Study of alpelisib and olaparib combination compared to chemotherapy in patients with platinum-resistant high-grade serous ovarian cancer without BRCA mutation

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What is this study about?

This study focuses on high-grade serous ovarian cancer that is resistant to platinum-based therapy and has no germline BRCA mutation. The research examines a combination treatment using two medications: alpelisib and olaparib, comparing it to standard chemotherapy treatment. The chemotherapy options in the study include doxorubicin and paclitaxel, which are commonly used cancer medications given through an intravenous infusion.

The main purpose is to determine if the combination of alpelisib and olaparib is more effective at slowing down cancer progression compared to using a single chemotherapy medication. Alpelisib and olaparib are taken as tablets by mouth, while the chemotherapy medications are given through an infusion into a vein.

During the study, participants will be randomly assigned to receive either the combination of alpelisib and olaparib tablets or chemotherapy infusions. The study will monitor how the cancer responds to treatment and track any side effects that may occur. Participants will have regular check-ups to assess their overall health and how well they are tolerating the treatment.

1 Initial assessment

Your eligibility for the study will be evaluated based on your medical history of high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer

A test will confirm that you do not have a BRCA1/2 gene mutation

Your physical condition will be assessed using the ECOG performance scale (a measure of daily living abilities)

2 Treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: Combination of alpelisib and olaparib (both taken by mouth)

Group 2: Standard chemotherapy with either doxorubicin or paclitaxel (given through intravenous infusion)

3 Treatment period

Your treatment will continue until your disease progresses or you experience unacceptable side effects

Regular assessments will monitor your tumor response using imaging scans

Blood tests will measure your CA-125 levels (a tumor marker)

Your physical condition and any side effects will be monitored throughout the treatment

4 Follow-up assessments

Regular evaluations will track your overall health status

Quality of life assessments using the FACT-O questionnaire (a survey about your physical and emotional well-being)

Monitoring of any side effects will continue

The study is expected to continue until January 2026

Who Can Join the Study?

You must be a female aged 18 or older
You must have a confirmed diagnosis of high-grade serous or high-grade endometrioid cancer in one of these areas:
– Ovaries
– Fallopian tubes
– Primary peritoneal area (the lining of the abdominal cavity)
You must have measurable disease that can be tracked either through:
– Visible tumors that can be measured through imaging (RECIST criteria), or
– Blood tests measuring CA-125 levels (a protein marker for ovarian cancer)
You must not have an inherited (germline) mutation in BRCA1/2 genes as confirmed by approved testing
You must be relatively active and able to care for yourself (ECOG performance status of 0 or 1)
Your cancer must be either:
– Platinum-resistant (cancer returned within 1-6 months after platinum chemotherapy), or
– Platinum-refractory (cancer grew during platinum treatment or within 4 weeks after)
You must have received at least 1 but no more than 3 previous cancer treatments
You must have either:
– Previously received bevacizumab treatment, or
– Have medical reasons that make you unable to receive bevacizumab

Who Cannot Join the Study?

Presence of germline BRCA mutation (inherited genetic changes in BRCA genes)
Male patients (study is only open to female participants)
Age below 18 years (must be adult)
Previous treatment with alpelisib or olaparib (the study medications)
Any type of ovarian cancer other than high-grade serous ovarian cancer
Active brain metastases (cancer spread to the brain)
Severe heart conditions or uncontrolled high blood pressure
Significant liver or kidney dysfunction
Known allergy or sensitivity to the study medications
Pregnancy or breastfeeding
Participation in another clinical trial within 30 days before starting this study
Any condition that would make it unsafe to participate in the trial, as determined by the study doctor
Unable to follow study procedures or attend required visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kuopio University Hospital	Kuopio	Finland
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country	Status
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Turku University Hospital	Turku	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	08.09.2021
Germany	Not recruiting	08.09.2021
Spain	Not recruiting	08.09.2021

Trial locations

Investigated drugs:

Alpelisib is a medication that targets specific proteins involved in cancer cell growth. It works by blocking a pathway that cancer cells often use to multiply and survive. This medication is taken orally and is used in the treatment of certain types of cancer.

Olaparib is a targeted therapy medication that works by blocking an enzyme that cancer cells need to repair their damaged DNA. By preventing this repair process, it can help stop cancer cells from growing and surviving. This medication is commonly used in the treatment of ovarian cancer.

Cytotoxic chemotherapy refers to traditional cancer treatments that work by directly killing cancer cells or stopping them from dividing. These medications target rapidly dividing cells throughout the body. While effective against cancer cells, they can also affect healthy cells that divide quickly.

High-grade serous ovarian cancer – A form of ovarian cancer that develops in the cells lining the ovaries or fallopian tubes. It is characterized by the rapid growth of abnormal cells that can spread throughout the pelvis and abdomen. The disease typically develops in the outer cells of the ovary or fallopian tubes. This type of cancer tends to grow and divide quickly compared to other forms of ovarian cancer. The cells in this cancer appear very abnormal when viewed under a microscope, which is why it’s classified as “high-grade.”

Platinum-resistant ovarian cancer – A specific condition where ovarian cancer continues to grow or returns within 6 months after completing platinum-based chemotherapy. This represents a form of the disease that has developed resistance to standard platinum-based treatments. The cancer cells have evolved mechanisms to survive despite exposure to platinum-based drugs.

Trial ID:

2024-510782-42-00

Protocol code:

CBYL719K12301

NCT ID:

NCT04729387

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of alpelisib and olaparib combination compared to chemotherapy in patients with platinum-resistant high-grade serous ovarian cancer without BRCA mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?