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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

Primary Purpose

Glioblastoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Bevacizumab

Lomustine

Placebo

Radiotherapy

Temozolomide

SOC Agent

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria at Enrollment (before PD1):

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

Inclusion Criteria at Randomization (following PD1):

Documented PD1 according to RANO criteria
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

Exclusion Criteria at Enrollment (before PD1):

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
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

Sites / Locations

Medizinische Universität Graz; Universitätsklinik für Neurologie
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Kaiser-Franz-Josef-Spital; Neurologische Abteilung
MBAL Serdika EOOD
Tom Baker Cancer Centre; Dept of Medicine
McGill University; Montreal Neurological Institute; Oncology
Clinical Hospital Centre Zagreb
Tartu University Hospital; Clinic of Hematology and Oncology
HOPITAL JEAN MINJOZ; Oncologie
Hopital Avicenne; Neurologie
Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Hopital Cote De Nacre; Unite Neurologie Generale
Centre Georges Francois Leclerc; Oncologie 3
Hopital Roger Salengro; Service de Neurologie
Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage
Hôpital Central; Departement de Neuro-Oncologie
Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin
Hopital Purpan
Agioi Anargyroi Anticancer Hospital; Radiotherapeutic Clinic
Hygeia Hospital
Papageorgiou General Hospital; Medical Oncology
Ospedale Bellaria; U.O. Oncologia Medica
IFO - Istituto Regina Elena; Oncologia Medica
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Riga East Clinical University hospital, Clinic Gailezers, Dept of Neurosurgery
IPO de Coimbra; Servico de Oncologia Medica
Hospital de Santa Maria; Servico de Oncologia Medica
Hospital de Sao Joao; Servico de Oncologia
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
Institut Oncologic Ion Chiricuta; Departament Radioterapie
Spital Clinic Judetean Mures; Oncologie
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Hospital Universitario Reina Sofia; Servicio de Oncologia
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
Hospital Universitario Son Espases; Servicio de Oncologia
Hospital de Cruces; Servicio de Oncologia
Hospital Universitario Infanta Cristina; Servicio de Oncologia
Hospital del Mar; Servicio de Oncologia
Hospital Duran i Reynals; Oncologia
Hospital Ramon y Cajal; Servicio de Oncologia
Hosp. Clinico San Carlos
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Hospital Universitario La Paz; Servicio de Oncologia
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Universitetssjukhuset; Onkologkliniken
Norrlands Universitetssjukhus; Cancer Centrum
Akademiska sjukhuset, Onkologkliniken
Adana City Hospital, Medical Oncology
Baskent Universitesi Tıp Fakultesi; Ic Hastalıkları Anabilim Dalı Tıbbi Onkoloji Bilim Dalı
Dokuz Eylul Uni ; Medical Oncology
Kocaeli University Faculty of Medicine; Medical oncology
Bristol Haematology and Oncology Centre
Addenbrookes Hospital; Dept of Oncology
University College Hospital; Department of Oncology
Christie Hospital Nhs Trust; Medical Oncology
Royal Marsden Hospital; Dept of Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

First-Line Bevacizumab followed by Bevacizumab + Lomustine/SOC

First-Line Bevacizumab followed by Placebo + Lomustine/SOC

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

Overall Survival (OS)

Secondary Outcome Measures

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

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

PFS on 3L Treatment According to Modified RANO Criteria

Restricted PFS on 3L Treatment According to Modified RANO Criteria

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

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

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

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

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

Duration of 3L Objective Response According to Modified RANO Criteria

Percentage of Participants with Adverse Events (AEs)

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

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

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

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

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

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

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

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

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

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

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

Number of Participants with Hospitalizations According to Type of Hospitalizations

Duration of Hospitalizations According to Type of Hospitalizations

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

Full Information

NCT ID

NCT01860638

First Posted

May 21, 2013

Last Updated

April 26, 2018

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01860638

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

August 19, 2013 (Actual)

Primary Completion Date

January 13, 2017 (Actual)

Study Completion Date

May 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

296 (Actual)

8. Arms, Groups, and Interventions

Arm Title

First-Line Bevacizumab followed by Bevacizumab + Lomustine/SOC

Arm Type

Experimental

Arm Description

Arm Title

First-Line Bevacizumab followed by Placebo + Lomustine/SOC

Arm Type

Placebo Comparator

Arm Description

Participants 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.

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Lomustine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

SOC Agent

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame

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

Title

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

Time Frame

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

Title

PFS on 3L Treatment According to Modified RANO Criteria

Time Frame

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

Title

Restricted PFS on 3L Treatment According to Modified RANO Criteria

Time Frame

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

Title

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

Time Frame

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)

Title

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

Time Frame

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)

Title

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

Time Frame

Title

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

Time Frame

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)

Title

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

Time Frame

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)

Title

Duration of 3L Objective Response According to Modified RANO Criteria

Time Frame

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)

Title

Percentage of Participants with Adverse Events (AEs)

Time Frame

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

Title

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

Time Frame

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)

Title

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

Time Frame

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)

Title

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

Time Frame

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)

Title

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

Time Frame

Title

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

Time Frame

Baseline and 2L Baseline

Title

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

Time Frame

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)

Title

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

Time Frame

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)

