Active not recruitingPHASE3INTERVENTIONAL

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

This study is investigating a drug called Olaparib for women with advanced ovarian cancer that has a BRCA gene mutation. These women will have recently finished their first course of chemotherapy. The study wants to see if taking Olaparib daily as a maintenance therapy (meaning it's given after initial treatment to prevent the cancer from coming back) can help keep the cancer under control for longer compared to a dummy pill (placebo). It's a large-scale study involving many centres, and half the participants will receive Olaparib, while the other half will receive a placebo, but neither the patient nor their doctor will know who is getting what until later. This helps ensure fair results and helps us understand if Olaparib is an effective treatment in this situation.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

450

Start

26 Aug 2013

Estimated completion

29 Aug 2028

Newly Diagnosed Advanced Ovarian Cancer FIGO Stage III-IV BRCA Mutation Complete Response Partial Response First Line Platinum Chemotherapy

Results

Results from this study

Posted July 2019

Results have been published for this study.

Primary outcome

Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.

Full results on the registry

What is this study about?

This study is all about helping women who have been diagnosed with an advanced type of ovarian cancer. Specifically, it focuses on those whose cancer has a particular genetic fault, called a BRCA mutation. You might have heard of BRCA mutations because they can increase the risk of certain cancers, including ovarian cancer.

After initially being diagnosed, patients usually receive chemotherapy. This study is for women who have responded well to this first round of chemotherapy, meaning the treatment has shrunk their cancer or made it disappear. The researchers want to find out if taking a drug called Olaparib after chemotherapy can help prevent the cancer from coming back or growing again for a longer period. Olaparib is given as a daily tablet.

To make sure the results are reliable, half of the women in the study will receive Olaparib, and the other half will receive a placebo (a tablet with no active drug). Neither the patients nor their doctors will know who is getting which tablet until the study is over. This is a common and important way to test new medicines fairly. The aim is to see if Olaparib can offer a benefit in keeping the cancer under control after initial treatment.

Key takeaways

This study is for women with advanced ovarian cancer and a BRCA mutation.
It tests if a drug called Olaparib can keep cancer away after initial chemotherapy.
Half of participants receive Olaparib, half receive a dummy pill (placebo).
Participation involves taking daily tablets and regular check-ups.
The study aims to improve long-term outcomes for women with this specific cancer type.

Who may be eligible?

This study is specifically designed for women who have been recently diagnosed with advanced ovarian cancer (or similar cancers like primary peritoneal or fallopian tube cancer) where the cancer has a specific BRCA gene mutation.

To be considered, you must have completed your first course of chemotherapy and the treatment must have been successful in shrinking your cancer or making it disappear. There should be no signs that the cancer is growing again after your chemotherapy. Also, any surgery you had for your cancer should generally have been a single operation, with no more than one debulking procedure.

There are also some things that would mean you couldn't take part. For example, if your BRCA mutation isn't thought to be harmful, or if your cancer was diagnosed at a very early stage. You also wouldn't be eligible if your cancer showed signs of growing again after your first chemotherapy treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman who has recently been diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer?
Does your cancer have a known BRCA gene mutation?
Have you recently finished your first course of chemotherapy, and did your cancer respond well (shrink or disappear)?
Are you able to start the study treatment within 8 weeks of your last chemotherapy dose?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive 300mg tablets of either Olaparib or a placebo twice a day. You would have regular check-ups, scans, and blood tests to monitor your health and the cancer's status. The exact number of visits and tests would be explained to you in detail. The total duration of participation on the treatment would vary, but follow-up would continue for a longer period to see how you are doing in the long term. You would need to start the study drug within 8 weeks of your last dose of chemotherapy.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of a new treatment that might help keep your ovarian cancer under control for longer. However, like all medications, Olaparib can have side effects, and these would be fully explained to you before you agree to participate. You will be closely monitored for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (177)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Clearview Cancer Institute
Verified postcode
Huntsville, United States
Providence Cancer Center
Verified postcode
Anchorage, United States
St. Joseph's Hospital & Medical Center
Verified postcode
Phoenix, United States
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States
University of California, Los Angeles
Verified postcode
Los Angeles, United States
Kaiser Permanente
Verified postcode
Oakland, United States
Kaiser Permanente
Verified postcode
Roseville, United States
Stanford Women's Cancer Center
Verified postcode
Stanford, United States
Babak Edraki
Verified postcode
Walnut Creek, United States
University of Colorado
Verified postcode
Aurora, United States
Univ of Connecticut Health Center
Verified postcode
Farmington, United States
Smilow Cancer Hospital at Yale New Haven
Verified postcode
New Haven, United States

Common questions

What is a BRCA mutation?

A BRCA mutation is a change in specific genes (BRCA1 or BRCA2) that can increase a person's risk of developing certain cancers, including ovarian cancer. This study is for women whose ovarian cancer has this particular genetic change.

What is 'maintenance monotherapy'?

Maintenance monotherapy means taking a single drug (monotherapy) after initial treatment (chemotherapy in this case) to help prevent the cancer from coming back or to keep it under control for a longer time.

What is a placebo?

A placebo is an inactive tablet that looks exactly like the study drug but contains no active medicine. It's used in studies to compare against the active drug to see if the drug really makes a difference.

Will I know if I'm getting Olaparib or the placebo?

No, neither you nor your doctor will know whether you are receiving Olaparib or the placebo during the study. This is called 'double-blind' and helps ensure the study results are fair and unbiased.

Can I stop participating in the study if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your standard medical care or your relationship with your doctors.