AzTrials
AzTrials

Ovarian CancerPhase 3PAOLA-1NCT02477644

Platine, Avastin and OLAparib in 1st Line

A Phase 3 study testing Olaparib in people with Ovarian Cancer, run by Arcagy Research at 163 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Olaparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
806 participants
Where
163 sitesin 11 countries
Study dates
6 May 2015to 22 Mar 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 25Show fewer
  • I-4. Patient who has completed prior to randomization first line platinum-taxane chemotherapy:
  • 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.
  • 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:
  • Hemoglobin ≥ 10.0 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
  • Platelet count ≥ 100 x 109/L.
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
  • 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.
  • Serum creatinine ≤ 1.25 x institutional ULN and creatinine clearance > 50 mL/min.
  • 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.
  • Urine dipstick for proteinuria < 2+. If urine dipstick i s ≥2+, 24-hour urine must demonstrate <1 g of protein in 24 hours.
  • 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.

Who cannot join

  • 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:
  • stage < II,
  • 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.
Show all 31Show fewer
  • 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:
  • Myocardial infarction or unstable angina within ≤ 6 months of randomization,
  • New York Heart Association (NYHA) ≥ grade 2congestive heart failure (CHF).
  • Poorly controlled cardiac arrhythmia despite medication (patient with rate controlled atrial fibrillation are eligible), or any clinically significant abnormal finding on resting ECG,
  • 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).

Trial locations and contacts

163 sites in 11 countries.

163 sites in 11 countries

Germany59 sites

  • Klinikum Aschaffenburg

    Aschaffenburg, 63739

  • Klinikum Augsburg

    Augsburg, 86156

  • Hochtaunus-Kliniken

    Bad Homburg, 61352

  • Praxisklinik Krebsheilkunde für Frauen

    Berlin, 10367

  • HELIOS Klinikum Berlin-Buch

    Berlin, 13125

  • Charité - Universitätsmedizin Berlin (CVK)

    Berlin, 13353

  • Onkologie Bottrop

    Bottrop, 46236

  • GYNAEKOLOGICUM Bremen

    Bremen, 28111

  • Universitätsfrauenklinik Köln

    Cologne, 50931

  • St. Elisabeth Krankenhaus

    Cologne, 50935

  • Städtisches Klinikum Dessau

    Dessau, 06847

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf, 40217

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsfrauenklinik Erlangen

    Erlangen, 91054

  • Kliniken Essen Mitte

    Essen, 45136

  • Universitätsklinikum Essen

    Essen, 45147

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Klinikum der Johann Wolfgang Goethe-Universität

    Frankfurt, 60590

  • Klinikum Frankfurt Höchst

    Frankfurt, 65929

  • Universitätsfrauenklinik Freiburg

    Freiburg im Breisgau, 79106

  • Universitäts-Frauenklinik Göttingen

    Göttingen, 37075

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Klinkum Gütersloh

    Gütersloh, 33332

  • Universitätsklinikum Halle

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Albertinen Krankenhaus

    Hamburg, 22457

  • Gynäkologisch-Onkologische Praxis Hannover

    Hanover, 30177

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Jena

    Jena, 07743

  • St. Vincentius Kliniken

    Karlsruhe, 76135

  • Klinikum Kassel

    Kassel, 34125

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Klinikum Konstanz

    Konstanz, 78462

  • HELIOS Klinikum Krefeld

    Krefeld, 47805

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Klinikum Ludwigsburg

    Ludwigsburg, 71640

  • Universitätsklinikum Gießen und Marburg

    Marburg, 35043

  • Johannes Wesling Klinikum

    Minden, 32429

  • Klinikum der Universität München

    München, 81377

  • Klinikum rechts der Isar

    München, 81675

  • Universitätsklinikum Münster

    Münster, 48149

  • Kliniken des Landkreises Neumarkt

    Neumarkt, 92318

  • Sana Klinikum Offenbach

    Offenbach, 63069

  • Ortenau Klinikum

    Offenburg, 77654

  • Onkologie Ravensburg

    Ravensburg, 88212

  • Universitätsfrauenklinik Regensburg

    Regensburg, 93053

  • Klinikum am Steinenberg

    Reutlingen, 72764

  • ROMed Klinikum Rosenheim

    Rosenheim, 83022

  • Klinikum Südstadt

    Rostock, 18059

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Universitäts-Frauenklinik Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89075