Title

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

Time Frame

Title

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

Time Frame

Title

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

Time Frame

Title

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

Time Frame

Title

Number of Participants with Hospitalizations According to Type of Hospitalizations

Time Frame

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

Title

Duration of Hospitalizations According to Type of Hospitalizations

Time Frame

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

Title

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria at Enrollment (before PD1): 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 Inclusion Criteria at Randomization (following PD1): Documented PD1 according to RANO criteria 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 Exclusion Criteria at Enrollment (before PD1): 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Medizinische Universität Graz; Universitätsklinik für Neurologie

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

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

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

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

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Kaiser-Franz-Josef-Spital; Neurologische Abteilung

City

Wien

ZIP/Postal Code

1100

Country

Austria

Facility Name

MBAL Serdika EOOD

City

Sofia

ZIP/Postal Code

1303

Country

Bulgaria

Facility Name

Tom Baker Cancer Centre; Dept of Medicine

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

McGill University; Montreal Neurological Institute; Oncology

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

Clinical Hospital Centre Zagreb

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Tartu University Hospital; Clinic of Hematology and Oncology

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

HOPITAL JEAN MINJOZ; Oncologie

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

Hopital Avicenne; Neurologie

City

Bobigny

ZIP/Postal Code

93009

Country

France

Facility Name

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

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

City

Bron

ZIP/Postal Code

69677

Country

France

Facility Name

Hopital Cote De Nacre; Unite Neurologie Generale

City

Caen

ZIP/Postal Code

14033

Country

France

Facility Name

Centre Georges Francois Leclerc; Oncologie 3

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

Hopital Roger Salengro; Service de Neurologie

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

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

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Hôpital Central; Departement de Neuro-Oncologie

City

Nancy

ZIP/Postal Code

54000

Country

France

Facility Name

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

City

Paris

ZIP/Postal Code

75651

Country

France

Facility Name

Hopital Purpan

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Agioi Anargyroi Anticancer Hospital; Radiotherapeutic Clinic

City

Kifisia

ZIP/Postal Code

14564

Country

Greece

Facility Name

Hygeia Hospital

City

Marousi

ZIP/Postal Code

15123

Country

Greece

Facility Name

Papageorgiou General Hospital; Medical Oncology

City

Thessaloniki

ZIP/Postal Code

546 29

Country

Greece

Facility Name

Ospedale Bellaria; U.O. Oncologia Medica

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40133

Country

Italy

Facility Name

IFO - Istituto Regina Elena; Oncologia Medica

City

Roma

State/Province

Lazio

ZIP/Postal Code

00144

Country

Italy

Facility Name

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

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

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

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10126

Country

Italy

Facility Name

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Facility Name

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

City

Riga

ZIP/Postal Code

LV-1038

Country

Latvia

Facility Name

IPO de Coimbra; Servico de Oncologia Medica

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Hospital de Santa Maria; Servico de Oncologia Medica

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Hospital de Sao Joao; Servico de Oncologia

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

Institut Oncologic Ion Chiricuta; Departament Radioterapie

City

Cluj-napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Spital Clinic Judetean Mures; Oncologie

City

Targu Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital Universitario Reina Sofia; Servicio de Oncologia

City

Córdoba

State/Province

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

City

San Sebastian

State/Province

Guipuzcoa

ZIP/Postal Code

20014

Country

Spain

Facility Name

Hospital Universitario Son Espases; Servicio de Oncologia

City

Palma De Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07014

Country

Spain

Facility Name

Hospital de Cruces; Servicio de Oncologia

City

Bilbao

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Hospital Universitario Infanta Cristina; Servicio de Oncologia

City

Badajoz

ZIP/Postal Code

06080

Country

Spain

Facility Name

Hospital del Mar; Servicio de Oncologia

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital Duran i Reynals; Oncologia

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Ramon y Cajal; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hosp. Clinico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario La Paz; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

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

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Universitetssjukhuset; Onkologkliniken

City

Linkoeping

ZIP/Postal Code

58185

Country

Sweden

Facility Name

Norrlands Universitetssjukhus; Cancer Centrum

City

Umea

ZIP/Postal Code

901 85

Country

Sweden

Facility Name

Akademiska sjukhuset, Onkologkliniken

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Facility Name

Adana City Hospital, Medical Oncology

City

Adana

ZIP/Postal Code

01060

Country

Turkey

Facility Name

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

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Dokuz Eylul Uni ; Medical Oncology

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Kocaeli University Faculty of Medicine; Medical oncology

City

Izmit

ZIP/Postal Code

31380

Country

Turkey

Facility Name

Bristol Haematology and Oncology Centre

City

Bristol

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Addenbrookes Hospital; Dept of Oncology

City

Cambridge

ZIP/Postal Code

CB2 2QQ

Country

United Kingdom

Facility Name

University College Hospital; Department of Oncology

City

London

ZIP/Postal Code

N7 9NH

Country

United Kingdom

Facility Name

Christie Hospital Nhs Trust; Medical Oncology

City

Manchester

ZIP/Postal Code

M2O 4BX

Country

United Kingdom

Facility Name

Royal Marsden Hospital; Dept of Medical Oncology

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30266892

Citation

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.

Results Reference

derived

PubMed Identifier

24947255

Citation

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.

Results Reference

derived

Learn more about this trial

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

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