AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

NCT00976911 | Completed Phase 3 Results

• 2 other identifiers: MO222242009-011400-33
• Study Type: interventional
• Target: 361
• Locations: 14 countries
• Sites: 117

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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)

  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)

  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)

  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)

  Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)

Study Arms (2)

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.

Drug: liposomal doxorubicin; Drug: paclitaxel; Drug: topotecan

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.

Drug: Bevacizumab; Drug: liposomal doxorubicin; Drug: paclitaxel; Drug: topotecan

Interventions

Bevacizumab DRUG

10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks

Also known as: Avastin

Chemotherapy + Bevacizumab

liposomal doxorubicin DRUG

40mg/m2 iv every 4 weeks

Chemotherapy; Chemotherapy + Bevacizumab

paclitaxel DRUG

80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle

Chemotherapy; Chemotherapy + Bevacizumab

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

Chemotherapy; Chemotherapy + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients, \>/=18 years of age
• epithelial ovarian, fallopian tube or primary peritoneal cancer
• platinum-resistant disease (disease progression within \<6 months of platinum therapy)
• EOCG performance status of 0-2

You may not qualify if:

• non-epithelial tumours
• ovarian tumours with low malignant potential
• previous treatment with \>2 chemotherapy regimens
• prior radiotherapy to the pelvis or abdomen

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (117)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Clinique Ste-Elisabeth

Namur, 5000, Belgium

Location

University Clinical Centre of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

