or together with other medicines for advanced or recurrent ovarian cancer. In this trial, participants take the tablet by mouth, and researchers are mainly looking at how safe it is and how well patients can tolerate it. The study uses special tests to match the drug to certain cancer markers, aiming to see if the medication works better for people whose tumors have those markers.

What is already known about the treatment

Saruparib - This medication is taken by mouth as a tablet and is being studied in clinical trials for safety and how well it is tolerated. It is not yet approved for general medical use and currently exists only in research reports and early‑stage trial data. The drug is being tested mainly for treating advanced or recurrent ovarian cancer. It works by attaching to a specific protein on cancer cells, which blocks signals that help the tumor grow and spread, placing it in the class of targeted anticancer agents.

Investigated diseases

Ovarian Cancer - A condition that develops in the ovaries, which are part of the female reproductive system. The disease begins when abnormal cells in the ovaries start to multiply uncontrollably and form tumors. Advanced ovarian cancer means the cancer has spread beyond the ovaries to other parts of the body, while recurrent means the cancer has returned after a period of remission. The disease can affect one or both ovaries and may spread to nearby pelvic organs. Common changes in the body include swelling in the abdomen, changes in bowel habits, and feeling full quickly when eating.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519044-32-00Protocol codeD9724C00001Estimated enrolment30 patientsSponsorAstraZeneca AB

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