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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011400-33 | EudraCT Number |
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This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Active Comparator | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks [q3w]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. |
|
| Chemotherapy + Bevacizumab | Experimental | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) | Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011 |
| Progression Free Survival (PFS; Data Cutoff 14 November 2011) | PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley. | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011) | Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | 1000 | Belgium | |||
| UZ Antwerpen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37407274 | Derived | Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3. | |
| 37185961 | Derived | Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks [q3w]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| liposomal doxorubicin | Drug | 40mg/m2 iv every 4 weeks |
|
| paclitaxel | Drug | 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle |
|
| topotecan | Drug | 4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle |
|
| Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011 |
| Duration of Objective Response (Data Cutoff 14 November 2011) | For randomized participants who achieved an objective response per modified RECIST, duration of objective response was defined as the time from the date of the first occurrence of a CR or PR (whichever occurred first) until the date that progressive disease or death was documented (whichever occurred first). Participants who had an objective response and did not experience disease progression or death by the time of analysis were censored at the time of the last tumor assessment. Summaries of duration of objective response (median and percentiles) were estimated from Kaplan-Meier curves. 95% CI for duration of objective response was computed using the method of Brookmeyer and Crowley. | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011 |
| Percentage of Participants Who Died (Data Cutoff 25 January 2013) | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013 |
| Overall Survival (Data Cutoff 25 January 2013) | Duration of overall survival was defined as the time from randomization to death of any cause. Kaplan-Meier methodology was used. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. 95% CI was computed using the method of Brookmeyer and Crowley. | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013 |
| European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011) | The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline. | Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011) |
| Edegem |
| 2650 |
| Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Clinique Ste-Elisabeth | Namur | 5000 | Belgium |
| University Clinical Centre of the Republic of Srpska | Banja Luka | 78000 | Bosnia and Herzegovina |
| Clinic of Oncology, University Clinical Center Sarajevo | Sarajevo | 7100 | Bosnia and Herzegovina |
| University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition | Tuzla | 75000 | Bosnia and Herzegovina |
| Herlev Hospital; Afdeling for Kræftbehandling | Herlev | 2730 | Denmark |
| Regionshospitalet Herning; Onkologisk afdeling | Herning | 7400 | Denmark |
| Rigshospitalet; Onkologisk Klinik | København Ø | 2100 | Denmark |
| Odense Universitetshospital, Onkologisk Afdeling R | Odense C | 5000 | Denmark |
| Kuopio University Hospital | Kuopio | 70211 | Finland |
| Oulu University Hospital; Gynaecology & Obstetrics Dept | Oulu | 90220 | Finland |
| Clinique Sainte Catherine; Hopital De Semaine | Avignon | 84918 | France |
| Clinique Tivoli; Sce Radiotherapie | Bordeaux | 33000 | France |
| Institut Bergonie; Gynecologie | Bordeaux | 33076 | France |
| Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie | Bordeaux | 33077 | France |
| Ch De Brive La Gaillarde; Radiotherapie Oncologie | Brive-la-Gaillarde | 19312 | France |
| Centre Francois Baclesse; Urologie Gynecologie | Caen | 14076 | France |
| Centre Jean Perrin; Hopital De Jour | Clermont-Ferrand | 63011 | France |
| Hopital Louis Pasteur; Medecine B | Colmar | 68024 | France |
| Institut Daniel Hollard; Chimiotherapie Ambulatoire | Grenoble | 38000 | France |
| Centre Hospitalier Departemental Les Oudairies | La Roche-sur-Yon | 85925 | France |
| Hopital La Source; Onco Med Hematologie Clinique | La Source | 45100 | France |
| Hopital Andre Mignot; Hematologie - Oncologie | Le Chesnay | 78157 | France |
