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GlioblastomaPhase 2NCT01860638

A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With Glioblastoma

A Phase 2 study testing Bevacizumab, Lomustine and Radiotherapy in people with Glioblastoma, run by Hoffmann-La Roche at 64 sites in 15 countries.

Completed

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

Official record
Search all trials

Trial summary

This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line [2L] treatment) and SOC (in 3rd-line [3L] and subsequent lines of treatment) following first-line disease progression (PD1) in participants with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Bevacizumab, Lomustine and Radiotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
296 participants
Where
64 sitesin 15 countries
Study dates
19 Aug 2013to 5 May 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

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

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed, histologically confirmed glioblastoma not previously treated with chemotherapy or radiotherapy
  • If female and not postmenopausal (less than [<] 12 months of amenorrhea) or surgically sterile, must agree to use a highly effective contraceptive method during the treatment period and for at least 6 months after the last dose of study drug
  • Karnofsky performance status (KPS) greater than or equal to (>/=) 60
  • Mandatory tissue collection during pre-study surgery or biopsy for confirmation of the diagnosis and pathology
  • Craniotomy or intracranial biopsy site must be adequately healed. Study treatment should be initiated > 28 days following the last surgical procedure
  • Documented PD1 according to RANO criteria
Show all 12Show fewer
  • Eligibility for second-line treatment with lomustine and bevacizumab as investigational medicinal products
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Bevacizumab well tolerated and not interrupted for longer than 60 days during first-line treatment
  • Tissue submission among participants for whom operation/re-operation is indicated before second-line treatment starts; operation/re-operation performed >/=28 days after last bevacizumab administration and second-line treatment initiated >/=28 days after surgical wound healed
  • Randomization within 28 days after PD1 among participants for whom operation/re-operation is not necessary
  • First administration of second-line treatment no later than 2 days from randomization

Who cannot join

  • Any prior chemotherapy for glioblastoma and low-grade astrocytomas
  • Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field
  • Prior or current anti-angiogenic treatment
  • Treatment with any other investigational drug within 28 days or 2 investigational agent half-lives (whichever is longer) prior to first study treatment
  • Inadequate hematological, renal, or liver function
  • Inadequately controlled hypertension
Show all 16Show fewer
  • Prior history of gastrointestinal perforation or abscess
  • Clinically significant cardiovascular disease
  • History or evidence of central nervous system disease unrelated to cancer unless adequately treated with standard medical therapy
  • History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding
  • Serious non-healing wound, active ulcer, or untreated bone fracture
  • Known hypersensitivity to any component of bevacizumab/placebo or any of the study drugs
  • Active infection requiring IV antibiotics at start of study treatment
  • Other malignancy within 5 years prior to study enrollment, except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ treated with curative intent
  • Pregnant or lactating women
  • Participation in any other study

Trial locations and contacts

64 sites in 15 countries.

64 sites in 15 countries

Spain15 sites

  • Hospital Universitario Infanta Cristina; Servicio de Oncologia

    Badajoz, 06080

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Hospital del Mar; Servicio de Oncologia

