Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
806 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-05-06
Study Completion Date
2022-03-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT02446600
Fallopian Tube Clear Cell Adenocarcinoma
Fallopian Tube Transitional Cell Carcinoma
Fallopian Tube Undifferentiated Carcinoma
+10 more
ACTIVE_NOT_RECRUITING
PHASE3
Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer
NCT01650376
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Uterine Cancer
UNKNOWN
PHASE1/PHASE2
First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients
NCT06121401
Carcinoma, Ovarian Epithelial
ACTIVE_NOT_RECRUITING
PHASE4
Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients
NCT03402841
Non-Germline BRCA Mutated Ovarian Cancer
COMPLETED
PHASE3
Neoadjuvant Therapy in Advanced Ovarian Cancer With Avastin
NCT01847677
Cancer, Ovarian
TERMINATED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients with advanced FIGO stage IIIB - IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer treated with standard first-line treatment, combining platinum-taxane chemotherapy and bevacizumab concurrent with chemotherapy and in maintenance.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Ovarian Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Olaparib
Tablets per os 300 mg
Group Type
EXPERIMENTAL
Olaparib
Intervention Type
DRUG
Tablets, per os, 300 mg twice daily;
Placebo
Tablets per os 300 mg
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Tablets, per os, 300 mg twice daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Olaparib
Tablets, per os, 300 mg twice daily;
Intervention Type
DRUG
Placebo
Tablets, per os, 300 mg twice daily.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
I-1. Female Patient must be ≥18 years of age. I-2. Signed informed consent and ability to comply with treatment and follow-up.
I-3. Patient with newly diagnosed I-3-1 Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer,
I-3-2 Histologically confirmed (based on local histopathological findings):
* high grade serous or
* high grade endometrioid or
* other epithelial non mucinous ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation I-3-3 at an advanced stage: FIGO stage IIIB, IIIC, or IV of the 1988 FIGO classification.
I-4. Patient who has completed prior to randomization first line platinum-taxane chemotherapy:
1. Platinum-taxane based regimen must have consisted of a minimum of 6 treatment cycles and a maximum of 9. However if platinum based therapy must be discontinued early as a result of non hematological toxicity specifically related to the platinum regimen, (i.e. neurotoxicity, hypersensitivity etc.), patient must have received a minimum of 4 cycles of the platinum regimen.
2. Intravenous, intraperitoneal, or neoadjuvant platinum based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle. Interval debulking is allowed.
I-5. Patient must have received prior to randomization a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of platinum-based chemotherapy. Only in case of interval debulking surgery, it is allowed to realize only 2 cycles of bevacizumab in combination with the last 3 cycles of platinium-based chemotherapy. Bevacizumab treatment should be administered at a dose 15mg/kg q3 weeks up to a total of 15 months.
I-6. Patient must be prior to randomization without evidence of disease (NED) or in complete response (CR) or partial response (PR) from her first line treatment. There should be no clinical evidence of disease progression (physical exam, imagery, CA 125) throughout her first line treatment and prior to study randomization.
I-7. Patient must be randomized at least 3 weeks and no more than 9 weeks after her last dose of chemotherapy (last dose is the day of the last infusion) and all major toxicities from the previous chemotherapy must have resolved to CTC AE grade 1 or better (except alopecia and peripheral neuropathy).
I-8. Patient must have normal organ and bone marrow function:
1. Hemoglobin ≥ 10.0 g/dL.
2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
3. Platelet count ≥ 100 x 109/L.
4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
5. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.
6. Serum creatinine ≤ 1.25 x institutional ULN and creatinine clearance \> 50 mL/min.
7. Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN.
The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization.
8. Urine dipstick for proteinuria \< 2+. If urine dipstick i s ≥2+, 24-hour urine must demonstrate \<1 g of protein in 24 hours.
9. Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).
