A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma
2 other identifiers
interventional
921
24 countries
133
Brief Summary
This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously \[IV\] once every 2 week \[q2w\]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray \[Gy\], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared \[mg/m\^2\] oral administration \[po\] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m\^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks \[q3w\]) or placebo monotherapy continued. The time on study treatment was until disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2009
Longer than P75 for phase_3
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2009
CompletedFirst Submitted
Initial submission to the registry
July 17, 2009
CompletedFirst Posted
Study publicly available on registry
July 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2013
CompletedResults Posted
Study results publicly available
May 20, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2015
CompletedSeptember 25, 2017
August 1, 2017
3.7 years
July 17, 2009
March 29, 2013
August 25, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator
PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization \[WHO\] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging \[MRI\] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(\>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.
Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)
Co-Primary: Overall Survival (OS)
Overall Survival was defined as the time from randomization to death due to any cause.
Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months])
Secondary Outcomes (5)
PFS as Assessed by an Independent Review Facility
Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months])
Kaplan-Meier (KM) Estimate of One Year Overall Survival
Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])
Kaplan-Meier (KM) Estimate of Two Year Overall Survival
Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])
PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)
Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)
Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death
Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])
Study Arms (2)
Bevacizumab + RT + Temozolomide
EXPERIMENTALIn the Concurrent Phase participants will receive radiotherapy (RT) in daily fractions of 2 Gy to be given 5 days per week for 6 weeks and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (it may continue for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg IV every 2 weeks for 6 weeks. There will be a 4 week treatment break. Participants will then enter the Maintenance Phase where they receive six 28-day cycle of bevacizumab 10 mg/kg IV q2w and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants will then enter the Monotherapy Phase where they will receive bevacizumab 15 mg/kg IV q3w until disease progression/unacceptable toxicity.
Placebo + RT + Temozolomide
PLACEBO COMPARATORIn the Concurrent Phase participants will receive radiotherapy in daily fractions of 2 Gy to be given 5 days per week for 6 weeks and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (it may continue for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There will be a 4 week treatment break. Participants will then enter the Maintenance Phase where they will receive six 28-day cycle of placebo IV q2w and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants will then enter the Monotherapy Phase where they will receive placebo IV q3w until disease progression/unacceptable toxicity.
Interventions
10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase.
75 mg/m\^2 once daily for 6 weeks, followed by 150-200 mg/m\^2 once daily on days 1-5 of six 4 week cycles.
30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.
Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase.
Eligibility Criteria
You may qualify if:
- newly diagnosed glioblastoma
- World Health Organization (WHO) performance status less than or equal to (\<=2)
- stable or decreasing corticosteroid dose within 5 days prior to randomization
You may not qualify if:
- evidence of recent hemorrhage on postoperative magnetic resonance imaging (MRI) of brain
- any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas
- any prior radiotherapy to brain