    Barcelona, 08003

  • Hospital Duran i Reynals; Oncologia

    Barcelona, 08907

  • Hospital de Cruces; Servicio de Oncologia

    Bilbao, Vizcaya, 48903

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

    Madrid, 28050

  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

    Málaga, 29010

  • Hospital Universitario Son Espases; Servicio de Oncologia

    Palma de Mallorca, Balearic Islands, 07014

  • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

    Salamanca, 37007

Other trials in Spain

France11 sites

  • HOPITAL JEAN MINJOZ; Oncologie

    Besançon, 25030

  • Hopital Avicenne; Neurologie

    Bobigny, 93009

  • Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale

    Bordeaux, 33075

  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

    Bron, 69677

  • Hopital Cote De Nacre; Unite Neurologie Generale

    Caen, 14033

  • Centre Georges Francois Leclerc; Oncologie 3

    Dijon, 21079

  • Hopital Roger Salengro; Service de Neurologie

    Lille, 59037

  • Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

    Marseille, 13385

  • Hôpital Central; Departement de Neuro-Oncologie

    Nancy, 54000

  • Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

    Paris, 75651

  • Hopital Purpan

    Toulouse, 31059

Other trials in France

Austria6 sites

  • Medizinische Universität Graz; Universitätsklinik für Neurologie

    Graz, 8036

  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

    Innsbruck, 6020

  • Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie

    Linz, 4020

  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

    Salzburg, 5020

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

    Vienna, 1090

  • Kaiser-Franz-Josef-Spital; Neurologische Abteilung

    Vienna, 1100

Other trials in Austria

Italy5 sites

  • Ospedale Bellaria; U.O. Oncologia Medica

    Bologna, Emilia-Romagna, 40133

  • Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

    Milan, Lombardy, 20133

  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

    Padova, Veneto, 35128

  • IFO - Istituto Regina Elena; Oncologia Medica

    Rome, Lazio, 00144

  • Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

    Turin, Piedmont, 10126

Other trials in Italy

United Kingdom5 sites

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Addenbrookes Hospital; Dept of Oncology

    Cambridge, CB2 2QQ

  • University College Hospital; Department of Oncology

    London, N7 9NH

  • Christie Hospital Nhs Trust; Medical Oncology

    Manchester, M2O 4BX

  • Royal Marsden Hospital; Dept of Medical Oncology

    Sutton, SM2 5PT

Other trials in United Kingdom

Turkey (Türkiye)4 sites

  • Adana City Hospital, Medical Oncology

    Adana, 01060

  • Baskent Universitesi Tıp Fakultesi; Ic Hastalıkları Anabilim Dalı Tıbbi Onkoloji Bilim Dalı

    Ankara, 06490

  • Dokuz Eylul Uni ; Medical Oncology

    Izmir, 35340

  • Kocaeli University Faculty of Medicine; Medical oncology

    İzmit, 31380

Other trials in Turkey (Türkiye)

Greece3 sites

  • Agioi Anargyroi Anticancer Hospital; Radiotherapeutic Clinic

    Kifissia, 14564

  • Hygeia Hospital

    Marousi, 15123

  • Papageorgiou General Hospital; Medical Oncology

    Thessaloniki, 546 29

Other trials in Greece

Portugal3 sites

  • IPO de Coimbra; Servico de Oncologia Medica

    Coimbra, 3000-075

  • Hospital de Santa Maria; Servico de Oncologia Medica

    Lisbon, 1649-035

  • Hospital de Sao Joao; Servico de Oncologia

    Porto, 4200-319

Other trials in Portugal

Romania3 sites

  • Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

    Bucharest, 022328

  • Institut Oncologic Ion Chiricuta; Departament Radioterapie

    Cluj-Napoca, 400015

  • Spital Clinic Judetean Mures; Oncologie

    Târgu Mureş, 540142

Other trials in Romania

Sweden3 sites

  • Universitetssjukhuset; Onkologkliniken

    Linköping, 58185

  • Norrlands Universitetssjukhus; Cancer Centrum

    Umeå, 901 85

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 75185

Other trials in Sweden

Canada2 sites

  • Tom Baker Cancer Centre; Dept of Medicine

    Calgary, Alberta, T2N 4N2

  • McGill University; Montreal Neurological Institute; Oncology

    Montreal, Quebec, H3A 2B4

Other trials in Canada

Bulgaria1 site

  • MBAL Serdika EOOD

    Sofia, 1303

Other trials in Bulgaria

Croatia1 site

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Estonia1 site

  • Tartu University Hospital; Clinic of Hematology and Oncology

    Tartu, 50406

Other trials in Estonia

Latvia1 site

  • Riga East Clinical University hospital, Clinic Gailezers, Dept of Neurosurgery

    Riga, LV-1038

Other trials in Latvia

About this study

Official title: A Double-Blind, Placebo-Controlled, Randomised, Phase II Study Evaluating the Efficacy and Safety of Addition of Continuous Multiple Line Bevacizumab Treatment to Lomustine in Second (2nd)-Line Followed by Standard of Care (SOC) in Third (3rd)-Line and Beyond Compared to Addition of Placebo, Following First Progression of Disease (PD1) in Patients With Glioblastoma (GBM) After First (1st)-Line Treatment With Radiotherapy, Temozolomide and Bevacizumab

This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line [2L] treatment) and SOC (in 3rd-line [3L] and subsequent lines of treatment) following first-line disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or placebo with the addition of an SOC agent. Following third-line disease progression (PD3), participants will receive subsequent lines of treatment and will either continue blinded bevacizumab or placebo (at the discretion of the investigator), or switch to open-label bevacizumab (at the choice of the participant).