| Centre Jean Bernard | Le Mans | 72015 | France |
| Centre Oscar Lambret; Cancerologie Gynecologique | Lille | 59020 | France |
| Clin Mut De Lyon Eugene Andre; Medecine 3 A | Lyon | 69424 | France |
| Hopital Layne; Medecine Ambulatoire | Mont-de-Marsan | 40024 | France |
| Centre Val Aurelle Paul Lamarque; Medecine A1 A2 | Montpellier | 34298 | France |
| Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE | Nancy | 54100 | France |
| Centre Catherine de Sienne; Chimiotherapie | Nantes | 44202 | France |
| Centre Antoine Lacassagne; Hopital De Jour A2 | Nice | 06189 | France |
| Polyclinique Kenval ; Radiotherapie Oncologie | Nîmes | 30900 | France |
| Hotel Dieu; Hematologie- Oncologie | Paris | 75181 | France |
| Institut Curie; Oncologie Medicale | Paris | 75231 | France |
| Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset) | Paris | 75475 | France |
| HOPITAL TENON; Cancerologie Medicale | Paris | 75970 | France |
| Clinique Francheville; Radiotherapie | Périgueux | 24000 | France |
| Institut Jean Godinot; Oncologie Medicale | Reims | 51056 | France |
| Centre Henri Becquerel; Oncologie Medicale | Rouen | 76038 | France |
| Clinique Armoricaine Radiologie; Cons Externes | Saint-Brieuc | 22015 | France |
| Centre Rene Huguenin; Medecine B | Saint-Cloud | 92210 | France |
| Ico Rene Gauducheau; Oncologie | Saint-Herblain | 44805 | France |
| Centre Radiotherapie Etienne Dolet | Saint-Nazaire | 44600 | France |
| Hopital Civil; Expl Fonct Systeme Nerveux | Strasbourg | 67091 | France |
| Hopitaux Du Leman Site Thonon; Maternite Gynecologie | Thonon-les-Bains | 74203 | France |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | 31059 | France |
| Centre Alexis Vautrin; Oncologie Medicale | Vandœuvre-lès-Nancy | 54519 | France |
| HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe | Berlin | 13125 | Germany |
| Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie | Berlin | 13353 | Germany |
| Evangelischen Krankenhauses Düsseldorf; Frauenklinik | Düsseldorf | 40217 | Germany |
| Uni-Frauenklinik | Düsseldorf | 40225 | Germany |
| Universitätsklinikum Erlangen; Frauenklinik | Erlangen | 91054 | Germany |
| Universitätsklinikum Essen; Zentrum Für Frauenheilkunde | Essen | 45122 | Germany |
| Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum | Essen | 45136 | Germany |
| Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe | Frankfurt | 60596 | Germany |
| Kath.Marienkrankenhaus gGmbH Frauenklinik | Hamburg | 22087 | Germany |
| Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding | Hanover | 30177 | Germany |
| Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz | Hildesheim | 31134 | Germany |
| Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe | Kassel | 34125 | Germany |
| UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe | Kiel | 24105 | Germany |
| HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe | Krefeld | 47805 | Germany |
| Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe | Lübeck | 23538 | Germany |
| Universitätsklinikum Mannheim; Frauenklinik | Mannheim | 68167 | Germany |
| Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde | München | 81377 | Germany |
| Klinikum Nord Frauenklinik | Nuremberg | 90419 | Germany |
| Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe | Offenbach | 63069 | Germany |
| Oncologianova GmbH | Recklinghausen | 45659 | Germany |
| Universitätsfrauen- und Poliklinik am Klinikum Suedstadt | Rostock | 18059 | Germany |
| Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe | Solingen | 42653 | Germany |
| Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum | Stuttgart | 70376 | Germany |
| Universitätsklinik Tübingen; Frauenklinik & Poliklinik | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm Am Michelsberg; Frauenklinik | Ulm | 89075 | Germany |
| Dr. Horst-Schmidt-Kliniken; Frauenheilkunde & Geburtshilfe | Wiesbaden | 65199 | Germany |
| University Hospital of Alexandra | Athens | 11528 | Greece |
| Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia | Udine | Friuli Venezia Giulia | 33100 | Italy |
| AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia | Rome | Lazio | 00161 | Italy |
| Istituto Regina Elena; Oncologia Medica A | Rome | Lazio | 00168 | Italy |
| Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia | Rome | Lazio | 00186 | Italy |
| Ospedali Riuniti; Divisione Ostetricia e Ginecologia | Bergamo | Lombardy | 24128 | Italy |
| Az. Osp. Carlo Poma; Divisione Di Oncologia Medica | Mantua | Lombardy | 46100 | Italy |
| Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica | Milan | Lombardy | 20133 | Italy |
| Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases | Amersfoort | 3818 ES | Netherlands |
