Trial · NCT00813943
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status
NCT00813943, Phase 2, Completed, EMD Serono; results first posted 2014-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status. Trials, record NCT00813943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00813943
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status
- NCT number
- NCT00813943
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 265 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Glioblastoma
- Interventions
- Cilengitide (2-times weekly), cilengitide (5-times weekly), Temozolomide, Radiotherapy
- First posted
- 2008-12-23
- Last updated
- 2017-01-30
- Results first posted
- 2014-12-08
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) Time | 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) | 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. |
| Secondary | Progression Free Survival (PFS) Time - Investigator and Independent Read | 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) | 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). |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Days 1 and 5 of Week 1 | 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. |
| Secondary | Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2) | Days 1 and 5 of Week 1 | 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. |
| 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]) | Days 1 and 5 of Week 1 | 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. |
| Secondary | Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT) | Days 1 and 5 of Week 1 | 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. |
| Secondary | Apparent Terminal Rate Constant | Days 1 and 5 of Week 1 | 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. |
| Secondary | Mean Residence Time From Time 0 to Infinity (MRT [0-infinity]) | Days 1 and 5 of Week 1 | 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. |
| Secondary | Plasma Clearance (CL) | Days 1 and 5 of Week 1 | 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. |
| Secondary | Apparent Volume of Distribution During the Terminal Phase (Vz) and Apparent Volume of Distribution at Steady State (Vss) | Days 1 and 5 of Week 1 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) Time | 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) | ITT population included all the participants who were randomized to study treatment. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Time - Investigator and Independent Read | 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) | ITT population included all the participants who were randomized to study treatment. | Months | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) | Days 1 and 5 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. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2) | Days 1 and 5 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. | hours | MEAN |
| 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]) | Days 1 and 5 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. | hour*ng/mL | MEAN |
| SECONDARY | Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT) | Days 1 and 5 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. | ng/mL | MEAN |
| SECONDARY | Apparent Terminal Rate Constant | Days 1 and 5 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. | per hour | MEAN |
| SECONDARY | Mean Residence Time From Time 0 to Infinity (MRT [0-infinity]) | Days 1 and 5 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. | hour | MEAN |
| SECONDARY | Plasma Clearance (CL) | Days 1 and 5 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. | milliliter per minute | MEAN |
| SECONDARY | Apparent Volume of Distribution During the Terminal Phase (Vz) and Apparent Volume of Distribution at Steady State (Vss) | Days 1 and 5 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. | liter | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group61
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) Time | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | 16.3 | 95% Confidence Interval 13.2 to 18.1 | Months | |
| Overall Survival (OS) Time | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | 14.5 | 95% Confidence Interval 12.6 to 16.5 | Months | |
| Overall Survival (OS) Time | Temozolomide + Radiotherapy | 13.4 | 95% Confidence Interval 12.2 to 14.3 | Months | |
| Progression Free Survival (PFS) Time - Investigator and Independent Read | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | PFS Time: Independent read | 5.6 | 95% Confidence Interval 3.6 to 5.9 | Months |
| Progression Free Survival (PFS) Time - Investigator and Independent Read | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | PFS Time: Independent read | 5.9 | 95% Confidence Interval 4.2 to 7.6 | Months |
| Progression Free Survival (PFS) Time - Investigator and Independent Read | Temozolomide + Radiotherapy | PFS Time: Independent read | 4.1 | 95% Confidence Interval 3.7 to 4.7 | Months |
| Progression Free Survival (PFS) Time - Investigator and Independent Read | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | PFS Time: Investigator read | 6.4 | 95% Confidence Interval 4.2 to 7.9 | Months |
| Progression Free Survival (PFS) Time - Investigator and Independent Read | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | PFS Time: Investigator read | 7.5 | 95% Confidence Interval 5.9 to 8.2 | Months |
| Progression Free Survival (PFS) Time - Investigator and Independent Read | Temozolomide + Radiotherapy | PFS Time: Investigator read | 6.0 | 95% Confidence Interval 4.1 to 7.7 | Months |
| Maximum Observed Plasma Concentration (Cmax) | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | Day 1 (Single dose) | 108527 | Standard Deviation 27197 | nanogram per milliliter (ng/mL) |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | 88 | |
| Overall Study | STARTED | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | 88 | |
| Overall Study | STARTED | Temozolomide + Radiotherapy | 89 | |
| Overall Study | COMPLETED | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | 83 | |
| Overall Study | COMPLETED | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | 83 | |
| Overall Study | COMPLETED | Temozolomide + Radiotherapy | 86 | |
| Overall Study | NOT COMPLETED | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | 5 | |
| Overall Study | NOT COMPLETED | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | 5 | |
| Overall Study | NOT COMPLETED | Temozolomide + Radiotherapy | 3 |
Source ClinicalTrials.gov
Adverse events483
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | FATIGUE | General disorders | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | 27 | 89 | |
| other | FATIGUE | General disorders | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | 21 | 81 | |
| other | FATIGUE | General disorders | Temozolomide + Radiotherapy | 19 | 85 | |
| other | ASTHENIA | General disorders | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | 22 | 89 | |
| other | ASTHENIA | General disorders | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | 24 | 81 | |
| other | ASTHENIA | General disorders | Temozolomide + Radiotherapy | 11 | 85 | |
| other | PYREXIA | General disorders | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | 16 | 89 | |
| other | PYREXIA | General disorders | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | 14 | 81 | |
| other | PYREXIA | General disorders | Temozolomide + Radiotherapy | 8 | 85 | |
| other | OEDEMA PERIPHERAL | General disorders | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | 9 | 89 |
1 to 10 of 483Source ClinicalTrials.gov
See all 483 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | ||
| Total, all-cause mortality | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | ||
| Total, all-cause mortality | Temozolomide + Radiotherapy | ||
| Total, other adverse events | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | 83 | 89 |
| Total, other adverse events | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | 79 | 81 |
| Total, other adverse events | Temozolomide + Radiotherapy | 76 | 85 |
| Total, serious adverse events | Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy | 47 | 89 |
| Total, serious adverse events | Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy | 36 | 81 |
| Total, serious adverse events | Temozolomide + Radiotherapy | 30 | 85 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36346112 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00813943
GET https://conductscience.org/api/trials/v1/NCT00813943/results?page=2