Conditions
Glioblastoma
Being tested
Bevacizumab, Lomustine, Placebo, Radiotherapy, Temozolomide
Medical subject headings
Glioblastoma

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab will be administered at a dose of 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks (Q2W) throughout the study, with the exception of bevacizumab monotherapy prior to PD1, which will be given as 15 mg/kg IV every 3 weeks (Q3W).

  • LomustineDrug

    Lomustine will be administered at a dose of 90 milligrams per square meter (mg/m^2) orally (PO) every 6 weeks (Q6W), with a cap of 160 milligrams (mg) per dose. In the absence of hematologic toxicity following the first dose, the second and subsequent doses may be increased to 110 mg/m^2 PO Q6W, with a cap of 200 mg per dose.

  • PlaceboDrug

    Placebo will be administered via IV infusion, in a formulation matched to bevacizumab, Q2W after randomization.

  • RadiotherapyRadiation

    Radiotherapy will be administered for a total dose of 60 Gray (Gy), administered in 2-Gy fractions, 5 days per week for 6 weeks during first-line treatment.

  • TemozolomideDrug

    Temozolomide will be administered orally (PO) as 75 mg/m^2 per day for the first 6 weeks of first-line treatment (concurrent treatment), followed by 6 cycles (28 days each) as follows: 150 mg/m^2 per day for the first 5 days of Cycle 1, then 200 mg/m^2 per day (if permitted by the participant's hematological and non-hematological toxicity profile) for the first 5 days of Cycles 2-6.

  • SOC AgentDrug

    The choice of SOC agent will be at the discretion of investigator. The SOC agent will be administered during third-line treatment and subsequent lines, as per standard practice.

Study groups in NCT01860638
Study groupRoleWhat they receive
First-Line Bevacizumab followed by Bevacizumab + Lomustine/SOCExperimentalParticipants will receive first-line treatment with radiotherapy, temozolomide, and bevacizumab. All three treatments will be given concurrently for the first 6 weeks, followed by 6 cycles (28 days each) of temozolomide plus bevacizumab, followed by bevacizumab monotherapy until PD1 or unacceptable toxicity. At PD1, participants randomized to bevacizumab will receive bevacizumab plus lomustine until PD2. Following PD2, participants will continue with blinded bevacizumab with the addition of appropriate SOC. Following PD3, for subsequent treatment lines blinded bevacizumab may continue or open-label bevacizumab may be given at the discretion of the investigator and the participant.
Receives: Drug: Bevacizumab; Drug: Lomustine; Radiation: Radiotherapy; Drug: Temozolomide; Drug: SOC Agent
First-Line Bevacizumab followed by Placebo + Lomustine/SOCPlacebo comparatorParticipants will receive first-line treatment with radiotherapy, temozolomide, and bevacizumab. All three treatments will be given concurrently for the first 6 weeks, followed by 6 cycles (28 days each) of temozolomide plus bevacizumab, followed by bevacizumab monotherapy until PD1 or unacceptable toxicity. At PD1, participants randomized to placebo will receive placebo plus lomustine until PD2. Following PD2, participants will continue with blinded placebo with the addition of appropriate SOC. Following PD3, for subsequent treatment lines blinded bevacizumab may continue or open-label bevacizumab may be given at the discretion of the investigator and the participant.
Receives: Drug: Bevacizumab; Drug: Lomustine; Drug: Placebo; Radiation: Radiotherapy; Drug: Temozolomide; Drug: SOC Agent

What is being measured

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

  1. Overall Survival (OS)

    Measured: From randomization at PD1 until death from any cause or end of study (overall approximately 35 months)

Secondary outcomes (25)

  1. Percentage of Participants Alive at 6, 12, and 18 Months from Randomization

    Measured: At 6, 12, and 18 months after randomization/PD1 (overall up to approximately 35 months)

  2. Progression-Free Survival (PFS) on 2L Treatment According to Modified Response Assessment in Neuro-Oncology (RANO) Criteria

    Measured: From first administration of randomized treatment until PD2 or death from any cause (overall approximately 18 months)

  3. PFS on 3L Treatment According to Modified RANO Criteria

    Measured: From first administration of randomized treatment until PD3 or death from any cause (overall approximately 35 months)

  4. Restricted PFS on 3L Treatment According to Modified RANO Criteria

    Measured: From first administration of treatment after PD2 until PD3 or death from any cause (overall approximately 26 months)

