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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
CORE is a Phase 2 clinical trial in newly diagnosed glioblastoma in subjects with an unmethylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue.
The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to appear to be a predictive marker for benefit from temozolomide (TMZ) treatment.
In a safety run-in period in dedicated study centers, the safety and tolerability of Cilengitide given as an intense treatment in combination with the first part of standard therapy will be assessed. Thereafter the trial will investigate the overall survival and progression-free survival in subjects receiving two different regimens of Cilengitide in combination with standard treatment versus standard treatment alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilengitide (2-times weekly) + Temozolomide + Radiotherapy | Experimental |
| |
| Cilengitide (5-times weekly) + Temozolomide + Radiotherapy | Experimental |
| |
| Temozolomide + Radiotherapy | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilengitide (2-times weekly) | Drug | Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Time | The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Time - Investigator and Independent Read | The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). |
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Inclusion Criteria:
Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV, including glioblastoma subtypes, for example, gliosarcoma). The histological diagnosis has to be obtained from a neurosurgical resection of the tumor or by an open biopsy (stereotactic biopsy is not allowed)
Tumor tissue specimens from the glioblastoma surgery or open biopsy (formalin-fixed paraffin-embedded) must be available for MGMT gene promoter status analysis and central pathology review
Proven unmethylated MGMT gene promoter status (that is, cut-off ratio less than (<) 2 by means of applied test to determine MGMT gene promoter status)
Males or females greater than or equal to (>=) 18 years of age
Interval of >= 2 weeks but less than or equal to (=<) 7 weeks after surgery or biopsy before first administration of study treatment
Available post-operative gadolinium-enhanced magnetic resonance imaging (Gd-MRI) performed within < 48 hours after surgery
Stable or decreasing dose of steroids for >= 5 days prior to randomization
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1
Has to meet 1 of the following recursive partitioning analysis (RPA) classifications:
Other protocol defined inclusion criteria could apply
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andriy Markivskyy, MD | Merck KGaA, Darmstadt, Germany | Study Director |
| Louis B. Nabors, Prof. Dr. | University of Alabama at Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please Contact U.S. Medical Information Located in | Rockland | Massachusetts | United States | |||
| Please Contact the Merck KGaA Communication Center Located in |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36346112 | Derived | Seliger C, Oppong FB, Lefranc F, Chinot O, Stupp R, Nabors B, Gorlia T, Weller M; EORTC Brain Tumor Group. Association of antidepressant drug use with outcome of patients with glioblastoma. Int J Cancer. 2023 Apr 1;152(7):1348-1359. doi: 10.1002/ijc.34344. Epub 2022 Nov 17. |
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Enrolled: 294 screened for eligibility; 29 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria), 265 participants randomized.
First/last participant (informed consent): Mar 2009/Sep 2011. Clinical data cut-off: 07 Feb 2013, Study completion date: Aug 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| cilengitide (5-times weekly) | Drug | Cilengitide 2000 milligram (mg) will be administered intravenously 5-times weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment. |
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| Temozolomide | Drug | Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] will be administered intravenously once daily from Week 1 to 6. From Week 11 onwards, TMZ will be given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 or until disease progression. |
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| Radiotherapy | Radiation | Radiation therapy (RTX) at a dose of 2 gray (Gy) per fraction will be given once daily, 5 days per week from Week 1 to 6, total dose 60 Gy. |
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| Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013) |
| Maximum Observed Plasma Concentration (Cmax) | The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Days 1 and 5 of Week 1 |
| Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2) | The Tmax and t1/2 for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Days 1 and 5 of Week 1 |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) and Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24]) | The AUC (0-infinity) and AUC (0-24) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Days 1 and 5 of Week 1 |
| Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT) | The Cpre and CT for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Days 1 and 5 of Week 1 |
| Apparent Terminal Rate Constant | The apparent terminal rate constant for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Days 1 and 5 of Week 1 |
| Mean Residence Time From Time 0 to Infinity (MRT [0-infinity]) | The MRT (0-infinity) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Days 1 and 5 of Week 1 |
| Plasma Clearance (CL) | The CL for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Days 1 and 5 of Week 1 |
| Apparent Volume of Distribution During the Terminal Phase (Vz) and Apparent Volume of Distribution at Steady State (Vss) | The Vz (after single dose) and Vss (after repeated doses) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Days 1 and 5 of Week 1 |
| Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4 | An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (Version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome. | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013) |
| Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI-CTC Toxicity Grade 3 or 4 | Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome. | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013) |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013) |
| Darmstadt |
| Germany |
| FG001 | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| FG002 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all the participants who were randomized to study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| BG001 | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| BG002 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) Time | The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. | ITT population included all the participants who were randomized to study treatment. | Posted | Median | 95% Confidence Interval | Months | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013) |
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| Secondary | Progression Free Survival (PFS) Time - Investigator and Independent Read | The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). | ITT population included all the participants who were randomized to study treatment. | Posted | Median | 95% Confidence Interval | Months | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) | The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Days 1 and 5 of Week 1 |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2) | The Tmax and t1/2 for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours | Days 1 and 5 of Week 1 |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) and Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24]) | The AUC (0-infinity) and AUC (0-24) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hour*ng/mL | Days 1 and 5 of Week 1 |