| Catharina ZKHS; Inwendige Geneeskunde Afd. | Eindhoven | 5623 EJ | Netherlands |
| Martini Ziekenhuis; Dept of Internal Medicine | Groningen | 9728 NT | Netherlands |
| Stichting St. Antonius Ziekenhuis | Nieuwegein | 3430 EM | Netherlands |
| Leyenburg Ziekenhuis; Internal Medecine | The Hague | 2545 CH | Netherlands |
| Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd. | Utrecht | 3584 CX | Netherlands |
| The Norvegian Radium Hospital Montebello; Dept of Oncology | Oslo | 0379 | Norway |
| St. Olavs Hospital; Kvinneklinikken | Trondheim | 7006 | Norway |
| IPO de Lisboa; Servico de Oncologia Medica | Lisbon | 1099-023 | Portugal |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| Hospital Son Llatzer; Servicio de Oncologia | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona | 8208 | Spain |
| Hospital Universitario Marques de Valdecilla; Servicio de Oncologia | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | 08041 | Spain |
| Hospital de Terrassa; Servicio de Oncologia | Barcelona | 08227 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia | Lleida | 25198 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28007 | Spain |
| Centro Oncologico MD Anderson Internacional; Servicio de Oncologia | Madrid | 28033 | Spain |
| Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica | Madrid | 28050 | Spain |
| Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia | Murcia | 30008 | Spain |
| Instituto Valenciano Oncologia; Oncologia Medica | Valencia | 46009 | Spain |
| Hospital Universitario la Fe; Servicio de Oncologia | Valencia | 46026 | Spain |
| Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | 50009 | Spain |
| Uni Hospital Linkoeping; Dept. of Oncology | Linköping | 58185 | Sweden |
| Örebro University Hospital; Department of Gynecologic Oncology | Örebro | 70185 | Sweden |
| Norrlands Uni Hospital; Onkologi Avd. | Umeå | 901 85 | Sweden |
| Akademiska sjukhuset, Onkologkliniken | Uppsala | 751 85 | Sweden |
| Adana Baskent University Hospital; Medical Oncology | Adana | 01120 | Turkey (Türkiye) |
| Ankara Baskent University Medicine Faculty; Gynaecology | Ankara | 06500 | Turkey (Türkiye) |
| Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | 34300 | Turkey (Türkiye) |
| Anadolu Health Center; Medical Oncology | Kocaeli | 41400 | Turkey (Türkiye) |
| 28595285 | Derived | Roncolato FT, Gibbs E, Lee CK, Asher R, Davies LC, Gebski VJ, Friedlander M, Hilpert F, Wenzel L, Stockler MR, King M, Pujade-Lauraine E. Quality of life predicts overall survival in women with platinum-resistant ovarian cancer: an AURELIA substudy. Ann Oncol. 2017 Aug 1;28(8):1849-1855. doi: 10.1093/annonc/mdx229. |
| 28481967 | Derived | Bamias A, Gibbs E, Khoon Lee C, Davies L, Dimopoulos M, Zagouri F, Veillard AS, Kosse J, Santaballa A, Mirza MR, Tabaro G, Vergote I, Bloemendal H, Lykka M, Floquet A, Gebski V, Pujade-Lauraine E. Bevacizumab with or after chemotherapy for platinum-resistant recurrent ovarian cancer: exploratory analyses of the AURELIA trial. Ann Oncol. 2017 Aug 1;28(8):1842-1848. doi: 10.1093/annonc/mdx228. |
| 27871723 | Derived | Sorio R, Roemer-Becuwe C, Hilpert F, Gibbs E, Garcia Y, Kaern J, Huizing M, Witteveen P, Zagouri F, Coeffic D, Luck HJ, Gonzalez-Martin A, Kristensen G, Levache CB, Lee CK, Gebski V, Pujade-Lauraine E; AURELIA Investigators. Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial. Gynecol Oncol. 2017 Jan;144(1):65-71. doi: 10.1016/j.ygyno.2016.11.006. Epub 2016 Nov 18. |
| 24687829 | Derived | Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. doi: 10.1200/JCO.2013.51.4240. Epub 2014 Mar 31. |
| 24637997 | Derived | Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17. |
| FG001 | Chemotherapy + Bevacizumab | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. |
| BG001 | Chemotherapy + Bevacizumab | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) | Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. | ITT Population: All participants randomized to study treatment, irrespective of whether or not the assigned treatment was actually received. For all efficacy analyses, participants were grouped according to the treatment assigned at randomization | Posted | Number | percentage of participants | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011 |
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| Secondary | Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011) | Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution. | ITT Population; only participants with measurable disease at baseline were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011 |