I-9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. I-10. Formalin fixed, paraffin embedded (FFPE) tumor sample from the primary cancer must be available for central BRCA testing and test result must be available for stratification.
I-11. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. (see appendix 4) I-12. For France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category.
I-3. Patient with newly diagnosed I-3-1 Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer,
I-3-2 Histologically confirmed (based on local histopathological findings):
* high grade serous or
* high grade endometrioid or
* other epithelial non mucinous ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation I-3-3 at an advanced stage: FIGO stage IIIB, IIIC, or IV of the 1988 FIGO classification.
I-4. Patient who has completed prior to randomization first line platinum-taxane chemotherapy:
1. Platinum-taxane based regimen must have consisted of a minimum of 6 treatment cycles and a maximum of 9. However if platinum based therapy must be discontinued early as a result of non hematological toxicity specifically related to the platinum regimen, (i.e. neurotoxicity, hypersensitivity etc.), patient must have received a minimum of 4 cycles of the platinum regimen.
2. Intravenous, intraperitoneal, or neoadjuvant platinum based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle. Interval debulking is allowed.
I-5. Patient must have received prior to randomization a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of platinum-based chemotherapy. Only in case of interval debulking surgery, it is allowed to realize only 2 cycles of bevacizumab in combination with the last 3 cycles of platinium-based chemotherapy. Bevacizumab treatment should be administered at a dose 15mg/kg q3 weeks up to a total of 15 months.
I-6. Patient must be prior to randomization without evidence of disease (NED) or in complete response (CR) or partial response (PR) from her first line treatment. There should be no clinical evidence of disease progression (physical exam, imagery, CA 125) throughout her first line treatment and prior to study randomization.
I-7. Patient must be randomized at least 3 weeks and no more than 9 weeks after her last dose of chemotherapy (last dose is the day of the last infusion) and all major toxicities from the previous chemotherapy must have resolved to CTC AE grade 1 or better (except alopecia and peripheral neuropathy).
I-8. Patient must have normal organ and bone marrow function:
1. Hemoglobin ≥ 10.0 g/dL.
2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
3. Platelet count ≥ 100 x 109/L.
4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
5. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.
6. Serum creatinine ≤ 1.25 x institutional ULN and creatinine clearance \> 50 mL/min.
7. Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN.
The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization.
8. Urine dipstick for proteinuria \< 2+. If urine dipstick i s ≥2+, 24-hour urine must demonstrate \<1 g of protein in 24 hours.
9. Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).
I-9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. I-10. Formalin fixed, paraffin embedded (FFPE) tumor sample from the primary cancer must be available for central BRCA testing and test result must be available for stratification.
I-11. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. (see appendix 4) I-12. For France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category.
Exclusion Criteria
E-1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
E-2. Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma.
E-3. Patient with synchronous primary endometrial cancer unless both of the following criteria are met:
1. stage \< II,
2. Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade III endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1 or 2 endometrioid adenocarcinoma.
Patient with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium is not eligible.
E-4. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS). Patient with a history of localized malignancy diagnosed over 5 years ago may be eligible provided she completed her adjuvant systemic therapy prior to randomization and that the patient remains free of recurrent or metastatic disease.
Patient with history of primary triple negative breast cancer may be eligible provided she completed her definitive anticancer treatment more than 3 years ago and she remains breast cancer disease free prior to start of study treatment.
E-5. Patient with myelodysplastic syndrome/acute myeloid leukemia history E-6. Patient having experienced for at least one cycle, a delay \> 2 weeks due to prolonged hematological recovery during the first line chemotherapy E-7. Patient receiving radiotherapy within 6 weeks prior to study treatment E-8. Major surgery within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery E-9. Previous allergenic bone marrow transplant. E-10. Any previous treatment with PARP inhibitor, including olaparib. E-11. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).
E-12. Current or recent (within 10 days prior to randomization) chronic use of aspirin \> 325 mg/day.
