Study on Niraparib for Maintenance Treatment in Patients with Advanced Ovarian Cancer After Initial Chemotherapy Response

3 1 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called niraparib in patients with advanced ovarian cancer. Ovarian cancer is a type of cancer that begins in the ovaries, which are part of the female reproductive system. The study is specifically looking at patients who have a type of ovarian cancer known as homologous recombination deficiency, which means their cancer cells have trouble repairing DNA damage. The treatment being tested is niraparib tosylate monohydrate, which is taken as a capsule by mouth. This medication is being compared to a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how effective niraparib is in maintaining the response to initial chemotherapy treatment in patients with advanced ovarian cancer. Patients who have responded well to their first round of chemotherapy, which is a common cancer treatment using drugs to kill cancer cells, will be given either niraparib or a placebo. The study will monitor how long patients remain free from cancer progression, which means the cancer does not get worse, after starting the study treatment.

Participants in the study will take the study medication for up to 36 months, or until their cancer progresses or they experience unacceptable side effects. Throughout the study, patients will have regular check-ups to monitor their health and the status of their cancer. The study aims to provide valuable information on whether niraparib can help keep ovarian cancer from returning or worsening after initial treatment.

1 randomization

After meeting the eligibility criteria, the patient is randomly assigned to one of two groups: one receiving niraparib and the other receiving a placebo. This process is double-blind, meaning neither the patient nor the researchers know which group the patient is in.

2 treatment initiation

The patient begins taking the assigned medication. If assigned to the niraparib group, the patient takes niraparib tosilate monohydrate orally. The dosage is determined by the study protocol and is taken daily.

If assigned to the placebo group, the patient takes a placebo capsule that looks identical to the niraparib capsule, also taken daily.

3 treatment duration

The treatment continues as long as the patient does not experience disease progression or unacceptable side effects. The duration is determined by the study protocol and the patient’s response to the treatment.

4 progress monitoring

Throughout the study, the patient’s health and response to the treatment are regularly monitored. This includes assessments of disease progression and any side effects experienced.

The primary measure of success is progression-free survival (PFS), which is the time from randomization to disease progression or death.

5 completion of treatment

Once the treatment phase is completed, the patient may continue to be monitored for additional outcomes, such as overall survival and quality of life measures.

Follow-up assessments are conducted at specified intervals, such as 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the end of treatment.

Who Can Join the Study?

  • Patients must be female and at least 18 years old.
  • Patients must be able to understand the study procedures and agree to participate by signing a written consent form.
  • Patients who can have children must have a negative pregnancy test within 7 days before starting the study treatment.
  • Patients must be postmenopausal (no periods for over a year), surgically unable to have children, or willing to use effective birth control or avoid pregnancy-related activities during the study and for 180 days after the last dose of treatment.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • Patients must be able to take medications by mouth.
  • Patients must have adequate organ function, which includes specific blood and kidney function levels:
    • White blood cells (neutrophils) count of at least 1,500 per microliter.
    • Platelet count of at least 100,000 per microliter.
    • Hemoglobin level of at least 10 grams per deciliter.
    • Kidney function (serum creatinine) within 1.5 times the normal limit or a creatinine clearance of at least 60 mL/min.
    • Total bilirubin within 1.5 times the normal limit.
    • Liver enzymes (AST and ALT) within 2.5 times the normal limit, or 5 times if there are liver metastases.
  • All patients must agree to complete Patient-Reported Outcomes (PROs) during the study and at specific times after the end of treatment.
  • Patients must have available tumor samples from the primary cancer or agree to a new biopsy before starting the study treatment.
  • Patients must have a specific type of ovarian, fallopian tube, or primary peritoneal cancer that is Stage III or IV according to the FIGO criteria.
  • Patients with inoperable Stage III and IV disease, operable Stage IV disease, or those treated with chemotherapy and surgery are eligible.
  • Patients must have received between 6 and 9 cycles of platinum-based chemotherapy and have a complete or partial response after at least 3 cycles.
  • Patients must have a CA-125 level in the normal range or a significant decrease during therapy that remains stable.
  • Patients must be randomized within 12 weeks of the last chemotherapy cycle.
  • All patients must agree to undergo central tumor HRD testing (a test to check for specific genetic changes in the tumor).

Who Cannot Join the Study?