Clinic of Oncology, University Clinical Center Sarajevo

Sarajevo, 7100, Bosnia and Herzegovina

Location

University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition

Tuzla, 75000, Bosnia and Herzegovina

Location

Herlev Hospital; Afdeling for Kræftbehandling

Herlev, 2730, Denmark

Location

Regionshospitalet Herning; Onkologisk afdeling

Herning, 7400, Denmark

Location

Rigshospitalet; Onkologisk Klinik

København Ø, 2100, Denmark

Location

Odense Universitetshospital, Onkologisk Afdeling R

Odense C, 5000, Denmark

Location

Kuopio University Hospital

Kuopio, 70211, Finland

Location

Oulu University Hospital; Gynaecology & Obstetrics Dept

Oulu, 90220, Finland

Location

Clinique Sainte Catherine; Hopital De Semaine

Avignon, 84918, France

Location

Clinique Tivoli; Sce Radiotherapie

Bordeaux, 33000, France

Location

Institut Bergonie; Gynecologie

Bordeaux, 33076, France

Location

Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

Bordeaux, 33077, France

Location

Ch De Brive La Gaillarde; Radiotherapie Oncologie

Brive-la-Gaillarde, 19312, France

Location

Centre Francois Baclesse; Urologie Gynecologie

Caen, 14076, France

Location

Centre Jean Perrin; Hopital De Jour

Clermont-Ferrand, 63011, France

Location

Hopital Louis Pasteur; Medecine B

Colmar, 68024, France

Location

Institut Daniel Hollard; Chimiotherapie Ambulatoire

Grenoble, 38000, France

Location

Centre Hospitalier Departemental Les Oudairies

La Roche-sur-Yon, 85925, France

Location

Hopital La Source; Onco Med Hematologie Clinique

La Source, 45100, France

Location

Hopital Andre Mignot; Hematologie - Oncologie

Le Chesnay, 78157, France

Location

Centre Jean Bernard

Le Mans, 72015, France

Location

Centre Oscar Lambret; Cancerologie Gynecologique

Lille, 59020, France

Location

Clin Mut De Lyon Eugene Andre; Medecine 3 A

Lyon, 69424, France

Location

Hopital Layne; Medecine Ambulatoire

Mont-de-Marsan, 40024, France

Location

Centre Val Aurelle Paul Lamarque; Medecine A1 A2

Montpellier, 34298, France

Location

Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

Nancy, 54100, France

Location

Centre Catherine de Sienne; Chimiotherapie

Nantes, 44202, France

Location

Centre Antoine Lacassagne; Hopital De Jour A2

Nice, 06189, France

Location

Polyclinique Kenval ; Radiotherapie Oncologie

Nîmes, 30900, France

Location

Hotel Dieu; Hematologie- Oncologie

Paris, 75181, France

Location

Institut Curie; Oncologie Medicale

Paris, 75231, France

Location

Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

Paris, 75475, France

Location

HOPITAL TENON; Cancerologie Medicale

Paris, 75970, France

Location

Clinique Francheville; Radiotherapie

Périgueux, 24000, France

Location

Institut Jean Godinot; Oncologie Medicale

Reims, 51056, France

Location

Centre Henri Becquerel; Oncologie Medicale

Rouen, 76038, France

Location

Clinique Armoricaine Radiologie; Cons Externes

Saint-Brieuc, 22015, France

Location

Centre Rene Huguenin; Medecine B

Saint-Cloud, 92210, France

Location

Ico Rene Gauducheau; Oncologie

Saint-Herblain, 44805, France

Location

Centre Radiotherapie Etienne Dolet

Saint-Nazaire, 44600, France

Location

Hopital Civil; Expl Fonct Systeme Nerveux

Strasbourg, 67091, France

Location

Hopitaux Du Leman Site Thonon; Maternite Gynecologie

Thonon-les-Bains, 74203, France

Location

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, 31059, France

Location

Centre Alexis Vautrin; Oncologie Medicale

Vandœuvre-lès-Nancy, 54519, France

Location

HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

Berlin, 13125, Germany

Location

Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie

Berlin, 13353, Germany

Location

Evangelischen Krankenhauses Düsseldorf; Frauenklinik

Düsseldorf, 40217, Germany

Location

Uni-Frauenklinik

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Erlangen; Frauenklinik

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

Essen, 45122, Germany

Location

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

Essen, 45136, Germany

Location

Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

Frankfurt, 60596, Germany

Location

Kath.Marienkrankenhaus gGmbH Frauenklinik

Hamburg, 22087, Germany

Location

Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

Hanover, 30177, Germany

Location

Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz

Hildesheim, 31134, Germany

Location

Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

Kassel, 34125, Germany

Location

UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

Kiel, 24105, Germany

Location

HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe

Krefeld, 47805, Germany

Location

Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

Lübeck, 23538, Germany

Location

Universitätsklinikum Mannheim; Frauenklinik

Mannheim, 68167, Germany

Location

Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

München, 81377, Germany

Location

Klinikum Nord Frauenklinik

Nuremberg, 90419, Germany

Location

Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

Offenbach, 63069, Germany

Location

Oncologianova GmbH

Recklinghausen, 45659, Germany

Location

Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

Rostock, 18059, Germany

Location

Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe

Solingen, 42653, Germany

Location

Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum

Stuttgart, 70376, Germany

Location

Universitätsklinik Tübingen; Frauenklinik & Poliklinik

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

Ulm, 89075, Germany

Location

Dr. Horst-Schmidt-Kliniken; Frauenheilkunde & Geburtshilfe

Wiesbaden, 65199, Germany

Location

University Hospital of Alexandra

Athens, 11528, Greece

Location

Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

Aviano, Friuli Venezia Giulia, 33081, Italy

Location

A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

Udine, Friuli Venezia Giulia, 33100, Italy

Location

AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia

Rome, Lazio, 00161, Italy

Location

Istituto Regina Elena; Oncologia Medica A

Rome, Lazio, 00168, Italy

Location

Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia

Rome, Lazio, 00186, Italy

Location

Ospedali Riuniti; Divisione Ostetricia e Ginecologia

Bergamo, Lombardy, 24128, Italy

Location

Az. Osp. Carlo Poma; Divisione Di Oncologia Medica

Mantova, Lombardy, 46100, Italy

Location

Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

Milan, Lombardy, 20133, Italy

Location

Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases

Amersfoort, 3818 ES, Netherlands

Location

Catharina ZKHS; Inwendige Geneeskunde Afd.

Eindhoven, 5623 EJ, Netherlands

Location

Martini Ziekenhuis; Dept of Internal Medicine

Groningen, 9728 NT, Netherlands

Location

Stichting St. Antonius Ziekenhuis

Nieuwegein, 3430 EM, Netherlands

Location

Leyenburg Ziekenhuis; Internal Medecine

The Hague, 2545 CH, Netherlands

Location

Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.

Utrecht, 3584 CX, Netherlands

Location

The Norvegian Radium Hospital Montebello; Dept of Oncology

Oslo, 0379, Norway

Location

St. Olavs Hospital; Kvinneklinikken

Trondheim, 7006, Norway

Location

IPO de Lisboa; Servico de Oncologia Medica

Lisbon, 1099-023, Portugal

Location

IPO do Porto; Servico de Oncologia Medica

Porto, 4200-072, Portugal

Location

Hospital Son Llatzer; Servicio de Oncologia

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, 8208, Spain

Location

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, 14004, Spain

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Barcelona, 08041, Spain

Location

Hospital de Terrassa; Servicio de Oncologia

Barcelona, 08227, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

Lleida, 25198, Spain

Location

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, 28007, Spain

Location

Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

Madrid, 28033, Spain

Location

Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

Madrid, 28050, Spain

Location

Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

Murcia, 30008, Spain

Location

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, 46009, Spain

Location

Hospital Universitario la Fe; Servicio de Oncologia

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, 50009, Spain

Location

Uni Hospital Linkoeping; Dept. of Oncology

Linköping, 58185, Sweden

Location

Örebro University Hospital; Department of Gynecologic Oncology

Örebro, 70185, Sweden

Location

Norrlands Uni Hospital; Onkologi Avd.

Umeå, 901 85, Sweden

Location

Akademiska sjukhuset, Onkologkliniken

Uppsala, 751 85, Sweden

Location

Adana Baskent University Hospital; Medical Oncology

Adana, 01120, Turkey (Türkiye)

Location

Ankara Baskent University Medicine Faculty; Gynaecology

Ankara, 06500, Turkey (Türkiye)

Location

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Istanbul, 34300, Turkey (Türkiye)

Location

Anadolu Health Center; Medical Oncology

Kocaeli, 41400, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 37407274 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.

  PMID: 37185961 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.

  PMID: 28595285 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.

  PMID: 28481967 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.

  PMID: 27871723 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.

  PMID: 24687829 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.

  PMID: 24637997 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab; liposomal doxorubicin; Paclitaxel; Topotecan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 15, 2009
• Study Start: October 29, 2009
• Primary Completion: July 9, 2014
• Study Completion: July 9, 2014
• Last Updated: June 21, 2022
• Results First Posted: February 25, 2015

Record last verified: 2022-05

Locations

BE (4); BO (3); PT (2); SE (4); ES (15); DE (26); DK (4); GR (1); FI (2); NL (6); TU (4); FR (36); NO (2); IT (8)