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Study of Olaparib for Patients with Advanced BRCA-Mutated Ovarian Cancer After Initial Platinum-Based Chemotherapy

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What is this study about?

This clinical trial is focused on studying BRCA mutated advanced ovarian cancer, which is a type of cancer that affects the ovaries and is linked to specific genetic changes known as BRCA mutations. The study will use a treatment called olaparib, which is taken as a tablet. Olaparib is designed to help maintain the health of patients who have already received their first round of chemotherapy, a common cancer treatment that uses drugs to kill cancer cells.

The purpose of this study is to compare the effects of olaparib with a placebo in patients with advanced ovarian cancer who have responded well to their initial chemotherapy. Participants will be randomly assigned to receive either olaparib or a placebo. The study will last for a period of up to 36 months, during which time the health of the participants will be closely monitored. This includes regular check-ups and assessments to see how the cancer is responding to the treatment.

Throughout the study, the main focus will be on how long patients remain free from cancer progression, which means the cancer does not get worse. This is known as progression-free survival. The study will also look at other important factors, such as overall survival and any side effects that may occur. The information gathered from this study will help determine the effectiveness of olaparib as a maintenance therapy for patients with BRCA mutated advanced ovarian cancer.

1 joining the study

Upon joining the study, eligibility is confirmed. This includes having a BRCA mutation and having completed first-line platinum-based chemotherapy for advanced ovarian cancer.

The study is designed for patients who have shown a complete or partial response to initial treatment.

2 randomization

Participants are randomly assigned to receive either olaparib or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 treatment administration

The treatment involves taking olaparib or a placebo orally. The medication is available in two dosages: 150 mg and 100 mg film-coated tablets.

The specific dosage and frequency of administration are determined by the study protocol and are followed throughout the trial.

4 monitoring and assessments

Regular assessments are conducted to monitor the progression of the disease. This includes physical examinations, vital signs checks, and laboratory tests.

The primary focus is on progression-free survival, which is evaluated using specific criteria to determine the effectiveness of the treatment.

5 completion of the study

The study is expected to continue until September 2029. Participants will be monitored for any changes in their condition and for any side effects of the treatment.

Secondary outcomes, such as overall survival and time to progression, are also assessed to provide a comprehensive understanding of the treatment’s impact.

Who Can Join the Study?

  • Must be a female patient.
  • Must have newly diagnosed, high-risk advanced ovarian cancer, specifically BRCA mutated high-grade serous or high-grade endometrioid ovarian cancer, primary peritoneal cancer, and/or fallopian-tube cancer.
  • Must have completed first-line platinum-based chemotherapy. This means treatment with drugs like carboplatin or cisplatin, given through a vein or directly into the abdomen.
  • For patients with Stage III cancer, there must have been one attempt at surgery to remove as much of the tumor as possible, either before or after starting chemotherapy.
  • For patients with Stage IV cancer, there must have been either a biopsy or surgery to remove as much of the tumor as possible, either before or after starting chemotherapy.
  • Must have a documented mutation in the BRCA1 or BRCA2 genes that is known or suspected to be harmful.
  • Must have shown a complete or partial response to the first-line platinum-based chemotherapy, meaning the cancer has shrunk or disappeared, and there is no sign of the disease getting worse on a scan or through a blood test called CA-125.
  • Patients with stable disease, meaning the cancer has not changed, are not eligible.

Who Cannot Join the Study?

  • Patients who do not have a BRCA mutation. A BRCA mutation is a change in a specific gene that can increase the risk of certain cancers.
  • Patients who do not have advanced ovarian cancer at FIGO Stage III-IV. FIGO stages are used to describe how much cancer has spread.
  • Patients who are not in a clinical complete response or partial response after their first treatment with platinum-based chemotherapy. A complete response means no signs of cancer, and a partial response means the cancer has shrunk but is still there.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are not considered part of a vulnerable population. This term refers to groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Hopital Tenon Paris France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
MD Anderson Cancer Center Madrid Spain
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
Hospital Clinico Universitario De Valencia Valencia Spain
Hospital Universitario Reina Sofía Cordoba Spain
Netherlands Cancer Institute Amsterdam The Netherlands
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
L’Hopital Prive Du Confluent Nantes France
Iaucgs Idpzqbvl Feszlscypmewm Ojoyjoagrnb Rome Italy
Izsstqyh Coonxy Dsdosupewslrambom L'hospitalet De Llobregat Spain
Iezhfltm Bnoadgwl Bordeaux France
Nukj Ikuvpbtggnm Mvybcawz Rdeuvzenz Sjov Grzepnica Poland
Nefmranp Inxwpedt Olxkqnzcw Ibv Mhxvw Sexdzukombiapdhcoiiltgealiub Imwsncqn Bpoqoxax Cracow Poland
Fnwcljhxr Ppxq Lo Ioxgugwfmngiz Bbveqehyx Dlu Hudxteoh Utxfqbmjkzvps Ly Pse Madrid Spain
Hqooxfzo Vslk docctill Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
09.02.2024
Italy Italy
Not recruiting
09.02.2024
Poland Poland
Not recruiting
09.02.2024
Spain Spain
Not recruiting
09.02.2024
The Netherlands The Netherlands
Not recruiting
09.02.2024

Trial locations

Investigated drugs:

Olaparib is a medication used in this clinical trial as a maintenance therapy for patients with advanced ovarian cancer who have a specific genetic mutation known as BRCA. After these patients have completed their initial treatment with platinum-based chemotherapy and have shown a complete or partial response, olaparib is given to help prevent the cancer from coming back. It works by interfering with the cancer cells’ ability to repair their DNA, which can help to slow down or stop the growth of the cancer.

Investigated diseases:

BRCA Mutated Advanced Ovarian Cancer – This is a type of ovarian cancer characterized by mutations in the BRCA1 or BRCA2 genes, which are involved in DNA repair. It typically occurs at an advanced stage, specifically FIGO Stage III or IV, indicating that the cancer has spread beyond the ovaries to other parts of the abdomen or beyond. The disease often presents with symptoms such as abdominal bloating, pelvic pain, and changes in bowel habits. As the cancer progresses, it may lead to the accumulation of fluid in the abdomen and difficulty eating. The progression of the disease is monitored using criteria like the Response Evaluation Criteria in Solid Tumours (RECIST). This type of cancer is often treated with chemotherapy, and its progression is assessed by measuring the time until the disease worsens or spreads further.

Trial ID:
2024-511142-39-00
Protocol code:
SOLO 1-D0818C00001
NCT ID:
NCT01844986
Trial Phase:
Therapeutic confirmatory (Phase III)

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