Active not recruitingPHASE2INTERVENTIONAL

Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

This research study is for women with advanced ovarian cancer. It aims to find out if adding a drug called olaparib to the usual chemotherapy treatment (carboplatin and paclitaxel) is more effective and just as safe as receiving only chemotherapy. Researchers want to compare these two approaches to see if combining olaparib could lead to better outcomes for patients. This is a Phase 2 study, which means it builds on earlier research and looks at how well the new combination works and its safety in a larger group of people. The ultimate goal is to improve treatments for ovarian cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

162

Start

04 Feb 2010

Estimated completion

31 Dec 2026

Ovarian Cancer

What is this study about?

This study is for women who have advanced ovarian cancer. Doctors are always looking for better ways to treat this condition, and this study focuses on a new approach. We know that standard chemotherapy, which often includes drugs like carboplatin and paclitaxel, can help. This study wants to see if adding another drug, called olaparib, to this standard chemotherapy might make the treatment even more effective.

Olaparib is a type of drug that works differently from traditional chemotherapy. It targets specific weaknesses in cancer cells, which could potentially boost the effect of the chemotherapy. By combining these treatments, the researchers hope to find a way to more effectively fight the cancer. The study will carefully compare the results of patients who receive the combination treatment with those who only receive the standard chemotherapy.

The main goal is to understand if this new combination improves how well the treatment works and if it's still safe for patients. Finding more effective and safer treatments is really important for improving the lives of women with ovarian cancer.

Key takeaways

This study is testing a new combination of drugs for advanced ovarian cancer.
It compares olaparib plus chemotherapy to chemotherapy alone.
The aim is to find more effective and safer treatments.
Eligibility includes specific ovarian cancer type and prior treatment history.
Regular hospital visits, tests, and scans are part of participation.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, you would need to have been diagnosed with a specific type of ovarian cancer called serous ovarian cancer. You must also have received some platinum-based chemotherapy treatments before, but no more than three. Importantly, your cancer must not have grown for at least six months after your last platinum-based treatment. The doctors will also need to be able to measure at least one area of your cancer very accurately over time to see how it responds to treatment.

There are also some reasons why you wouldn't be able to join. For example, if you've had other cancer treatments like chemotherapy or radiotherapy (excluding pain relief radiotherapy) in the two weeks leading up to the study, you wouldn't be eligible. Also, if you have a known allergy or severe reaction to any of the medicines that would be used in the study, such as paclitaxel or carboplatin, you wouldn't be able to take part. The study is open to adult women, generally aged 18 and over.

Quick self-check

Have you been diagnosed with serous ovarian cancer?
Have you had no more than three previous platinum-based chemotherapy treatments?
Has it been at least 6 months since your last platinum-based treatment and your cancer has not grown?
Do you have a measurable area of cancer that doctors can track?
Have you avoided other cancer treatments (like chemo or radiotherapy, except for pain relief) in the last two weeks?
Are you able to take the study medications without a known severe allergy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular hospital visits. During these visits, you would receive your study medication (either the combination of olaparib, carboplatin, and paclitaxel, or carboplatin and paclitaxel alone). You would also have regular check-ups, which include physical examinations, blood tests, and scans (like CT or MRI scans) to see how the treatment is working and to monitor any side effects. The doctors will closely watch your health throughout the study. The total duration of the study treatment period would depend on how your body responds to the medication, but typically, patients continue treatment as long as it is working and side effects are manageable. After the main treatment, there might be a follow-up period where your health is still monitored.

Potential risks and benefits

Potential benefits of joining this study include receiving a new treatment combination that might be more effective than standard chemotherapy alone for your ovarian cancer. While there's no guarantee the treatment will work for everyone, you will be closely monitored by medical professionals. However, there are also potential risks, as all medications can have side effects. Olaparib, carboplatin, and paclitaxel can cause side effects like tiredness, nausea, hair loss, and changes in blood counts. The study team will explain all known side effects in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (53)

Research Site
Stanford, United States
Research Site
West Hollywood, United States
Research Site
Orlando, United States
Research Site
Indianapolis, United States
Research Site
Boston, United States
Research Site
Boston, United States
Research Site
New York, United States
Research Site
Portland, United States
Research Site
Parkville, Australia
Research Site
Randwick, Australia
Research Site
Brussels, Belgium
Research Site
Leuven, Belgium

+41 more sites — see the official record for the full list.

Common questions

What is olaparib?

Olaparib is a medication that works by targeting specific weaknesses in cancer cells to help stop them from growing.

Is this a new treatment?

The use of olaparib with this specific chemotherapy combination is being studied here to see how well it works together.

Will I know which treatment I'm getting?

In this type of study, participants are usually randomly assigned to one of the treatment groups, and sometimes neither you nor your doctor will know which treatment you are getting. The study team will explain this to you.

How long will the treatment last?

The treatment would continue for as long as it is helping you and any side effects are manageable, according to the study doctors.

Can I stop taking part if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect your future medical care.