  • HELIOS Dr. Horst Schmidt Kliniken

    Wiesbaden, 65199

  • Marien Hospital Witten

    Witten, 58452

  • amO Wolfsburg

    Wolfsburg, 38440

  • Klinikum Worms

    Worms, 67550

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

France43 sites

  • ICO Paul Papin

    Angers, 49100

  • Institut Sainte-Catherine

    Avignon, 84918

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord

    Bordeaux, 33300

  • Centre François Baclesse

    Caen, 14000

  • Centre Jean Perrin

    Clermont-Ferrand, 63000

  • Centre Georges François Leclerc

    Dijon, 21079

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38028

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon, 85925

  • Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble

    La Tronche, 38700

  • Centre Jean Bernard - Clinique Victor Hugo

    Le Mans, 72000

  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez

    Lille, 59037

  • Centre Oscar Lambret

    Lille, 59200

  • Centre Léon Bérard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13009

  • Hôpital de Mont-de-Marsan

    Mont-de-Marsan, 40024

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Centre Azuréen de Cancérologie

    Mougins, 06250

  • Centre Catherine de Sienne - Group confluent

    Nantes, 44202

  • Centre Antoine Lacassagne

    Nice, 06189

  • Centre Hospitalier Régional d'Orléans

    Orléans, 45067

  • Hôpital Européen Georges Pompidou

    Paris, Ilhe de France, 75015

  • Institut Curie - Hopital Claudius Régaud

    Paris, 75005

  • Hôpital des Diaconesses

    Paris, 75012

  • Hôpital Cochin

    Paris, 75014

  • Hopital Tenon

    Paris, 75020

  • Groupe Hospitalier Saint-Joseph

    Paris, 75674

  • Clinique Francheville

    Périgueux, 20004

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre CARIO - HPCA

    Plérin, 22190

  • Hôpital de la Milétrie - CHU de Poitiers - Pôle Régional de Cancérologie

    Poitiers, 86021

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Hôpital René Huguenin, Institut Curie

    Saint-Cloud, 92210

  • ICO Centre René Gauducheau

    Saint-Herblain, 44805

  • Centre de Radiothérapie - Clinique Sainte-Anne

    Strasbourg, 67000

  • Centre Paul Strauss

    Strasbourg, 67065

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67200

  • Institut Claudius Regaud

    Toulouse, 31059

  • Clinique Pasteur - ONCOSUD

    Toulouse, 31076

  • ICL Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy20 sites

  • Centro Riferimento Oncologico

    Aviano, 33081

  • Policlinico S.Orsola-Malpighi

    Bologna, 40138

  • Spedali Civili-Università di Brescia

    Brescia, 25120

  • Ospedale Senatore Antonio Perrino

    Brindisi, 72100

  • EO Ospedali Galliera

    Genova, 16128

  • Ospedale San Luca

    Lucca, 55100

  • Istituto Nazionale Tumori

    Milan, 20133

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Istituto Nazionale Tumori - IRCCS Pascale

    Naples, 80131

  • Istituto Oncologico Veneto

    Padova, 35128

  • Ospedale Santa Maria della Misericordia

    Perugia, 06122

  • Ospedale Santa Chiara

    Pisa, 56124

  • AO ASL 4 - Ospedale di Prato

    Prato, 59100

  • Arcispedale S. M. Nuova

    Reggio Emilia, 42100

  • Istituto Regina Elena

    Roma, 00144

  • Policlinico Umberto I La Sapienza

    Roma, 00161

  • Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

    Roma, 00168

  • Ospedale S. Anna

    Torino, 10126

  • Ospedale Mauriziano

    Torino, 10128

  • Ospedale Santa Chiara

    Trento, 38100

Other trials in Italy

Spain14 sites

  • H. U. Fundación Alcorcón

    Alcorcón, 28922

  • H. de la Santa Creu i Sant Pau

    Barcelona, 8026

  • C.S. Parc Taulí

    Barcelona, 8208

  • H. U. Reina Sofía

    Córdoba, 14004

  • H.U. Arnau de Vilanova

    Lleida, 25198

  • MD Anderson Cancer Center Madrid

    Madrid, 28033

  • H. U. Ramón y Cajal

    Madrid, 28034

  • H. U. 12 de Octubre

    Madrid, 28041

  • H.U. Central de Asturias

    Oviedo, 33011

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • H. General Universitario de Valencia

    Valencia, 46014

  • H. U. P. La Fe

    Valencia, 46026

  • H. U. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Japan7 sites

  • Ehime University Hospital

    Ehime, 791-0204

  • Hyogo Cancer Center

    Hyōgo, 673-0021

  • University of Tsukuba Hospital

    Ibaraki, 305-0005

  • Kagoshima University Medical And Dental Hospital

    Kagoshima, 890-8520

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Jichi Medical University Hospital

