Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022189-28 | EudraCT Number | ||
| ITCC-019 | Other Identifier | Innovative Therapies for Children with Cancer Consortium (ITCC) | |
| HGG-01 | Other Identifier | SIOP-E-Brain Tumour Group |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be randomly assigned to one of two treatment arms.
Upon approval by the Health Authorities/Ethics Committees in the participating countries, an additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + TMZ Young Patient Cohort (YPC) | Experimental | Participants aged greater than or equal to (>/=) 6 months and less than (<) 3 years will receive 10 milligrams per kilogram (mg/kg) Bevacizumab every 2 weeks and 150 to 200 milligrams per meter squared (mg/m^2) of TMZ daily on Days 1-5 of each cycle. TMZ will be given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. |
|
| Main Cohort: Chemoradiation + Bevacizumab + TMZ | Experimental | Participants will receive a total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break will be followed by an adjuvant treatment phase where participants will receive 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ will be given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab will be given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period. |
|
| Main Cohort: Chemoradiation + TMZ | Active Comparator | Participants will receive a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break will be followed by an adjuvant treatment phase where participants will receive 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ will be given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 10 milligrams per kilogram every 2 weeks during the study for up to 12 cycles, each cycle length of 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC) | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using magnetic resonance imaging (MRI) and reviewed by the site-independent CRRC using Response Assessment in Neuro-Oncology (RANO) criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. | From the time of randomization to the date of any defined event (up to 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival was defined as the time of diagnosis to the date of death due to any cause. Overall Survival was estimated using the Kaplan-Meier method. | From the time of randomization to the date of death (up to approximately 60 months) |
| Percentage of Participants With 1-Year Survival |
Not provided
Inclusion Criteria - Main cohort :
Young Participant Cohort
Exclusion Criteria - Main cohort:
Young Participant Cohort
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia | ||
| Lady Cilento Children's Hospital; Oncology Services Group, Level 12b |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35412366 | Derived | Rodriguez D, Calmon R, Aliaga ES, Warren D, Warmuth-Metz M, Jones C, Mackay A, Varlet P, Le Deley MC, Hargrave D, Canete A, Massimino M, Azizi AA, Saran F, Zahlmann G, Garcia J, Vassal G, Grill J, Peet A, Dineen RA, Morgan PS, Jaspan T. MRI and Molecular Characterization of Pediatric High-Grade Midline Thalamic Gliomas: The HERBY Phase II Trial. Radiology. 2022 Jul;304(1):174-182. doi: 10.1148/radiol.211464. Epub 2022 Apr 12. | |
| 31419298 |
Not provided
Not provided
Chemoradiation + temozolomide (TMZ) and Chemoradiation + Bevacizumab + TMZ arms: 174 participants were screened; 121 were randomized; 116 received study treatment. Young Patient Cohort: 4 participants were screened; 3 were enrolled and received study treatment (these subjects were not randomized and are not included in efficacy analyses).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Chemoradiation + TMZ | Participants received a total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 milligrams per meter squared (mg/m^2) TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Radiotherapy | Radiation | Total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks during the chemoradiation phase. |
|
| Temozolomide (TMZ) | Drug | 75 milligrams per square meter (mg/m^2) daily continuous starting concomitantly with the first radiation fraction and ending with the last radiation fraction for a maximum number of treatment days = 49 days. During the TMZ adjuvant treatment phase and for participants from YPC: TMZ (150 to 200 mg/m^2/day) x 12 cycles, 1st cycle 150 mg/m^2/days 1-5, escalated to 200 mg/m^2 on Days 1-5 from Cycle 2 onwards depending on the tolerance during the 1st cycle. Cycle length = 28 days. |
|
1-year survival was estimated using the Kaplan-Meier method. |
| 1 year after end of treatment |
| Percentage of Participants With EFS as Determined by the CRRC at 6 Months | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. | 6 months |
| Percentage of Participants With EFS as Determined by the CRRC at 1 Year | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. | 1 year |
| EFS as Assessed by the Investigator | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the investigator using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. | From the time of randomization to the date of any defined event (up to 12 months) |