- clinically significant cardiovascular disease
- history of greater than or equal to (\>=) grade 2 hemoptysis within 1 month prior to randomization
- previous centralized screening for Methylguanine-DNA methyltransferase (MGMT) status for enrollment into a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (133)
University of Alabama At Birmingham; Neuro-Oncology
Birmingham, Alabama, 35294, United States
UCLA
Los Angeles, California, 90095, United States
University of Colorado
Aurora, Colorado, 80045, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr
Evanston, Illinois, 60201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Hatton Research Institutes
Cincinnati, Ohio, 45220, United States
Sarah Cannon Cancer Center and Research Institute
Nashville, Tennessee, 37203, United States
University of Virgina
Charlottesville, Virginia, 22908, United States
Prince of Wales Hospital; Department of Medical Oncology
Randwick, New South Wales, 2031, Australia
North Shore Private Hospital; Northern Specialist Centre
St Leonards, New South Wales, 2065, Australia
Royal North Shore Hospital; Department of Medical Oncology
St Leonards, New South Wales, 2065, Australia
Princess AleXandra Hospital; Department of Medical Oncology
Woolloongabba, Queensland, 4102, Australia
Calvary North Adelaide; North Adeliade Oncology Centre
North Adelaide, South Australia, 5006, Australia
Royal Melbourne Hospital; Hematology and Medical Oncology
Parkville, Victoria, 3052, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Clin Univ de Bxl Hôpital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, 9000, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
AZ Delta (Campus Wilgenstraat)
Roeselare, 8800, Belgium
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer Agency, Vancouver Clinic; Dept. of Medical Oncology
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba; Neuro-Oncology
Winnipeg, Manitoba, R2H 2A6, Canada
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Cancer Centre of Southeastern Ontario; Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
Ottawa Hospital Regional Cancer Centre; Neuro-Oncology
Ottawa, Ontario, K1H 1C4, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727
Toronto, Ontario, M5G 2M9, Canada
Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
McGill University; Montreal Neurological Institute; Oncology
Montreal, Quebec, H3A 2B4, Canada
Chuq - Hopital Hotel Dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, S7N 4H4, Canada
Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
Aalborg, 9000, Denmark
Righospitalet, Hæmatologisk Klinik
København Ø, 2100, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense, 5000, Denmark
Hopital Avicenne; Rhumatologie
Bobigny, 93009, France
Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
Bordeaux, 33075, France
Institut Bergonie; Gastro Enterologie Oncologie
Bordeaux, 33076, France
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, 69677, France
Centre Jean Perrin; Hopital De Jour
Clermont-Ferrand, 63011, France
Hopital Beaujon; Oncologie
Clichy, 92118, France
Centre Georges François Leclerc
Dijon, 21000, France
Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage
Marseille, 13385, France
Centre Val Aurelle Paul Lamarque; Medecine B3
Montpellier, 34298, France
Hôpital Central; Departement de Neuro-Oncologie
Nancy, 54000, France
Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin
Paris, 75651, France
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurochirurgie
Dresden, 01307, Germany
Justus-Liebig-Universität Giessen; Neurochirurgische Klinik
Giessen, 35392, Germany
Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie
Hamburg, 20246, Germany
Universitatsklinikum Heidelberg; Abteilung Neuroonkologie
Heidelberg, 69120, Germany
Ärztehaus Velen
Ibbenbühren, 49479, Germany
Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie
Mainz, 55131, Germany
Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie
München, 81377, Germany
Univ General Hosp Heraklion; Medical Oncology
Heraklion, 711 10, Greece
University Hospital of Larissa; Oncology
Larissa, 41 110, Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, 546 29, Greece
Dr Stephen Yau; Clinical oncology
Hong Kong, Hong Kong
Hong Kong Sanatorium & Hospital; Comprehensive Oncology Centre
Hong Kong, Hong Kong
Queen Mary Hospital; Microbiology Dept.
