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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hospital Clinico Universitario De Valencia Valencia Spain
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Hwjhfrrnb Mbrfsqgk Sxljaa Milan Italy
Iszulnmbt Oadlauufdu Dyh Rwtiuk Srhn Barcelona Spain
Hudsdoyf Vhmv dayouquq Barcelona Spain

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

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
10.10.2025
Spain Spain
Not recruiting
10.10.2025

Trial locations

Investigated drugs:

Based on the provided trial data, I cannot identify specific medications or therapies to list, as the source information only contains general information about a master protocol study for novel anticancer agents in ovarian cancer treatment. The trial appears to be a Phase I/II study framework that may test various anticancer treatments, but specific medications are not mentioned in the provided data.

If you’d like me to list and describe specific medications, please provide additional trial data that includes the actual therapeutic agents being studied.

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 ID:
2024-519044-32-00
Protocol code:
D9724C00001
Trial Phase:
Human Pharmacology (Phase I) – Other

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