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

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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.

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
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
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)
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
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
check
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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Verified sites

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

Verified
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Verified
Azienda Unita Sanitaria Locale Della Romagna
Faenza, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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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.

Saruparib

What is already known about the treatment

Since no specific medication names are provided in the source data, I cannot create medication descriptions in the requested format. The data shows only that this is a master protocol study investigating unspecified "novel anticancer agent(s)" for advanced/recurrent ovarian cancer, with a primary focus on safety and tolerability. Without specific medication names, I cannot provide detailed descriptions about forms of administration, mechanisms of action, or pharmacological classifications. If you would like medication descriptions, please provide the specific names of the medications being tested in this clinical trial.

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.