Hong Kong, Hong Kong
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, H-1134, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház; Neurosurgery
Miskolc, 3526, Hungary
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
Pécs, 7623, Hungary
Rambam Medical Center; Oncology
Haifa, 3525408, Israel
Hadassah Hebrew University Hospital; Leslie and Michael Gaffin Center for Neuro-Oncology
Jerusalem, 91120, Israel
Rabin MC; Davidof Center - Oncology Institute
Petah Tikva, 4941492, Israel
Chaim Sheba MC; Pediatric Hematology Oncology
Tel Litwinsky, 52621, Israel
Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
Bologna, Emilia-Romagna, 40139, Italy
Ospedale Bufalini
Forlì, Emilia-Romagna, 47023, Italy
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
Milan, Lombardy, 20133, Italy
Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia
Turin, Piedmont, 10126, Italy
Az. Osp. S. Maria; Dept. Di Oncologia Medica
Terni, Umbria, 05100, Italy
Ospedale di Treviso, Universita di Padova; Neurosurgery Dept
Treviso, Veneto, 31100, Italy
Hiroshima University Hospital; Neurosurgery
Hiroshima, 734-8551, Japan
Tsukuba University Hospital; Neurology
Ibaraki, 305-8576, Japan
Kumamoto University Hospital; Neurosurgery
Kumamoto, 860-8556, Japan
Kitano Hospital; Neurosurgery
Osaka, 530-8480, Japan
Saitama Medical University International Medical Center; Clinical and Medical Oncology
Saitama, 350-1298, Japan
National Cancer Center Hospital; Neurosurgery
Tokyo, 104-0045, Japan
Komagome Hospital; Neurosurgery
Tokyo, 113-8677, Japan
Kyorin University Hospital; Neurosurgery
Tokyo, 181-8611, Japan
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam, 1081 HV, Netherlands
Catharina Ziekenhuis; Dept of Internal Medicin
Eindhoven, 5623 EJ, Netherlands
Utrecht University Medical Centre; Dept of Medical Oncology and UPC
Utrecht, 3584 CW, Netherlands
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, 1023, New Zealand
Christchurch Hospital; Dept of Oncology
Christchurch, New Zealand
Waikato Hospital; Regional Cancer Center
Hamilton, New Zealand
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
Bialystok, 15-027, Poland
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, 85-796, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi
Lublin, 20-954, Poland
IPO de Coimbra; Servico de Oncologia Medica
Coimbra, 3000-075, Portugal
IPO de Lisboa; Servico de Neurologia
Lisbon, 1099-023, Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, 1649-035, Portugal
Hospital de Sao Joao; Servico de Oncologia
Porto, 4200-319, Portugal
Institut Oncologic Prof. Dr. Alexandru Trestioreanu; Departament Radioterapie
Bucharest, 022328, Romania
Institut Oncologic Ion Chiricuta; Departament Radioterapie
Cluj-Napoca, 400015, Romania
Spital Clinic Judetean Mures; Oncologie
Târgu Mureş, 540142, Romania
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow, 105229, Russia
Russian Research Oncology Center n.a. N.N. Blokhin of the RAMS; Department of Neurosurgery
Moscow, 115478, Russia
Scientific Research Neurosurgery Institute; Dept. of Neurooncology
Moscow, 125047, Russia
Institution of Higher Professional Learning Military; Neurooncology
Saint Petersburg, 194175, Russia
Pusan National University Hospital; Neuro Sugery
Busan, 602-739, South Korea
Kyungpook National University Hosital; Neuro Sugery
Daegu, 700-721, South Korea
National Cancer Centre; Neurosurgery Dept
Goyang-si, 410-769, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, 03080, South Korea
Asan Medical Center; Medical Oncology
Seoul, 05505, South Korea
Yonsei University Severance Hospital; Medical Oncology
Seoul, 120-752, South Korea
Samsung Medical Center; Neurosurgery Department
Seoul, 135-170, South Korea
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036, Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, 08916, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, 29010, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010, Spain
Sahlgrenska Universitetssjukhuset; Jubileumskliniken
Gothenburg, 413 45, Sweden
Skånes University Hospital, Skånes Department of Onclology
Lund, 22185, Sweden
Norrlands Universitetssjukhus; Cancer Centrum
Umeå, 901 85, Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, 75185, Sweden
HUG; Oncologie
Geneva, 1211, Switzerland
Queen Elizabeth Medical Centre; Neurosurgery
Birmingham, B15 2TT, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
The Royal Marsden NHS Foundation Trust; Oncology
London, SW3 6JJ, United Kingdom
The Clatterbridge Cancer Ctr For Oncolgy
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Northern Centre for Cancer Care;Oncology
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham City Hospital; Dept of Haematology
Nottingham, NG5 1PB, United Kingdom
Queen's Hospital; Oncology
Romford, RM7 0AG, United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, S10 2SJ, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, SM2 5PT, United Kingdom
Related Publications (8)
Seliger C, Oppong FB, Lefranc F, Chinot O, Stupp R, Nabors B, Gorlia T, Weller M; EORTC Brain Tumor Group. Association of antidepressant drug use with outcome of patients with glioblastoma. Int J Cancer. 2023 Apr 1;152(7):1348-1359. doi: 10.1002/ijc.34344. Epub 2022 Nov 17.