    Tochigi, 329-0498

  • National Cancer Center Hospital

    Tokyo, 104-0045

Other trials in Japan

Austria6 sites

  • KH der Barmherzigen Brüder Graz

    Graz, 8020

  • Medical University of Graz

    Graz, 8036

  • Medical University of Innsbruck

    Innsbruck, 6020

  • Landeskrankenhaus Salzburg

    Salzburg, 5020

  • Medical University of Vienna

    Vienna, 1090

  • Krankenhaus Hietzing

    Vienna, 1130

Other trials in Austria

Belgium6 sites

  • Institut Jules Bordet

    Brussels, B1000

  • Antwerp University Hospital

    Edegem, B-2650

  • UZ Gasthuisberg

    Leuven, B - 3000

  • Hôpital de la Citadelle

    Liège, B-4000

  • Clinique et maternité Sainte Elisabeth

    Namur, B-5000

  • CHU Dinant Godinne

    Yvoir, B-5530

Other trials in Belgium

Finland4 sites

  • Kuopio University Hospital

    Kuopio, 70210

  • Oulu University Hospital

    Oulu, FIN-90029

  • Tampere University Hospital

    Tampere, FI-33521

  • Turku University Hospital

    Turku

Other trials in Finland

Denmark2 sites

  • Rigshospitalet

    Copenhagen, 2100

  • Herlev Hospital

    Herlev, 2720

Other trials in Denmark

Monaco1 site

  • Centre Hospitalier Princesse Grace

    Monaco, 98000

Other trials in Monaco

Sweden1 site

  • Linköping University Hospital

    Linköping, 58185

Other trials in Sweden

About this study

Official title: Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment

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.

Read the detailed description

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
Ovarian Cancer
Being tested
Olaparib, Placebo
Keywords
Advanced FIGO IIIB, IV high grade serious ovarian cancer, endometrioid ovarian cancer, standard first-line treatment, platinum-taxane chemotherapy, bevacizumab, olaparib, placebo
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Tablets, per os, 300 mg twice daily;

  • PlaceboDrug

    Tablets, per os, 300 mg twice daily.

Study groups in NCT02477644
Study groupRoleWhat they receive
OlaparibExperimentalTablets per os 300 mg
Receives: Drug: Olaparib
PlaceboPlacebo comparatorTablets per os 300 mg
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy by progression free survival (PFS1)

    Measured: phase up to a total of 15 months

Secondary outcomes (7)

  1. Overall survival

    Overall survival is defined as the time from the date of randomization until death due to any cause.

    Measured: Study end

  2. Time to earliest progression by RECIST or CA-125

    Time to earliest progression by RECIST v. 1.1 or CA-125 or death is defined as the time from randomization to the earliest date of RECIST or CA-125 progression or death by any cause.

    Measured: Study end

  3. Second Progression Free Survival (PFS2)

    Time from randomization to second progression is defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the primary variable PFS, or date of death.

    Measured: Study end

  4. Time to start of first subsequent therapy or death (TFST)

    Time to start of first subsequent therapy or death (TFST) will be assessed. TFST is defined as the time from the date of randomization to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death.

    Measured: Study end

  5. Time to start of second subsequent therapy or death (TSST)

    Time to start of second subsequent therapy or death (TSST) will be assessed. TSST is defined as the time from the date of randomization to the earliest of the date of second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.

    Measured: Study end

  6. Safety and Tolerability

    Measured: Study end

  7. Patient reported outcome

    Measured: 2 years after last patient included

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2015 (estimated)
  2. Study start6 May 2015
  3. Primary completion22 Mar 2019
  4. Study completion22 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02477644
Sponsor's protocol ID
GINECO-OV125b
Acronym
PAOLA-1
Status last verified
Aug 2022
First submitted
18 Jun 2015
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31851799

  • Perrier L, Zarca K, Cadet T, Morelle M, Cropet C, Burges A, Cecere SC, Palacio I, Abdeddaim C, Durand-Zaleski I, Ray-Coquard I. Economic evaluation alongside the PAOLA-1 /ENGOT-ov25 trial: cost of ovarian cancer and cost-effectiveness of olaparib plus bevacizumab first-line maintenance. Cost Eff Resour Alloc. 2026 Aug 6;24(1):135. doi: 10.1186/s12962-026-00810-4.

    PubMed 42977994

  • Joly F, Anota A, Chabaud S, Cropet C, Priou F, Harter P, Pignata S, Palacio I, Petru E, Kobayashi H, Vergote I, Parma G, Maenpaa J, Raymond E, Ataseven B, Pisano C, Lainez N, Tsibulak I, Yonemori K, Vuylsteke P, Lapresa MT, Mirza MR, Bouchaert P, Buderath P, Lorusso D, Herrero A, Eberst L, Burges A, Scambia G, Ortega E, Guillemet C, Pujade-Lauraine E, Kurtz JE, Ray-Coquard I. Health-related quality of life in patients with newly diagnosed advanced ovarian cancer receiving maintenance olaparib plus bevacizumab (PAOLA-1/ENGOT-ov25). J Natl Cancer Inst. 2026 Apr 24:djag122. doi: 10.1093/jnci/djag122. Online ahead of print.

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  • 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.

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  • 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.

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  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olaparib in people with Ovarian Cancer, run by Arcagy Research at 163 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in Germany, France, Italy, Spain, Japan and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy by progression free survival (PFS1) (time frame: phase up to a total of 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02477644, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.

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