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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010390-21 |
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This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in combination with conventional involved field radiotherapy, in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide 75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 10mg/kg iv every 2 weeks |
| |
| irinotecan |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months | Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25 percent (%) increase in size of enhancing tumor or any new tumor on gadolinium contrast agent magnetic resonance imaging (Gd-MRI) scans, or neurologically worse, and steroids stable or increased. Percentage of participants achieving PFS without disease progression or death was reported. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25% increase in size of enhancing tumor or any new tumor on Gd-MRI scans, or neurologically worse, and steroids stable or increased. PFS was estimated using Kaplan-Meier method. | From baseline to the end of the study (up to 4.5 years) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aachen | 52074 | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29121274 | Derived | Schafer N, Proescholdt M, Steinbach JP, Weyerbrock A, Hau P, Grauer O, Goldbrunner R, Friedrich F, Rohde V, Ringel F, Schlegel U, Sabel M, Ronellenfitsch MW, Uhl M, Grau S, Hanel M, Schnell O, Krex D, Vajkoczy P, Tabatabai G, Mack F, Schaub C, Tzaridis T, Niessen M, Kebir S, Leutgeb B, Urbach H, Belka C, Stummer W, Glas M, Herrlinger U. Quality of life in the GLARIUS trial randomizing bevacizumab/irinotecan versus temozolomide in newly diagnosed, MGMT-nonmethylated glioblastoma. Neuro Oncol. 2018 Jun 18;20(7):975-985. doi: 10.1093/neuonc/nox204. | |
| 26976423 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Irinotecan | In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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Not provided
| Drug |
125mg/m2 iv every 2 weeks |
|
| temozolomide | Drug | 75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy |
|
| Overall Survival (OS) | Overall survival was defined as the time from randomization to death from any cause. OS was estimated using Kaplan-Meier method. | From baseline until death (up to 4.5 years) |
| Percentage of Participants Who Discontinued | Discontinuation was defined as the percentage of participants who permanently discontinued treatment in either treatment arm. Percentage of participant with individual discontinuation reason are reported. CNS: central nervous system; CTCAE: Common Terminology Criteria for Adverse Events . Other reason refers to any other reason than the specified ones. | From baseline until death (up to 4.5 years) |
| Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR) | BOR was defined as the best response observed for a participant during assessment. Number of participants who had BOR as CR and number of participants who had BOR as CR or PR were reported. Complete response was defined as disappearance of all enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response was defined as 50% reduction in size of enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved. | 4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6 |
| Percentage of Participants With Response on FLAIR Imaging | FLAIR lesions were determined as "stable", "progressive" or "decreased". FLAIR lesions was determined as "progressive" only if they were not be attributed to causes apart from tumor infiltration (sequelae of radiation therapy, demyelination, ischemia, infection, seizures, or other treatment effects). Percentage of participants are based on ITT population. Dis.=Discontinuation. | At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years) |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30) | The EORTC QLQ-C30 incorporates: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of functioning or a higher score for symptom scale=greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ''baseline'' refers to the time of randomization to the maintenance phase. | Baseline, Post-Baseline (up to Month 30) |
| Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30) | EORTC QLQ-BN20 consisted of 20 items assessing visual disorders, motor dysfunction, communication deficit, various disease symptoms (e.g. headaches and seizures), treatment toxicities (e.g. hair loss) and future uncertainty. All of the 20 items are rated on a 4 point Likert scale from 1=not at all, 2=a little, 3=quite a bit and 4=very much, and were linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. | Baseline, Post-Baseline (up to Month 30) |
| Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30) | The MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language and construct ability. Each area tested had a designated point value, the total score can range from 0 to 30, with a higher score indicating better function. | Baseline, Post-Baseline (up to Month 30) |
| Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30) | KPS is an 11-level score (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100) which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Deterioration in KPS was defined as decrease of 20 or more points in KPS score. | Baseline, Post-Baseline (up to Month 30) |
| Percentage of Participants Who Received Corticosteroid for Glioblastoma | Participants used corticosteroids for the glioblastoma condition. Corticosteroids included dexamethasone, methylprednisone, fortecortin, hydrocortisone, urbason, and prednisolone. | From baseline to Month 6 |
| Time to Treatment Failure | From baseline until end of study (up to 4.5 years) |
| Berlin |
| 13353 |
| Germany |
| Bochum | 44892 | Germany |
| Bonn | 53127 | Germany |
| Chemnitz | 09113 | Germany |
| Cologne | 50937 | Germany |
| Dresden | 01307 | Germany |
| Düsseldorf | 40225 | Germany |
| Erfurt | 99089 | Germany |
| Erlangen | 91054 | Germany |
| Frankfurt am Main | 60528 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Göttingen | 37075 | Germany |
| Idar-Oberstein | 55743 | Germany |
| Kiel | 24105 | Germany |
| Leipzig | 04103 | Germany |
| Mannheim | 68167 | Germany |
| Marburg | 35043 | Germany |
| München | 81377 | Germany |
| München | 81675 | Germany |
| Münster | 48149 | Germany |
| Regensburg | 93053 | Germany |
| Tübingen | 72076 | Germany |
| Ulm | 89081 | Germany |
| Derived |
| Herrlinger U, Schafer N, Steinbach JP, Weyerbrock A, Hau P, Goldbrunner R, Friedrich F, Rohde V, Ringel F, Schlegel U, Sabel M, Ronellenfitsch MW, Uhl M, Maciaczyk J, Grau S, Schnell O, Hanel M, Krex D, Vajkoczy P, Gerlach R, Kortmann RD, Mehdorn M, Tuttenberg J, Mayer-Steinacker R, Fietkau R, Brehmer S, Mack F, Stuplich M, Kebir S, Kohnen R, Dunkl E, Leutgeb B, Proescholdt M, Pietsch T, Urbach H, Belka C, Stummer W, Glas M. Bevacizumab Plus Irinotecan Versus Temozolomide in Newly Diagnosed O6-Methylguanine-DNA Methyltransferase Nonmethylated Glioblastoma: The Randomized GLARIUS Trial. J Clin Oncol. 2016 May 10;34(14):1611-9. doi: 10.1200/JCO.2015.63.4691. Epub 2016 Mar 14. |
| FG001 | Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The randomized (RND) population was defined to include all participants randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Irinotecan | In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant. |