E-13. Concomitant use of known potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
E-14. Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
E-15. Clinically significant (e.g. active) cardiovascular disease, including:
1. Myocardial infarction or unstable angina within ≤ 6 months of randomization,
2. New York Heart Association (NYHA) ≥ grade 2congestive heart failure (CHF).
3. Poorly controlled cardiac arrhythmia despite medication (patient with rate controlled atrial fibrillation are eligible), or any clinically significant abnormal finding on resting ECG,
4. Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living \[ADL\] requiring repair or revision).
E-16. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub- Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.
E-17. History or evidence of hemorrhagic disorders within 6 months prior to randomization.
E-18. Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
E-19. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression.
E-20. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
E-21. Significant traumatic injury during 4 weeks prior to randomization. E-22. Non-healing wound, active ulcer or bone fracture. Patient with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection is eligible but require 3 weekly wound examinations.
E-23. History of VEGF therapy related abdominal fistula or gastrointestinal perforation or active gastrointestinal bleeding within 6 months prior to the first study treatment.
E-24. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
E-25. Patient with evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
E-26. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.
E-27. Pregnant or lactating women. E-28. Participation in another clinical study with an investigational product during her chemotherapy course immediately prior to randomization.
E-29. Patient unable to swallow orally administered medication and patient with gastrointestinal disorders likely to interfere with absorption of the study medication.
E-30. Patient with a known hypersensitivity to olaparib or any of the recipients of the product.
E-31. Immunocompromised patient, e.g., with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids or patient who is known to be serologically positive for human immunodeficiency virus (HIV).
E-2. Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma.
E-3. Patient with synchronous primary endometrial cancer unless both of the following criteria are met:
1. stage \< II,
2. Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade III endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1 or 2 endometrioid adenocarcinoma.
Patient with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium is not eligible.
E-4. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS). Patient with a history of localized malignancy diagnosed over 5 years ago may be eligible provided she completed her adjuvant systemic therapy prior to randomization and that the patient remains free of recurrent or metastatic disease.
Patient with history of primary triple negative breast cancer may be eligible provided she completed her definitive anticancer treatment more than 3 years ago and she remains breast cancer disease free prior to start of study treatment.
E-5. Patient with myelodysplastic syndrome/acute myeloid leukemia history E-6. Patient having experienced for at least one cycle, a delay \> 2 weeks due to prolonged hematological recovery during the first line chemotherapy E-7. Patient receiving radiotherapy within 6 weeks prior to study treatment E-8. Major surgery within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery E-9. Previous allergenic bone marrow transplant. E-10. Any previous treatment with PARP inhibitor, including olaparib. E-11. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).
E-12. Current or recent (within 10 days prior to randomization) chronic use of aspirin \> 325 mg/day.
E-13. Concomitant use of known potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
E-14. Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
E-15. Clinically significant (e.g. active) cardiovascular disease, including:
1. Myocardial infarction or unstable angina within ≤ 6 months of randomization,
2. New York Heart Association (NYHA) ≥ grade 2congestive heart failure (CHF).
3. Poorly controlled cardiac arrhythmia despite medication (patient with rate controlled atrial fibrillation are eligible), or any clinically significant abnormal finding on resting ECG,
4. Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living \[ADL\] requiring repair or revision).
E-16. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub- Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.
E-17. History or evidence of hemorrhagic disorders within 6 months prior to randomization.
E-18. Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
E-19. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression.
E-20. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
E-21. Significant traumatic injury during 4 weeks prior to randomization. E-22. Non-healing wound, active ulcer or bone fracture. Patient with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection is eligible but require 3 weekly wound examinations.
E-23. History of VEGF therapy related abdominal fistula or gastrointestinal perforation or active gastrointestinal bleeding within 6 months prior to the first study treatment.
E-24. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
E-25. Patient with evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
E-26. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.
E-27. Pregnant or lactating women. E-28. Participation in another clinical study with an investigational product during her chemotherapy course immediately prior to randomization.