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) determined on two consecutive occasions >/= 4 weeks apart. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. The following were needed to qualify as CR: complete disappearance of all measurable enhancing lesions sustained for at least 4 weeks by MRI, no steroids above physiological levels, clinical status stable or improved compared to baseline. The following were needed to qualify as PR: ≥ 50% decrease from baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks by MRI, steroid dose not increased compared to baseline, clinical status stable or improved compared to baseline. | From the time of randomization to the date of any defined event (up to 12 months) |
| Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival | Concordance is presented as the percentage of participants with concordance between assessments. EFS concordance was defined as event Structural assessment and Diffusion Perfusion assessment occurs within 28 days or no event Structural and no Diffusion Perfusion. | Up to 12 months |
| Health Status as Measured by the Health Utility Index (HUI) | HUI is a preference-based, multi-attitude, health-related instrument specifically developed for use with children. HUI consists of eight attributes of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. Each attribute had 5 or 6 levels varying from highly impaired to normal. Each of the eight health dimensions was tested separately and a composite score ranging between 1 (perfect health) and 0 (death) was obtained for participants aged 5 years or older. | Baseline, Cycle 6 of the adjuvant phase, end of treatment (approximately 58 weeks post-baseline), and yearly during the follow-up period (maximum 5 years in follow-up) |
| Neurological Psychological Function as Measured by the Wechsler Scale | The Wechsler Intelligence Scale for Children version IV (WISC-IV) was used to generate a full scale intelligence quotient (IQ) which represents a child's general intellectual ability. The average IQ score is 100, with lower scores representing lower intellectual ability. | End of treatment (approximately 58 weeks post-baseline) |
| Percentage of Participants Who Completed >/= 90% of Planned Radiotherapy and TMZ Administrations | From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months) |
| Percentage of Participants With a Treatment Delay or Discontinuation | From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months) |
| Number of Radiotherapy Dose Administrations in the Concurrent Phase | Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks. | Beginning of the concurrent phase to end of treatment break (10 weeks) |
| Number of Dose Administrations of TMZ and Bevacizumab in the Concurrent Phase | Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks. | Beginning of the concurrent phase to end of treatment break (10 weeks) |
| Percentage of Participants With an Adverse Event (AE) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months) |
| South Brisbane |
| Queensland |
| QLD 4101 |
| Australia |
| Kepler Universitätskliniken GmbH - Med Campus IV. | Linz | 4020 | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Alberta Children'S Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| Hospital For Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Fakultni nemocnice Brno; 2. detska klinika, pracoviste Detska nemocnice | Brno | 62500 | Czechia |
| Fakultni Nemocnice V Motole, S.P. | Prague | 15060 | Czechia |
| Skejby Sygehus - Aarhus University Hospital; CF Center, Børneafdeling A | Aarhus N | 8200 | Denmark |
| Rigshospitalet; Onkologisk Klinik | København Ø | 2100 | Denmark |
| Centre Hospitalier d'Angers; Service de cancérologie pédiatrique | Angers | 49033 | France |
| CHU ESTAING; Centre Regional de Cancérologie et Thérapie Cellulaire Pédiatrique (CRCTCP) | Clermont-Ferrand | 63003 | France |
| Centre Oscar Lambret; Service de Pediatrie | Lille | 59020 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Hopital Timone Enfants; Onco Pediatrie | Marseille | 13385 | France |
| Hopital Lenval; Service Hématologie Infantile | Nice | 06200 | France |
| Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique | Paris | 75248 | France |
| CHRU de Rennes - Hôpital Sud- Service d'Hématologie Pédiatrique | Rennes | 35056 | France |
| Hopital Nord;Consult Pediatrie | Saint-Priest-en-Jarez | 42777 | France |
| Hôpital Hautepierre | Strasbourg | 67200 | France |
| Hopital Des Enfants; Service d Hemato-Oncologie | Toulouse | 31059 | France |
| CHRU de Tours - Centre de Pédiatrie Clocheville; Service d'Oncopédiatrie | Tours | 37044 | France |
| Hopital Brabois Enfants | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy; Service Pediatrique | Villejuif | 94805 | France |
| Semmelweis University, 2nd Dept of Pediatrics Neurooncology Unit | Budapest | 1094 | Hungary |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh | Bologna | Emilia-Romagna | 40138 | Italy |
| Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS; U.O.S. Neuroncologia | Genoa | Liguria | 16147 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Azienda Ospedaliera di Padova | Padova | Veneto | 35128 | Italy |
| UMC St Radboud | Nijmegen | 6525 GA | Netherlands |
| Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology | Rotterdam | 3015 GJ | Netherlands |
| Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii | Warsaw | 04-746 | Poland |
| Hospital Sant Joan De Deu | Esplugues de Llobregas | Barcelona | 08950 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Fe | Valencia | 46014 | Spain |
| Sahlgrenska Universitetssjukhuset, Östra Sjukhus; Drottning Silvias Barnsjukhus | Gothenburg | 416 85 | Sweden |
| Universitetssjukhuset Linköping; Barn och Ungdomskliniken | Linköping | 581 85 | Sweden |
| Skånes Universitetssjukhus | Lund | 221 85 | Sweden |
| Karolinska Universitetssjukhuset, Solna; Astrid Lindgrens Barnsjukhus, Barcanceravdelningen | Solna | 171 76 | Sweden |
| Birmingham Childrens Hospital; Oncology Dept | Birmingham | B4 6NH | United Kingdom |
| Bristol Royal Hospital for Children; Paediatric Haematology, Oncology, BMT | Bristol | BS2 8BJ | United Kingdom |
| Addenbrookes Hospital; Paediatric Oncology Ward C2 | Cambridge | CB2 0QQ | United Kingdom |
| Royal Hospital for Sick Children | Edinburgh | EH91LF | United Kingdom |
| Leeds General Infirmary; Ward 35 | Leeds | LS1 3EX | United Kingdom |
| Alder Hey Children's NHS Foundation Trust | Liverpool | L12 2AP | United Kingdom |
| University College London NHS Foundation Trust | London | NW1 2PG | United Kingdom |
| Great Ormond Street Hospital; Dept. Of Pediatric Oncology | London | WC1N 3JH | United Kingdom |
| Royal Manchester Childrens Hospital | Manchester | M13 9WL | United Kingdom |
| Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Queens Medical Centre | Nottingham | NG7 2UH | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Royal Marsden Hospital; Pediatric Unit | Surrey | SM2 5PT | United Kingdom |
| Derived |
| Varlet P, Le Teuff G, Le Deley MC, Giangaspero F, Haberler C, Jacques TS, Figarella-Branger D, Pietsch T, Andreiuolo F, Deroulers C, Jaspan T, Jones C, Grill J. WHO grade has no prognostic value in the pediatric high-grade glioma included in the HERBY trial. Neuro Oncol. 2020 Jan 11;22(1):116-127. doi: 10.1093/neuonc/noz142. |
| 30819765 | Derived | Rodriguez D, Chambers T, Warmuth-Metz M, Aliaga ES, Warren D, Calmon R, Hargrave D, Garcia J, Vassal G, Grill J, Zahlmann G, Morgan PS, Jaspan T. Evaluation of the Implementation of the Response Assessment in Neuro-Oncology Criteria in the HERBY Trial of Pediatric Patients with Newly Diagnosed High-Grade Gliomas. AJNR Am J Neuroradiol. 2019 Mar;40(3):568-575. doi: 10.3174/ajnr.A5982. Epub 2019 Feb 28. |
| 29763623 | Derived | Mackay A, Burford A, Molinari V, Jones DTW, Izquierdo E, Brouwer-Visser J, Giangaspero F, Haberler C, Pietsch T, Jacques TS, Figarella-Branger D, Rodriguez D, Morgan PS, Raman P, Waanders AJ, Resnick AC, Massimino M, Garre ML, Smith H, Capper D, Pfister SM, Wurdinger T, Tam R, Garcia J, Thakur MD, Vassal G, Grill J, Jaspan T, Varlet P, Jones C. Molecular, Pathological, Radiological, and Immune Profiling of Non-brainstem Pediatric High-Grade Glioma from the HERBY Phase II Randomized Trial. Cancer Cell. 2018 May 14;33(5):829-842.e5. doi: 10.1016/j.ccell.2018.04.004. |
| 29412784 | Derived | Grill J, Massimino M, Bouffet E, Azizi AA, McCowage G, Canete A, Saran F, Le Deley MC, Varlet P, Morgan PS, Jaspan T, Jones C, Giangaspero F, Smith H, Garcia J, Elze MC, Rousseau RF, Abrey L, Hargrave D, Vassal G. Phase II, Open-Label, Randomized, Multicenter Trial (HERBY) of Bevacizumab in Pediatric Patients With Newly Diagnosed High-Grade Glioma. J Clin Oncol. 2018 Apr 1;36(10):951-958. doi: 10.1200/JCO.2017.76.0611. Epub 2018 Feb 7. |
| FG001 | Chemoradiation + Bevacizumab + TMZ | Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks throughout the entire treatment period. |
| FG002 | Bevacizumab + TMZ Young Patient Cohort (YPC) | Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chemoradiation + TMZ | Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. |
| BG001 | Chemoradiation + Bevacizumab + TMZ | Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period. |
| BG002 | Bevacizumab + TMZ Young Patient Cohort (YPC) | Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. |