  5. Percentage of Participants with 2L Objective Response of Complete Response (CR) or Partial Response (PR) According to Modified RANO Criteria

    Measured: From randomization/PD1 until PD2, death, subsequent anticancer therapy, operation/re-operation for glioblastoma, or 13 weeks after last administration of 2L-treatment, whichever occurs first (approximately 18 months overall)

  6. Percentage of Participants with 3L Objective Response of CR or PR According to Modified RANO Criteria

    Measured: From PD2 until PD3, death, subsequent anticancer therapy, operation/re-operation for glioblastoma, or 13 weeks after last administration of study treatment, whichever occurs first (approximately 26 months overall)

  7. Percentage of Participants with 2L Disease Control as CR, PR, or Stable Disease According to Modified RANO Criteria

    Measured: From randomization/PD1 until PD2, death, subsequent anticancer therapy, operation/re-operation for glioblastoma, or 13 weeks after last administration of 2L-treatment, whichever occurs first (approximately 18 months overall)

  8. Percentage of Participants with 3L Disease Control as CR, PR, or SD According to Modified RANO Criteria

    Measured: From PD2/start of 3L-treatment until PD3, death, subsequent anticancer therapy, operation/re-operation for glioblastoma, or 13 weeks after last administration of 3L-treatment, whichever occurs first (approximately 26 months overall)

  9. Duration of 2L Objective Response Assessed According to Modified RANO Criteria

    Measured: From first occurrence of CR/PR after randomization/PD1 until PD2, death from any cause, subsequent anticancer therapy, whichever occurs first (approximately 18 months overall)

  10. Duration of 3L Objective Response According to Modified RANO Criteria

    Measured: From first occurrence of CR/PR after PD2 until PD3, subsequent anticancer therapy, or death from any cause, whichever occurs first (approximately 26 months overall)

  11. Percentage of Participants with Adverse Events (AEs)

    Measured: From baseline up to 30 days after last dose (up to 41 months overall)

  12. 1L Treatment: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) Global Health Status/Global QoL Scale Score

    Measured: Baseline;Week(Wk)3,5;end of Wk6;Maintenance:Day(D)1 (Visit[V]1), D15 (V2) Cycles(C)1-6 Q4W;Monotherapy:V1-V44 Q3W;Safety Follow-up(FU) (30 days after last 1L dose);PD FUs(8 Wk after Safety FU [PD FU1],then every 12 Wk until PD1) (up to 41 months overall)

  13. 2L and 3L Treatment: Change From 2L Baseline in EORTC QLQ C30 Global Health Status/Global QoL Scale Score

    Measured: 2L Baseline (2L treatment V1); 2L treatment: V2-V41 (Q2W) until PD2; 3L treatment: V1-V61 (Q2W) until PD3; Safety FU (30 days after last 3L dose); PD FU1 (8 Wk after Safety FU); end of study (up to 41 months overall)

  14. 1L Treatment: Change From Baseline in EORTC QLQ Brain Cancer Module 20 (BN20) Multiple Item Score

    Measured: Baseline; Wk 3, 5; end of Wk6; Maintenance: D1(V1), D15(V2) of C1-6 (Q4W); Monotherapy: V1-V44 (Q3W); Safety FU (30 days after last 1L dose); PD FUs (8 Wk after Safety FU [PD FU1], then every 12 Wk until PD1) (up to 41 months overall)

  15. 2L and 3L Treatment: Change From 2L Baseline in EORTC QLQ BN20 Multiple Item Score

    Measured: 2L Baseline (2L treatment V1); 2L treatment: V2-V41 (Q2W) until PD2; 3L treatment: V1-V61 (Q2W) until PD3; Safety FU (30 days after last 3L dose); PD FU1 (8 Wk after Safety FU); end of study (up to 41 months overall)

  16. Percentage of Participants with Mini Mental Status Examination (MMSE) Score <27 or >/=27

    Measured: Baseline and 2L Baseline

  17. 1L Treatment: Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) z-score

    Measured: Baseline; Maintenance: D1(V1) Cycles 1, 3, 5 (Q4W); Monotherapy: every 3rd visit starting from V1 to V43 (Q3W); Safety FU (30 days after last 1L dose); PD FUs (8 Wk after Safety FU [PD FU1], then every 12 Wk until PD1) (up to 41 months overall)