E-29. Patient unable to swallow orally administered medication and patient with gastrointestinal disorders likely to interfere with absorption of the study medication.
E-30. Patient with a known hypersensitivity to olaparib or any of the recipients of the product.
E-31. Immunocompromised patient, e.g., with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids or patient who is known to be serologically positive for human immunodeficiency virus (HIV).
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany
OTHER
Sponsor Role
collaborator
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
OTHER
Sponsor Role
collaborator
Grupo Español de Investigación en Cáncer de Ovario
OTHER
Sponsor Role
collaborator
Belgian Gynaecological Oncology Group
OTHER
Sponsor Role
collaborator
Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies
UNKNOWN
Sponsor Role
collaborator
Mario Negri Gynecologic Oncology group (MaNGO)
OTHER
Sponsor Role
collaborator
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
OTHER
Sponsor Role
collaborator
Gynecologic Oncology Trial & Investigation Consortium
NETWORK
Sponsor Role
collaborator
Arcagy Research
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isabelle RAY COQUARD, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
KH der Barmherzigen Brüder Graz
Graz, , Austria
Site Status
Medical University of Graz
Graz, , Austria
Site Status
Medical University of Innsbruck
Innsbruck, , Austria
Site Status
Landeskrankenhaus Salzburg
Salzburg, , Austria
Site Status
Medical University of Vienna
Vienna, , Austria
Site Status
Krankenhaus Hietzing
Vienna, , Austria
Site Status
Institut Jules Bordet
Brussels, , Belgium
Site Status
Antwerp University Hospital
Edegem, , Belgium
Site Status
UZ Gasthuisberg
Leuven, , Belgium
Site Status
Hôpital de la Citadelle
Liège, , Belgium
Site Status
Clinique et maternité Sainte Elisabeth
Namur, , Belgium
Site Status
CHU Dinant Godinne
Yvoir, , Belgium
Site Status
Rigshospitalet
Copenhagen, , Denmark
Site Status
Herlev Hospital
Herlev, , Denmark
Site Status
Kuopio University Hospital
Kuopio, , Finland
Site Status
Oulu University Hospital
Oulu, , Finland
Site Status
Tampere University Hospital
Tampere, , Finland
Site Status
Turku University Hospital
Turku, , Finland
Site Status
Hôpital Européen Georges Pompidou
Paris, Ilhe de France, France
Site Status
ICO Paul Papin
Angers, , France
Site Status
Institut Sainte-Catherine
Avignon, , France
Site Status
Hôpital Jean Minjoz
Besançon, , France
Site Status
Institut Bergonié
Bordeaux, , France
Site Status
Polyclinique Bordeaux Nord
Bordeaux, , France
Site Status
Centre François Baclesse
Caen, , France
Site Status
Centre Jean Perrin
Clermont-Ferrand, , France
Site Status
Centre Georges François Leclerc
Dijon, , France
Site Status
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, , France
Site Status
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, , France
Site Status
Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble
La Tronche, , France
Site Status
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, , France
Site Status
Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez
Lille, , France
Site Status
Centre Oscar Lambret
Lille, , France
Site Status
Centre Léon Bérard
Lyon, , France
Site Status
Institut Paoli Calmettes
Marseille, , France
Site Status
Hôpital de Mont-de-Marsan
Mont-de-Marsan, , France
Site Status
ICM Val d'Aurelle
Montpellier, , France
Site Status
Centre Azuréen de Cancérologie
Mougins, , France
Site Status
Centre Catherine de Sienne - Group confluent
Nantes, , France
Site Status
Centre Antoine Lacassagne
Nice, , France
Site Status
Centre Hospitalier Régional d'Orléans
Orléans, , France
Site Status