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| Secondary | Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT) | The Cpre and CT for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. One participant had implausible pre-dose concentration. | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 5 of Week 1 |
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| Secondary | Apparent Terminal Rate Constant | The apparent terminal rate constant for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | per hour | Days 1 and 5 of Week 1 |
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| Secondary | Mean Residence Time From Time 0 to Infinity (MRT [0-infinity]) | The MRT (0-infinity) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hour | Days 1 and 5 of Week 1 |
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| Secondary | Plasma Clearance (CL) | The CL for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milliliter per minute | Days 1 and 5 of Week 1 |
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| Secondary | Apparent Volume of Distribution During the Terminal Phase (Vz) and Apparent Volume of Distribution at Steady State (Vss) | The Vz (after single dose) and Vss (after repeated doses) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1. | Only "Cilengitide (5-times) + Temozolomide + Radiotherapy" group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | liter | Days 1 and 5 of Week 1 |
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| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4 | An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (Version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome. | Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period. | Posted | Number | Participants | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013) |
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| Secondary | Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI-CTC Toxicity Grade 3 or 4 | Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome. | Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period. | Posted | Number | Participants | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013) |
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| Secondary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters | Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section | Posted | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013) |
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Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)
Safety population included all participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. 1 participant who was randomized to cilengitide 5-times weekly, but who actually received Cilengitide 2-times weekly was allocated to the cilengitide 2-times weekly treatment group for the safety population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. | 47 | 89 | 83 | 89 | ||
| EG001 | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. | 36 | 81 | 79 | 81 | ||
| EG002 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. | 30 | 85 | 76 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONVULSION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CEREBRAL CYST | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEUROLOGICAL DECOMPENSATION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PARTIAL SEIZURES | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CEREBRAL VENTRICLE DILATATION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| COGNITIVE DISORDER | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSKINESIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| GRAND MAL CONVULSION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEMIANOPIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MOTOR DYSFUNCTION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PYRAMIDAL TRACT SYNDROME | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RADICULAR PAIN | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| UNRESPONSIVE TO STIMULI | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CONDITION AGGRAVATED | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEVICE MALFUNCTION | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| GENERALISED OEDEMA | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| TERMINAL STATE | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MEDIASTINAL HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| VENOUS THROMBOSIS | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| BACTERIAL SEPSIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECI PNEUMONIA | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEOPLASM RECURRENCE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| BRAIN NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| BRAIN STEM GLIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEAVY CHAIN DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| FOOD POISONING | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RETROPERITONEAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| AMYLASE INCREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| FIBRIN D DIMER INCREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| BUNDLE BRANCH BLOCK RIGHT | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PULSELESS ELECTRICAL ACTIVITY | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEPHROTIC SYNDROME | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| OLIGURIA | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RETINAL ARTERY EMBOLISM | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| TOXIC SKIN ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| SOCIAL STAY HOSPITALISATION | Social circumstances | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FATIGUE | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
All manuscripts and materials relating to Study shall be submitted to Sponsor at least 60 days prior to submitting/presenting and allow Sponsor 60 days for review. If Sponsor requests, any confidential information shall be removed. In multi-center study, any publication shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within 1 year from database lock, then Site may publish individually in accordance with this provision.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.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 |
|---|---|
| C422910 | Cilengitide |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| 0.3771 |
P-value is not adjusted for multiple testing. |
| Hazard Ratio (HR) |
| 0.858 |
| 2-Sided |
| 95 |
| 0.612 |
| 1.204 |
| No |
| Superiority or Other |
| Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy |
Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| OG002 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
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Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| OG001 | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| OG002 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
|
|
| OG001 | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator. |
| OG002 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
|
|
| OG002 | Temozolomide + Radiotherapy | TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. |
|