  • Patients who do not have advanced ovarian cancer with homologous recombination deficiency. This means the cancer has specific genetic characteristics.
  • Patients who have not had a complete response or partial response to initial 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 present.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population that the study does not include.

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
Karolinska Institutet Solna Sweden
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitair Ziekenhuis Gent Gent Belgium
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
Centre Hospitalier Lyon Sud Pierre Benite France
CHU Saint Pierre Brussels Belgium
Hospital Del Mar Barcelona Spain
Az Maria Middelares Gent Gent Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
University Hospital Waterford Waterford Ireland
Vitaz Sint-Niklaas Belgium
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
MD Anderson Cancer Center Madrid Spain
Fakultni Nemocnice Plzen Plzen Czechia
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Ospedale San Raffaele S.r.l. Milan Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
University Hospital Galway Galway Ireland
Turku University Hospital Turku Finland
Aalborg University Hospital Aalborg Denmark
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Rigshospitalet Copenhagen Denmark
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Klinikum Fuerth Anstalt des Oeffentlichen Rechts der Stadt Fuerth Fürth Germany
Cofnywawe Upjkatqveqwmxc Sfplwuaqo Woluwe-Saint-Lambert Belgium
Idmgnaag Rbzjhsqz Dh Cpuzxh Dt Mehbfxqmrje Montpellier France
Iqkcpwus Cbheyh Dmvzmxjeurpxeyllu L'hospitalet De Llobregat Spain
Hlelzp Hfnypcxw Herlev Denmark
Gsjdlsxnceleqtimb Vbsoydwjm Pwjt Agehyx Eqgrxdle Ofvznh Kxczfa Gyor Hungary
Hjbcvwfw Uffrrgtbcwitl Dxitwopt Donostia / San Sebastian Spain
Figrkewfm Pqod Ld Ilwuyksxbqowq Birpmuiya Dxa Hlgeylch Uujvpazzgtprb Lu Pko Madrid Spain
Kcveltju Euywpnctmkuvjffpovbpimfd Hsoautkgmxwywerhg Essen Germany
Hfvhvoxp Vdcj dquesyxf Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
14.09.2016
Czechia Czechia
Not recruiting
14.09.2016
Denmark Denmark
Not recruiting
14.09.2016
Finland Finland
Not recruiting
14.09.2016
France France
Not recruiting
14.09.2016
Germany Germany
Not recruiting
14.09.2016
Hungary Hungary
Not recruiting
14.09.2016
Ireland Ireland
Not recruiting
14.09.2016
Italy Italy
Not recruiting
14.09.2016
Poland Poland
Not recruiting
14.09.2016
Spain Spain
Not recruiting
14.09.2016
Sweden Sweden
Not recruiting
14.09.2016

Trial locations

Niraparib is a medication used in this clinical trial as a maintenance treatment for patients with advanced ovarian cancer. It is given to patients who have already responded well to initial chemotherapy with platinum-based drugs. The goal of using niraparib is to help keep the cancer from coming back or getting worse, which is known as prolonging progression-free survival.

Investigated diseases:

Homologous recombination deficiency advanced ovarian cancer – This is a type of ovarian cancer characterized by a deficiency in the homologous recombination repair pathway, which is crucial for repairing DNA double-strand breaks. This deficiency can lead to genomic instability and tumor progression. The cancer typically affects the ovaries but can also involve the fallopian tubes and peritoneum. It is often diagnosed at an advanced stage, such as Stage III or IV, where the cancer has spread beyond the ovaries. The progression of this cancer can be influenced by genetic mutations, such as those in the BRCA1 or BRCA2 genes, which are involved in DNA repair. The disease may initially respond to chemotherapy, but there is a risk of recurrence or progression over time.

Trial ID:
2023-508010-42-00
Protocol code:
PR-30-5017-C
NCT ID:
NCT02655016
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Phase 3 Study of LY4170156 (Sofetabart Mipitecan) with drug combination in platinum‑resistant and platinum‑sensitive ovarian cancer patients

    Recruiting

    3 1 1 1
    Austria Belgium Czechia Denmark France Germany +9
  • A study to evaluate the use of [68Ga]BED003 for imaging colorectal, gastric, pancreatic, breast, and ovarian cancers.

    Recruiting

    2 1 1
    Investigated diseases:
    Italy The Netherlands