Institut Curie - Hopital Claudius Régaud
Paris, , France
Site Status
Hôpital des Diaconesses
Paris, , France
Site Status
Hôpital Cochin
Paris, , France
Site Status
Hopital Tenon
Paris, , France
Site Status
Groupe Hospitalier Saint-Joseph
Paris, , France
Site Status
Clinique Francheville
Périgueux, , France
Site Status
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Site Status
Centre CARIO - HPCA
Plérin, , France
Site Status
Hôpital de la Milétrie - CHU de Poitiers - Pôle Régional de Cancérologie
Poitiers, , France
Site Status
Centre Eugène Marquis
Rennes, , France
Site Status
Centre Henri Becquerel
Rouen, , France
Site Status
Hôpital René Huguenin, Institut Curie
Saint-Cloud, , France
Site Status
ICO Centre René Gauducheau
Saint-Herblain, , France
Site Status
Centre de Radiothérapie - Clinique Sainte-Anne
Strasbourg, , France
Site Status
Centre Paul Strauss
Strasbourg, , France
Site Status
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Site Status
Institut Claudius Regaud
Toulouse, , France
Site Status
Clinique Pasteur - ONCOSUD
Toulouse, , France
Site Status
ICL Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Site Status
Institut Gustave Roussy
Villejuif, , France
Site Status
Klinikum Aschaffenburg
Aschaffenburg, , Germany
Site Status
Klinikum Augsburg
Augsburg, , Germany
Site Status
Hochtaunus-Kliniken
Bad Homburg, , Germany
Site Status
Praxisklinik Krebsheilkunde für Frauen
Berlin, , Germany
Site Status
HELIOS Klinikum Berlin-Buch
Berlin, , Germany
Site Status
Charité - Universitätsmedizin Berlin (CVK)
Berlin, , Germany
Site Status
Onkologie Bottrop
Bottrop, , Germany
Site Status
GYNAEKOLOGICUM Bremen
Bremen, , Germany
Site Status
Universitätsfrauenklinik Köln
Cologne, , Germany
Site Status
St. Elisabeth Krankenhaus
Cologne, , Germany
Site Status
Städtisches Klinikum Dessau
Dessau, , Germany
Site Status
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Site Status
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, , Germany
Site Status
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Site Status
Universitätsfrauenklinik Erlangen
Erlangen, , Germany
Site Status
Kliniken Essen Mitte
Essen, , Germany
Site Status
Universitätsklinikum Essen
Essen, , Germany
Site Status
Klinikum Esslingen
Esslingen am Neckar, , Germany
Site Status
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, , Germany
Site Status
Klinikum Frankfurt Höchst
Frankfurt, , Germany
Site Status
Universitätsfrauenklinik Freiburg
Freiburg im Breisgau, , Germany
Site Status
Universitäts-Frauenklinik Göttingen
Göttingen, , Germany
Site Status
Universitätsmedizin Greifswald
Greifswald, , Germany
Site Status
Klinkum Gütersloh
Gütersloh, , Germany
Site Status
Universitätsklinikum Halle
Halle, , Germany
Site Status
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Site Status
Albertinen Krankenhaus
Hamburg, , Germany
Site Status
Gynäkologisch-Onkologische Praxis Hannover
Hanover, , Germany
Site Status
Medizinische Hochschule Hannover
Hanover, , Germany
Site Status
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Site Status
Universitätsklinikum Jena
Jena, , Germany
Site Status
St. Vincentius Kliniken
Karlsruhe, , Germany
Site Status
Klinikum Kassel
Kassel, , Germany
Site Status
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Site Status
Klinikum Konstanz
Konstanz, , Germany
Site Status
HELIOS Klinikum Krefeld
Krefeld, , Germany
Site Status
Klinikum Ludwigsburg
Ludwigsburg, , Germany
Site Status
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Site Status
Universitätsklinikum Gießen und Marburg
Marburg, , Germany
Site Status
Johannes Wesling Klinikum
Minden, , Germany
Site Status
Klinikum der Universität München
München, , Germany
Site Status