| BG001 | Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months | Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25 percent (%) increase in size of enhancing tumor or any new tumor on gadolinium contrast agent magnetic resonance imaging (Gd-MRI) scans, or neurologically worse, and steroids stable or increased. Percentage of participants achieving PFS without disease progression or death was reported. | Intent-to-treat (ITT) population included participants randomized for whom it cannot be ruled out, that they took study medication at least once and where primary variable was measured at least once under study medication. Data were analyzed according to the treatment randomized (as randomized). | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25% increase in size of enhancing tumor or any new tumor on Gd-MRI scans, or neurologically worse, and steroids stable or increased. PFS was estimated using Kaplan-Meier method. | ITT population. Data were analyzed according to the treatment randomized (as randomized). | Posted | Median | 95% Confidence Interval | Months | From baseline to the end of the study (up to 4.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival was defined as the time from randomization to death from any cause. OS was estimated using Kaplan-Meier method. | ITT population. Data were analyzed according to the treatment randomized (as randomized). | Posted | Median | 95% Confidence Interval | Months | From baseline until death (up to 4.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinued | Discontinuation was defined as the percentage of participants who permanently discontinued treatment in either treatment arm. Percentage of participant with individual discontinuation reason are reported. CNS: central nervous system; CTCAE: Common Terminology Criteria for Adverse Events . Other reason refers to any other reason than the specified ones. | ITT population | Posted | Number | percentage of participants | From baseline until death (up to 4.5 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR) | BOR was defined as the best response observed for a participant during assessment. Number of participants who had BOR as CR and number of participants who had BOR as CR or PR were reported. Complete response was defined as disappearance of all enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response was defined as 50% reduction in size of enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved. | ITT population. Data were analyzed according to the treatment randomized (as randomized). Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable of specified time-point. | Posted | Number | participants | 4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Response on FLAIR Imaging | FLAIR lesions were determined as "stable", "progressive" or "decreased". FLAIR lesions was determined as "progressive" only if they were not be attributed to causes apart from tumor infiltration (sequelae of radiation therapy, demyelination, ischemia, infection, seizures, or other treatment effects). Percentage of participants are based on ITT population. Dis.=Discontinuation. | ITT population. Here, n = participants with at least 1 assessment during specified time-point. | Posted | Number | percentage of participants | At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30) | The EORTC QLQ-C30 incorporates: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of functioning or a higher score for symptom scale=greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ''baseline'' refers to the time of randomization to the maintenance phase. | ITT population. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Post-Baseline (up to Month 30) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30) | EORTC QLQ-BN20 consisted of 20 items assessing visual disorders, motor dysfunction, communication deficit, various disease symptoms (e.g. headaches and seizures), treatment toxicities (e.g. hair loss) and future uncertainty. All of the 20 items are rated on a 4 point Likert scale from 1=not at all, 2=a little, 3=quite a bit and 4=very much, and were linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. | ITT population | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Post-Baseline (up to Month 30) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30) | The MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language and construct ability. Each area tested had a designated point value, the total score can range from 0 to 30, with a higher score indicating better function. | ITT population. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Post-Baseline (up to Month 30) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30) | KPS is an 11-level score (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100) which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Deterioration in KPS was defined as decrease of 20 or more points in KPS score. | ITT population | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Post-Baseline (up to Month 30) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Received Corticosteroid for Glioblastoma | Participants used corticosteroids for the glioblastoma condition. Corticosteroids included dexamethasone, methylprednisone, fortecortin, hydrocortisone, urbason, and prednisolone. | The safety population (SAF) was defined to include all participants who received at least 1 dose of study medication. Data were analyzed according to the treatment actually received (as treated). | Posted | Number | percentage of participants | From baseline to Month 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | Data for this outcome measure were not collected as this outcome was removed as per changes in planned analysis. | Posted | Median | Full Range | years | From baseline until end of study (up to 4.5 years) |
|
4 years, 5 months,24 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab + Irinotecan | In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant. | 86 | 119 | 107 | 119 | ||
| EG001 | Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator or and, if eligible. | 46 | 55 | 37 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Restrictive cardiomyopathy | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bone abscess | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| extradural abscess | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cerebral cys | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Complex partial seizures | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Intracranial haematoma | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Neurological decompensation | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Postictal paralysis | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Subdural hygroma | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Panic attack | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Cystitis glandularis | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Pulmonary fistula | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Therapeutic procedure | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Embolism | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
Data for time to treatment failure were not collected as this outcome was removed as per changes in planned analysis.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077146 | Irinotecan |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
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| OG001 | Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible. |
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In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
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| OG001 | Temozolomide | In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible. |
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In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible. |
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