| BG003 | 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC) | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using magnetic resonance imaging (MRI) and reviewed by the site-independent CRRC using Response Assessment in Neuro-Oncology (RANO) criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. | Randomized participant population included all randomized participants regardless of whether they received study treatment. | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the date of any defined event (up to 12 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival was defined as the time of diagnosis to the date of death due to any cause. Overall Survival was estimated using the Kaplan-Meier method. | Randomized participant population included all randomized participants regardless of whether they received study treatment. | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the date of death (up to approximately 60 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With 1-Year Survival | 1-year survival was estimated using the Kaplan-Meier method. | Randomized participant population included all randomized participants regardless of whether they received study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year after end of treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With EFS as Determined by the CRRC at 6 Months | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. | Randomized participant population included all randomized participants regardless of whether they received study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With EFS as Determined by the CRRC at 1 Year | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. | Randomized participant population included all randomized participants regardless of whether they received study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EFS as Assessed by the Investigator | EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the investigator using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method. | Randomized participant population included all randomized participants regardless of whether they received study treatment. | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the date of any defined event (up to 12 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) determined on two consecutive occasions >/= 4 weeks apart. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. The following were needed to qualify as CR: complete disappearance of all measurable enhancing lesions sustained for at least 4 weeks by MRI, no steroids above physiological levels, clinical status stable or improved compared to baseline. The following were needed to qualify as PR: ≥ 50% decrease from baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks by MRI, steroid dose not increased compared to baseline, clinical status stable or improved compared to baseline. | Randomized participant population with a measurable lesion at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | From the time of randomization to the date of any defined event (up to 12 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival | Concordance is presented as the percentage of participants with concordance between assessments. EFS concordance was defined as event Structural assessment and Diffusion Perfusion assessment occurs within 28 days or no event Structural and no Diffusion Perfusion. | Randomized participant population included all randomized participants regardless of whether they received study treatment. | Posted | Number | percentage of participants | Up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Status as Measured by the Health Utility Index (HUI) | HUI is a preference-based, multi-attitude, health-related instrument specifically developed for use with children. HUI consists of eight attributes of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. Each attribute had 5 or 6 levels varying from highly impaired to normal. Each of the eight health dimensions was tested separately and a composite score ranging between 1 (perfect health) and 0 (death) was obtained for participants aged 5 years or older. | Randomized participant population aged 5 years or older with a measure at the specified time point. Here, 'n' represents the number of participants with a measure at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Cycle 6 of the adjuvant phase, end of treatment (approximately 58 weeks post-baseline), and yearly during the follow-up period (maximum 5 years in follow-up) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Neurological Psychological Function as Measured by the Wechsler Scale | The Wechsler Intelligence Scale for Children version IV (WISC-IV) was used to generate a full scale intelligence quotient (IQ) which represents a child's general intellectual ability. The average IQ score is 100, with lower scores representing lower intellectual ability. | Randomized participant population included all randomized participants regardless of whether they received study treatment. | Posted | Mean | Standard Deviation | units on a scale | End of treatment (approximately 58 weeks post-baseline) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Completed >/= 90% of Planned Radiotherapy and TMZ Administrations | Safety population included all participants that received study treatment. | Posted | Number | percentage of participants | From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Treatment Delay or Discontinuation | Randomized participant population included all randomized participants regardless of whether they received study treatment. | Posted | Number | percentage of participants | From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Radiotherapy Dose Administrations in the Concurrent Phase | Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks. | Safety population included all participants that received study drug. | Posted | Median | Full Range | Grays | Beginning of the concurrent phase to end of treatment break (10 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Dose Administrations of TMZ and Bevacizumab in the Concurrent Phase | Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks. | Safety population included all participants that received study drug. | Posted | Median | Full Range | number of dose administrations | Beginning of the concurrent phase to end of treatment break (10 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Adverse Event (AE) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Safety population included all participants that received study drug. | Posted | Number | percentage of participants | From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months) |
|
From randomization/enrollment of the first participant to date of clinical cut off (approximately 60 months)
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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 | Chemoradiation + TMZ | Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. | 27 | 56 | 56 | 56 | ||
| EG001 | Chemoradiation + Bevacizumab + TMZ | Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period. | 35 | 60 | 60 | 60 | ||
| EG002 | Bevacizumab + TMZ Young Patient Cohort (YPC) | Participants aged >/= 6 months and < 3 years received 10 mg/kg Bevacizumab every 2 weeks and 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. | 0 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PRECOCIOUS PUBERTY | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EYELID OEDEMA | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CATHETER SITE THROMBOSIS | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CYST | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOTHERMIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| IMPLANT SITE DEHISCENCE | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CATHETER SITE INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| DEVICE RELATED SEPSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| KLEBSIELLA BACTERAEMIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PSEUDOMONAS INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| HAEMATURIA TRAUMATIC | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| BODY TEMPERATURE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ATYPICAL TERATOID/RHABDOID TUMOUR OF CNS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| B-CELL TYPE ACUTE LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| OSTEOSARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| CEREBRAL CYST | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CEREBROSPINAL FLUID LEAKAGE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MONOPLEGIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NERVOUS SYSTEM DISORDER | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PARTIAL SEIZURES | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| STATUS EPILEPTICUS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEVICE OCCLUSION | Product Issues | MedDRA 22.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EYE PAIN | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DENTAL CARIES | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CANDIDA INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| OTITIS MEDIA ACUTE | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| RADIATION INJURY | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| HEART RATE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INTRACRANIAL PRESSURE INCREASED | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PURPURA | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SKIN STRIAE | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
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 | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| 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 |
| D011878 | Radiotherapy |
| 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 |
| D013812 | Therapeutics |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >/= 3 years and < 6 years |
|
| >/= 6 years and < 13 years |
|
| >/= 13 years and < 18 years |
|
| Male |
|
|
|
|
|
| OG001 | Chemoradiation + Bevacizumab + TMZ | Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period. |
|
|
| OG001 | Chemoradiation + Bevacizumab + TMZ | Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period. |
|
|
| OG001 | Chemoradiation + Bevacizumab + TMZ | Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period. |
|
|
| OG001 |
| Chemoradiation + Bevacizumab + TMZ |
Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period. |
|
|
|
|
Participants received a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break was followed by an adjuvant treatment phase where participants received 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ was given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab was given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|