Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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)
Step 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)
Step 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
Step 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 trial?

8 criteria

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 trial?

13 criteria

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

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Verified sites

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

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Kuopio University Hospital
Verified
Kuopio, Finland
Technische Universitaet Dresden
Verified
Dresden, Germany

Trial locations

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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.

What is already known about the treatment

Alpelisib
A targeted therapy medication taken orally that works by inhibiting PI3K (phosphatidylinositol-3-kinase), a key enzyme involved in cell growth and survival. This drug is being investigated in clinical trials for platinum-resistant ovarian cancer treatment, particularly in patients without BRCA mutations. Alpelisib belongs to the class of kinase inhibitors and works by blocking specific cellular signaling pathways that cancer cells use to grow and spread.
Olaparib
An oral medication belonging to the class of PARP (poly ADP-ribose polymerase) inhibitors, which works by preventing cancer cells from repairing their damaged DNA, leading to their death. It is approved for various types of cancer treatment, including ovarian cancer, and is being studied in combination with alpelisib for patients with platinum-resistant ovarian cancer who don't have BRCA mutations. This targeted therapy represents a more precise approach to cancer treatment compared to traditional chemotherapy.

Investigated diseases

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.