Klinikum rechts der Isar
München, , Germany
Site Status
Universitätsklinikum Münster
Münster, , Germany
Site Status
Kliniken des Landkreises Neumarkt
Neumarkt, , Germany
Site Status
Sana Klinikum Offenbach
Offenbach, , Germany
Site Status
Ortenau Klinikum
Offenburg, , Germany
Site Status
Onkologie Ravensburg
Ravensburg, , Germany
Site Status
Universitätsfrauenklinik Regensburg
Regensburg, , Germany
Site Status
Klinikum am Steinenberg
Reutlingen, , Germany
Site Status
ROMed Klinikum Rosenheim
Rosenheim, , Germany
Site Status
Klinikum Südstadt
Rostock, , Germany
Site Status
Robert-Bosch-Krankenhaus
Stuttgart, , Germany
Site Status
Universitäts-Frauenklinik Tübingen
Tübingen, , Germany
Site Status
Universitätsklinikum Ulm
Ulm, , Germany
Site Status
HELIOS Dr. Horst Schmidt Kliniken
Wiesbaden, , Germany
Site Status
Marien Hospital Witten
Witten, , Germany
Site Status
amO Wolfsburg
Wolfsburg, , Germany
Site Status
Klinikum Worms
Worms, , Germany
Site Status
Universitätsklinikum Würzburg
Würzburg, , Germany
Site Status
Centro Riferimento Oncologico
Aviano, , Italy
Site Status
Policlinico S.Orsola-Malpighi
Bologna, , Italy
Site Status
Spedali Civili-Università di Brescia
Brescia, , Italy
Site Status
Ospedale Senatore Antonio Perrino
Brindisi, , Italy
Site Status
EO Ospedali Galliera
Genova, , Italy
Site Status
Ospedale San Luca
Lucca, , Italy
Site Status
Istituto Nazionale Tumori
Milan, , Italy
Site Status
Istituto Europeo di Oncologia
Milan, , Italy
Site Status
Istituto Nazionale Tumori - IRCCS Pascale
Napoli, , Italy
Site Status
Istituto Oncologico Veneto
Padua, , Italy
Site Status
Ospedale Santa Maria della Misericordia
Perugia, , Italy
Site Status
Ospedale Santa Chiara
Pisa, , Italy
Site Status
AO ASL 4 - Ospedale di Prato
Prato, , Italy
Site Status
Arcispedale S. M. Nuova
Reggio Emilia, , Italy
Site Status
Istituto Regina Elena
Roma, , Italy
Site Status
Policlinico Umberto I La Sapienza
Roma, , Italy
Site Status
Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore
Roma, , Italy
Site Status
Ospedale S. Anna
Torino, , Italy
Site Status
Ospedale Mauriziano
Torino, , Italy
Site Status
Ospedale Santa Chiara
Trento, , Italy
Site Status
Ehime University Hospital
Ehime, , Japan
Site Status
Hyogo Cancer Center
Hyōgo, , Japan
Site Status
University of Tsukuba Hospital
Ibaraki, , Japan
Site Status
Kagoshima University Medical And Dental Hospital
Kagoshima, , Japan
Site Status
Saitama Medical University International Medical Center
Saitama, , Japan
Site Status
Jichi Medical University Hospital
Tochigi, , Japan
Site Status
National Cancer Center Hospital
Tokyo, , Japan
Site Status
Centre Hospitalier Princesse Grace
Monaco, , Monaco
Site Status
H. U. Fundación Alcorcón
Alcorcón, , Spain
Site Status
H. de la Santa Creu i Sant Pau
Barcelona, , Spain
Site Status
C.S. Parc Taulí
Barcelona, , Spain
Site Status
H. U. Reina Sofía
Córdoba, , Spain
Site Status
H.U. Arnau de Vilanova
Lleida, , Spain
Site Status
MD Anderson Cancer Center Madrid
Madrid, , Spain
Site Status
H. U. Ramón y Cajal
Madrid, , Spain
Site Status
H. U. 12 de Octubre
Madrid, , Spain
Site Status
H.U. Central de Asturias
Oviedo, , Spain
Site Status
Complejo Hospitalario de Navarra
Pamplona, , Spain
Site Status
Instituto Valenciano de Oncología
Valencia, , Spain
Site Status
H. General Universitario de Valencia
Valencia, , Spain
Site Status
H. U. P. La Fe
Valencia, , Spain
Site Status
H. U. Miguel Servet
Zaragoza, , Spain
Site Status
Linköping University Hospital
Linköping, , Sweden
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Austria
Belgium
Denmark
Finland
France
Germany
Italy
Japan
Monaco
Spain
Sweden
References
Explore related publications, articles, or registry entries linked to this study.
