Study on Olaparib and Bevacizumab for Patients with Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer

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What is this study about?

This clinical trial is focused on studying advanced stages of certain types of cancer, specifically ovarian cancer, fallopian tube cancer, and peritoneal cancer. These cancers are at a high grade and advanced stage, known as FIGO Stage III-IV. The study involves two medications: Olaparib and Bevacizumab. Olaparib, also known by its code name AZD-2281, is a type of medication that inhibits an enzyme called PARP, which is involved in repairing damaged DNA in cells. Bevacizumab, sometimes referred to by code names like BI 695502 or RHUMAB-VEGF, is a humanized monoclonal antibody that works by inhibiting the growth of blood vessels that supply nutrients to tumors.

The purpose of this study is to better understand how these medications can benefit patients with these types of cancers after they have received standard first-line treatment. The study will explore the status of a condition called HRD, which stands for homologous recombination deficiency, a situation where cancer cells are less able to repair DNA damage. Participants will receive Olaparib in combination with Bevacizumab to see if this combination can provide additional benefits. The study is non-randomized and open-label, meaning all participants will know which treatment they are receiving, and it is designed to gather information prospectively, or looking forward in time.

Participants in the study will follow a treatment plan that includes taking Olaparib orally and receiving Bevacizumab through intravenous use. The study will last for a period of time, with regular monitoring to assess the effects of the treatment. The main goal is to determine how well the HRD status can be identified using different tests and to see how this status affects the treatment outcomes. The study will also look at the progression-free survival and overall survival of participants, as well as any side effects experienced during the trial. The trial is expected to continue until 2028.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.

A signed informed consent form is required before any study-specific procedures begin.

2 initial assessment

A formalin-fixed, paraffin-embedded tumor sample from the primary cancer is collected for central HRD testing.

Normal organ and bone marrow function are assessed through blood tests.

3 treatment initiation

Treatment begins with the administration of olaparib and bevacizumab.

Olaparib is taken orally, while bevacizumab is administered intravenously.

4 treatment schedule

Olaparib is taken twice daily, with the dosage determined by the healthcare provider.

Bevacizumab is given every three weeks, with the dosage and duration specified by the healthcare provider.

5 monitoring and follow-up

Regular monitoring includes assessments of disease progression and response to treatment.

Progression-free survival and overall survival are evaluated.

6 adverse event assessment

Any adverse events or side effects are recorded and assessed according to established criteria.

Regular evaluations of vital signs, ECG results, and laboratory parameters are conducted.

7 completion

The trial is expected to conclude by November 2028.

Final assessments will determine the overall outcomes and benefits of the treatment.

Who Can Join the Study?

Must be a female who is 18 years or older.
Must have an ECOG performance status of 0-1, which means being fully active or having some symptoms but still able to carry out light work.
Must have a life expectancy of at least 16 weeks.
Must be post-menopausal or have a negative pregnancy test if pre-menopausal. Post-menopausal means having no menstrual periods for a year or more due to natural causes or medical treatments.
Must be able to understand and sign a consent form agreeing to the study’s requirements.
Must have a newly diagnosed advanced stage of high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian-tube cancer.
Must have completed a specific type of chemotherapy before joining the study, which includes a minimum of 6 cycles of platinum-taxane chemotherapy and at least 3 cycles of Bevacizumab.
Must show no signs of disease or be in complete or partial response after the first-line treatment, meaning the cancer has not progressed.
Must join the study between 4 to 8 weeks after the last chemotherapy dose, with most side effects resolved to a mild level.
Must provide a sample of the primary cancer for testing.
Must have normal organ and bone marrow function, which includes specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, and kidney function.

Who Cannot Join the Study?

Patients with other types of cancer that are not the specific types mentioned in the study.
Patients who have not been diagnosed with the specific stages of cancer mentioned in the study.
Patients who are not within the age range specified for the study.
Patients who do not meet the gender requirements for the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Iaqesgeb Cypdkm Dvtlrwwbdzevszrhv	L'hospitalet De Llobregat	Spain
Hhhgziue Voel dmedesyr	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	31.05.2024

Trial locations

Investigated drugs:

Olaparib is a medication used in this trial to help treat patients with advanced ovarian, fallopian tube, or peritoneal cancer. It works by interfering with the cancer cells’ ability to repair their DNA, which can lead to the death of these cells. This medication is often used in combination with other treatments to improve its effectiveness.

Bevacizumab is another medication involved in the trial. It is used to slow the growth of new blood vessels that tumors need to grow and spread. By blocking this process, bevacizumab can help to control the cancer and prevent it from getting worse. It is often used alongside other cancer treatments to enhance their effects.

Investigated diseases:

Advanced FIGO Stage III-IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer – This disease refers to a group of cancers that originate in the ovaries, fallopian tubes, or peritoneum and have progressed to an advanced stage. It is characterized by the presence of high-grade serous or endometrioid cancer cells, which are aggressive and tend to grow and spread rapidly. At this stage, the cancer has typically spread beyond the pelvis to other parts of the abdomen or even to distant organs. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits. The progression of the disease is often monitored through imaging and clinical evaluations.

Trial ID:

2024-517363-24-00

Protocol code:

ESR-20-21103

NCT ID:

NCT06377267

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Olaparib and Bevacizumab for Patients with Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer

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