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| Secondary | Duration of Objective Response (Data Cutoff 14 November 2011) | For randomized participants who achieved an objective response per modified RECIST, duration of objective response was defined as the time from the date of the first occurrence of a CR or PR (whichever occurred first) until the date that progressive disease or death was documented (whichever occurred first). Participants who had an objective response and did not experience disease progression or death by the time of analysis were censored at the time of the last tumor assessment. Summaries of duration of objective response (median and percentiles) were estimated from Kaplan-Meier curves. 95% CI for duration of objective response was computed using the method of Brookmeyer and Crowley. | ITT Population; only participants with a best overall confirmed response of CR or PR were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011 |
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| Secondary | Percentage of Participants Who Died (Data Cutoff 25 January 2013) | ITT Population | Posted | Number | percentage of participants | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013 |
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| Primary | Progression Free Survival (PFS; Data Cutoff 14 November 2011) | PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley. | ITT Population; only participants with an event of progression or death were included in the analysis | Posted | Median | 95% Confidence Interval | months | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011 |
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| Secondary | Overall Survival (Data Cutoff 25 January 2013) | Duration of overall survival was defined as the time from randomization to death of any cause. Kaplan-Meier methodology was used. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. 95% CI was computed using the method of Brookmeyer and Crowley. | ITT Population; only participants who died were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013 |
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| Secondary | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011) | The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline. | ITT population; n (number) = (equals) number of participants that completed the questionnaire at baseline and at the specified visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011) |
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Adverse Events (AEs) were recorded at every treatment visit and all follow-up visits until 2 months after the final follow-up visit (up to approximately 4 years).
Only Grade 2-5 AEs according to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) were recorded per the protocol. The safety population included all treated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chemotherapy | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. | 49 | 181 | 129 | 181 | ||
| EG001 | Chemotherapy + Bevacizumab | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. | 56 | 179 | 146 | 179 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | NCTCAE, Version 3.0, | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vesical fistula | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | NCTCAE, Version 3.0, | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemorrhagic ascites | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCTCAE, Version 3.0, | Non-systematic Assessment |
| |
| Catheter site necrosis | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| General symptom | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Infectious peritonitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Wrong drug administered | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cytoreductive surgery | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | NCTCAE, Version 3.0, | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | NCTCAE, Version 3.0, | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann- LaRoche | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C506643 | liposomal doxorubicin |
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| OG001 | Chemotherapy + Bevacizumab | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. |
|
|
|
| OG001 | Chemotherapy + Bevacizumab | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. |
|
|
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|
|
| OG001 | Chemotherapy + Bevacizumab | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. |
|
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|
| OG001 | Chemotherapy + Bevacizumab | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. |
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