PMID: 36346112DERIVEDHagiwara A, Schlossman J, Shabani S, Raymond C, Tatekawa H, Abrey LE, Garcia J, Chinot O, Saran F, Nishikawa R, Henriksson R, Mason WP, Wick W, Cloughesy TF, Ellingson BM. Incidence, molecular characteristics, and imaging features of "clinically-defined pseudoprogression" in newly diagnosed glioblastoma treated with chemoradiation. J Neurooncol. 2022 Sep;159(3):509-518. doi: 10.1007/s11060-022-04088-3. Epub 2022 Jul 17.
PMID: 35842871DERIVEDJiguet-Jiglaire C, Boissonneau S, Denicolai E, Hein V, Lasseur R, Garcia J, Romain S, Appay R, Graillon T, Mason W, Carpentier AF, Brandes AA, Ouafik L', Wick W, Baaziz A, Gigan JP, Arguello RJ, Figarella-Branger D, Chinot O, Tabouret E. Plasmatic MMP9 released from tumor-infiltrating neutrophils is predictive for bevacizumab efficacy in glioblastoma patients: an AVAglio ancillary study. Acta Neuropathol Commun. 2022 Jan 3;10(1):1. doi: 10.1186/s40478-021-01305-4.
PMID: 34980260DERIVEDChinot OL, Nishikawa R, Mason W, Henriksson R, Saran F, Cloughesy T, Garcia J, Revil C, Abrey L, Wick W. Upfront bevacizumab may extend survival for glioblastoma patients who do not receive second-line therapy: an exploratory analysis of AVAglio. Neuro Oncol. 2016 Sep;18(9):1313-8. doi: 10.1093/neuonc/now046. Epub 2016 Mar 22.
PMID: 27006178DERIVEDSaran F, Chinot OL, Henriksson R, Mason W, Wick W, Cloughesy T, Dhar S, Pozzi E, Garcia J, Nishikawa R. Bevacizumab, temozolomide, and radiotherapy for newly diagnosed glioblastoma: comprehensive safety results during and after first-line therapy. Neuro Oncol. 2016 Jul;18(7):991-1001. doi: 10.1093/neuonc/nov300. Epub 2016 Jan 24.
PMID: 26809751DERIVEDTaphoorn MJ, Henriksson R, Bottomley A, Cloughesy T, Wick W, Mason WP, Saran F, Nishikawa R, Hilton M, Theodore-Oklota C, Ravelo A, Chinot OL. Health-Related Quality of Life in a Randomized Phase III Study of Bevacizumab, Temozolomide, and Radiotherapy in Newly Diagnosed Glioblastoma. J Clin Oncol. 2015 Jul 1;33(19):2166-75. doi: 10.1200/JCO.2014.60.3217. Epub 2015 May 26.
PMID: 26014298DERIVEDChinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.
PMID: 24552318DERIVEDChinot OL, Macdonald DR, Abrey LE, Zahlmann G, Kerloeguen Y, Cloughesy TF. Response assessment criteria for glioblastoma: practical adaptation and implementation in clinical trials of antiangiogenic therapy. Curr Neurol Neurosci Rep. 2013 May;13(5):347. doi: 10.1007/s11910-013-0347-2.
PMID: 23529375DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2009
First Posted
July 22, 2009
Study Start
June 29, 2009
Primary Completion
February 28, 2013
Study Completion
September 9, 2015
Last Updated
September 25, 2017
Results First Posted
May 20, 2013
Record last verified: 2017-08