Ray-Coquard I, Pautier P, Pignata S, Perol D, Gonzalez-Martin A, Berger R, Fujiwara K, Vergote I, Colombo N, Maenpaa J, Selle F, Sehouli J, Lorusso D, Guerra Alia EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marme F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.
Reference Type
RESULT
Barnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5.
Reference Type
DERIVED
Montegut C, Falandry C, Cinieri S, Cropet C, Montane L, Rousseau F, Joly F, Moubarak M, Mosconi AM, Guerra-Alia EM, Schauer C, Fujiwara H, Vergote I, Parma G, Lindahl G, Anota A, Canzler U, Marme F, Pujade-Lauraine E, Ray-Coquard I, Sabatier R. Safety and quality of life with maintenance olaparib plus bevacizumab in older patients with ovarian cancer: subgroup analysis of PAOLA-1/ENGOT-ov25. Oncologist. 2025 Jul 4;30(7):oyae322. doi: 10.1093/oncolo/oyae322.
Reference Type
DERIVED
Harter P, Marth C, Mouret-Reynier MA, Cropet C, Lorusso D, Guerra-Alia EM, Matsumoto T, Vergote I, Colombo N, Maenpaa J, Lebreton C, de Gregorio N, Mosconi AM, Rubio-Perez MJ, Bourgeois H, Fasching PA, Cecere SC, Hardy-Bessard AC, Denschlag D, de Percin S, Hanker L, Favier L, Bauerschlag D, Desauw C, Hillemanns P, Largillier R, Sehouli J, Grenier J, Pujade-Lauraine E, Ray-Coquard I; PAOLA-1/ENGOT-ov25 investigators. Efficacy of subsequent therapies in patients with advanced ovarian cancer who relapse after first-line olaparib maintenance: results of the PAOLA-1/ENGOT-ov25 trial. Ann Oncol. 2025 Feb;36(2):185-196. doi: 10.1016/j.annonc.2024.10.828. Epub 2024 Nov 9.
Reference Type
DERIVED
Lorusso D, Mouret-Reynier MA, Harter P, Cropet C, Caballero C, Wolfrum-Ristau P, Satoh T, Vergote I, Parma G, Nottrup TJ, Lebreton C, Fasching PA, Pisano C, Manso L, Bourgeois H, Runnebaum I, Zamagni C, Hardy-Bessard AC, Schnelzer A, Fabbro M, Schmalfeldt B, Berton D, Belau A, Lotz JP, Gropp-Meier M, Gladieff L, Luck HJ, Abadie-Lacourtoisie S, Pujade-Lauraine E, Ray-Coquard I. Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial. Int J Gynecol Cancer. 2024 Apr 1;34(4):550-558. doi: 10.1136/ijgc-2023-004995.