  18. 2L and 3L Treatment: Change From 2L Baseline in HVLT-R z-score

    Measured: 2L Baseline; 2L treatment: every 6th visit starting from V7 to V43 (Q2W); 3L treatment: every 6th visit starting from V1 to V37, V49, V61 (Q2W); Safety FU (30 days after last 3L dose); PD FU1 (8 Wk after Safety FU); end of study (up to 41 months overall)

  19. 1L Treatment: Change From Baseline in Controlled Oral Word Association (COWA) z-score

    Measured: Baseline; Maintenance: D1(V1) Cycles 1, 3, 5 (Q4W); Monotherapy: every 3rd visit starting from V1 to V43 (Q3W); Safety FU (30 days after last 1L dose); PD FUs (8 Wk after Safety FU [PD FU1], then every 12 Wk until PD1) (up to 41 months overall)

  20. 2L and 3L Treatment: Change From 2L Baseline in COWA z-score

    Measured: 2L Baseline; 2L treatment: every 6th visit starting from V7 to V43 (Q2W); 3L treatment: every 6th visit starting from V1 to V37, V49, V61 (Q2W); Safety FU (30 days after last 3L dose); PD FU1 (8 Wk after Safety FU); end of study (up to 41 months overall)

  21. 1L Treatment: Change From Baseline in Trail-Making Test (TMT) Part A and B z-score

    Measured: Baseline; Maintenance: D1(V1) Cycles 1, 3, 5 (Q4W); Monotherapy: every 3rd visit starting from V1 to V43 (Q3W); Safety FU (30 days after last 1L dose); PD FUs (8 Wk after Safety FU [PD FU1], then every 12 Wk until PD1) (up to 41 months overall)

  22. 2L and 3L Treatment: Change From 2L Baseline in TMT Part A and Part B z-score

    Measured: 2L Baseline; 2L treatment: every 6th visit starting from V7 to V43 (Q2W); 3L treatment: every 6th visit starting from V1 to V37, V49, V61 (Q2W); Safety FU (30 days after last 3L dose); PD FU1 (8 Wk after Safety FU); end of study (up to 41 months overall)

  23. Number of Participants with Hospitalizations According to Type of Hospitalizations

    Measured: From Baseline up to death or study withdrawal/study end (up to 41 months overall)

  24. Duration of Hospitalizations According to Type of Hospitalizations

    Measured: From Baseline up to death or study withdrawal/study end (up to 41 months overall)

  25. EuroQol Five-Dimension Questionnaire (EQ-5D) Score

    Measured: From Baseline up to death or study withdrawal/study end (up to 41 months overall)

Timeline

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

  1. First posted23 May 2013 (estimated)
  2. Study start19 Aug 2013
  3. Primary completion13 Jan 2017
  4. Study completion5 May 2017

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01860638
Sponsor's protocol ID
MO28347
Other IDs
2012-003138-17
Status last verified
Apr 2018
First submitted
21 May 2013
Last updated
30 Apr 2018
Results posted
No

Publications

  • Brandes AA, Gil-Gil M, Saran F, Carpentier AF, Nowak AK, Mason W, Zagonel V, Dubois F, Finocchiaro G, Fountzilas G, Cernea DM, Chinot O, Anghel R, Ghiringhelli F, Beauchesne P, Lombardi G, Franceschi E, Makrutzki M, Mpofu C, Urban HJ, Pichler J. A Randomized Phase II Trial (TAMIGA) Evaluating the Efficacy and Safety of Continuous Bevacizumab Through Multiple Lines of Treatment for Recurrent Glioblastoma. Oncologist. 2019 Apr;24(4):521-528. doi: 10.1634/theoncologist.2018-0290. Epub 2018 Sep 28.

    PubMed 30266892

  • Brandes AA, Mason W, Pichler J, Nowak AK, Gil M, Saran F, Revil C, Lutiger B, Carpentier AF. Can bevacizumab prolong survival for glioblastoma patients through multiple lines of therapy? Future Oncol. 2014 May;10(7):1137-45. doi: 10.2217/fon.14.75.

    PubMed 24947255

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Lomustine and Radiotherapy in people with Glioblastoma, run by Hoffmann-La Roche at 64 sites in 15 countries.

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

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Spain, France, Austria, Italy, United Kingdom and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

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

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

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

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization at PD1 until death from any cause or end of study (overall approximately 35 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01860638, which also lists 2 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.

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