Reference Type
DERIVED
Pujade-Lauraine E, Brown J, Barnicle A, Wessen J, Lao-Sirieix P, Criscione SW, du Bois A, Lorusso D, Romero I, Petru E, Yoshida H, Vergote I, Colombo N, Hietanen S, Provansal M, Schmalfeldt B, Pignata S, Martin Lorente C, Berton D, Runnebaum IB, Ray-Coquard I. Homologous Recombination Repair Gene Mutations to Predict Olaparib Plus Bevacizumab Efficacy in the First-Line Ovarian Cancer PAOLA-1/ENGOT-ov25 Trial. JCO Precis Oncol. 2023 Jan;7:e2200258. doi: 10.1200/PO.22.00258.
Reference Type
DERIVED
Gonzalez-Martin A, Desauw C, Heitz F, Cropet C, Gargiulo P, Berger R, Ochi H, Vergote I, Colombo N, Mirza MR, Tazi Y, Canzler U, Zamagni C, Guerra-Alia EM, Levache CB, Marme F, Bazan F, de Gregorio N, Dohollou N, Fasching PA, Scambia G, Rubio-Perez MJ, Milenkova T, Costan C, Pautier P, Ray-Coquard I; PAOLA1/ENGOT-ov25 investigators. Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial. Eur J Cancer. 2022 Oct;174:221-231. doi: 10.1016/j.ejca.2022.07.022. Epub 2022 Sep 5.
Reference Type
DERIVED
Fujiwara K, Fujiwara H, Yoshida H, Satoh T, Yonemori K, Nagao S, Matsumoto T, Kobayashi H, Bourgeois H, Harter P, Mosconi AM, Vazquez IP, Reinthaller A, Fujita T, Rowe P, Pujade-Lauraine E, Ray-Coquard I. Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial. J Gynecol Oncol. 2021 Sep;32(5):e82. doi: 10.3802/jgo.2021.32.e82.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://www.ncbi.nlm.nih.gov/pubmed/31851799
Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GINECO-OV125b
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)
NCT03740165
ACTIVE_NOT_RECRUITING
PHASE3
Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers
NCT03924245
TERMINATED
PHASE1
Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients
NCT04152941
COMPLETED
Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
NCT00262847
COMPLETED
PHASE3
Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy
NCT05295589
WITHDRAWN
PHASE2
Olaparib Maintenance Treatment Versus Placebo in Patients With PSR Ovarian Cancer Who Are in CR or PR to Platinum-based Chemotherapy and Whose Tumours Carry sBRCAm or HRR-associated Genes Mutations
NCT02392676
WITHDRAWN
PHASE3
Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
NCT01844986
ACTIVE_NOT_RECRUITING
PHASE3
D9319C00001- 1L OC Mono Global RCT
NCT04884360
ACTIVE_NOT_RECRUITING
PHASE3
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
NCT01874353
ACTIVE_NOT_RECRUITING
PHASE3
Pazopanib Hydrochloride, Paclitaxel, and Carboplatin in Treating Patients With Refractory or Resistant Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
NCT01402271
COMPLETED
PHASE1/PHASE2
Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
NCT00003644
COMPLETED
PHASE3
Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
NCT01081951
ACTIVE_NOT_RECRUITING
PHASE2
Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer
NCT04742075
RECRUITING
PHASE2
Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
NCT00028743
COMPLETED
PHASE3
Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
NCT00004934
COMPLETED
PHASE3
First-Line Treatment of Bevacizumab, Carboplatin, and Paclitaxel in Treating Participants With Stage III-IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
NCT01097746
COMPLETED
PHASE2
A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
NCT02489006
ACTIVE_NOT_RECRUITING
PHASE2
A Study of Carboplatin, PLD and Everolimus in Certain Gynecologic Cancer
NCT01281514
COMPLETED
PHASE1
Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian Cancer
NCT04417192
COMPLETED
PHASE2
Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
NCT01081262
ACTIVE_NOT_RECRUITING
PHASE3
Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status
NCT02983799
COMPLETED
PHASE2
Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer
NCT03598270
COMPLETED
PHASE3
Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT00866697
COMPLETED
PHASE3
Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer
NCT00170664
COMPLETED
PHASE2