Trial · NCT00093964
Cilengitide (EMD 121974) for Recurrent Glioblastoma Multiforme (Brain Tumor)
NCT00093964, Phase 2, Completed, EMD Serono; results first posted 2019-04-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cilengitide (EMD 121974) for Recurrent Glioblastoma Multiforme (Brain Tumor). Trials, record NCT00093964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00093964
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cilengitide (EMD 121974) for Recurrent Glioblastoma Multiforme (Brain Tumor)
- NCT number
- NCT00093964
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Glioblastoma Multiforme
- Interventions
- Cilengitide 500 mg, Cilengitide 2000 mg
- First posted
- 2004-10-11
- Last updated
- 2019-04-16
- Results first posted
- 2019-04-16
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Progression-free Survival | Month 6 | Progression-free survival was defined as subjects who survived greater than or equal to (\>=) 180 days without disease progression. Disease progression was assessed as per independent central blinded radiology assessment. |
| Secondary | Percentage of Subjects With Overall Response Rate | From the start of treatment up to 6 years | Overall response rate was defined as percentage of subjects who had best response during the study which was either complete response (CR: disappearance of all tumors, no new lesions and stable or improved neurological examination) or partial response (PR: \>= reduction in the sum of the products of the largest perpendicular diameters compared to the baseline sum, no worsening of evaluable lesion and stable or improved neurological examination). CR or PR was confirmed within 31 days with a repeat neuroimaging. |
| Secondary | Time to Disease Progression | From the start of treatment until disease progression (assessed up to a maximum of 6 years) | Time to disease progression was defined as the number of days between the first dose and the date of first assessment of progressive disease during the study or until death. Surviving subjects without progressive disease were censored at the time of the last visit and the subject was known to be non-progressing. Disease progression was assessed as per independent central blinded radiology assessment. |
| Secondary | Overall Survival Time | From the start of treatment until death (assessed up to a maximum of 6 years) | Survival time was defined as the number of months between the date of randomization and the date of death or the last date the subject was known to be alive. |
| Secondary | Percentage of Subjects With 1-year of Survival Rate | From the start of treatment up to 1 year | 1-year survival rate was defined as percentage of subjects who survived for \>=365 days with or without disease progression. Disease progression was assessed as per independent central blinded radiology assessment. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Pre-dose, 1, 1.5, 2, 3, 4, 8, 24 hours post-infusion on Day 1 of Week 1 in Cycle 1 and 2 | Cmax is the maximum observed plasma concentration of cilengitide after administration. |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) | Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2 | Tmax is the time to reach the maximum plasma concentration (Cmax) of cilengitide. |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity After Administration (AUC 0-infinity) | Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2 | AUC 0-infinity is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration of cilengitide. |
| Secondary | Apparent Terminal Rate Constant (Lambda z) | Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2 | Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. |
| Secondary | Terminal Half-life (t1/2) | Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2 | The t1/2 is the time taken to eliminate half the amount of cilengitide. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Progression-free Survival | Month 6 | The intention-to-treat (ITT) population included all randomized subjects who had received at least 1 intravenous administration of cilengitide. Here,Number of participants analyzed signifies those subjects who were evaluable for this outcome measure. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Overall Response Rate | From the start of treatment up to 6 years | ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide. Here,Number of participants analysed signifies those subjects who were evaluable for this outcome measure. | percentage of subjects | NUMBER |
| SECONDARY | Time to Disease Progression | From the start of treatment until disease progression (assessed up to a maximum of 6 years) | ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide. | months | MEDIAN |
| SECONDARY | Overall Survival Time | From the start of treatment until death (assessed up to a maximum of 6 years) | ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide. | months | MEDIAN |
| SECONDARY | Percentage of Subjects With 1-year of Survival Rate | From the start of treatment up to 1 year | ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide. | percentage of subjects | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) | Pre-dose, 1, 1.5, 2, 3, 4, 8, 24 hours post-infusion on Day 1 of Week 1 in Cycle 1 and 2 | The pharmacokinetic (PK) population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category. | microgram per milliliter (mcg/mL) | MEAN |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) | Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2 | The PK population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category. | Hour (h) | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity After Administration (AUC 0-infinity) | Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2 | The PK population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category. | Microgram per milliliter*hour (mcg/mL*h) | MEAN |
| SECONDARY | Apparent Terminal Rate Constant (Lambda z) | Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2 | The PK population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category. | Per hour (/h) | MEAN |
| SECONDARY | Terminal Half-life (t1/2) | Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2 | The PK population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category. | Hour (h) | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Progression-free Survival | Cilengitide 500 Milligrams (mg) | 7.5 | 95% Confidence Interval 1.6 to 20.4 | percentage of subjects | |
| Percentage of Subjects With Progression-free Survival | Cilengitide 2000 mg | 15.0 | 95% Confidence Interval 5.7 to 29.8 | percentage of subjects | |
| Percentage of Subjects With Overall Response Rate | Cilengitide 500 Milligrams (mg) | 5.0 | 95% Confidence Interval 0.6 to 16.9 | percentage of subjects | |
| Percentage of Subjects With Overall Response Rate | Cilengitide 2000 mg | 12.5 | 95% Confidence Interval 4.2 to 26.8 | percentage of subjects | |
| Time to Disease Progression | Cilengitide 500 Milligrams (mg) | 1.81 | Full Range 0.39 to 56.71 | months | |
| Time to Disease Progression | Cilengitide 2000 mg | 1.91 | Full Range 0.66 to 57.76 | months | |
| Overall Survival Time | Cilengitide 500 Milligrams (mg) | 6.54 | Full Range 1.45 to 65.92 | months | |
| Overall Survival Time | Cilengitide 2000 mg | 9.91 | Full Range 0.92 to 67.23 | months | |
| Percentage of Subjects With 1-year of Survival Rate | Cilengitide 500 Milligrams (mg) | 22.0 | 95% Confidence Interval 10.9 to 35.5 | percentage of subjects | |
| Percentage of Subjects With 1-year of Survival Rate | Cilengitide 2000 mg | 37.5 | 95% Confidence Interval 22.9 to 52.1 | percentage of subjects |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cilengitide 500 Milligram (mg) | 41 | |
| Overall Study | STARTED | Cilengitide 2000 mg | 40 | |
| Overall Study | COMPLETED | Cilengitide 500 Milligram (mg) | 41 | |
| Overall Study | COMPLETED | Cilengitide 2000 mg | 40 | |
| Overall Study | NOT COMPLETED | Cilengitide 500 Milligram (mg) | 0 | |
| Overall Study | NOT COMPLETED | Cilengitide 2000 mg | 0 |
Source ClinicalTrials.gov
Adverse events686
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 | Haemoglobinaemia | Blood and lymphatic system disorders | Cilengitide 500 Milligram (mg) | 1 | 41 | |
| other | Haemoglobinaemia | Blood and lymphatic system disorders | Cilengitide 2000 mg | 0 | 40 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cilengitide 500 Milligram (mg) | 0 | 41 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cilengitide 2000 mg | 1 | 40 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cilengitide 500 Milligram (mg) | 2 | 41 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cilengitide 2000 mg | 2 | 40 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cilengitide 500 Milligram (mg) | 1 | 41 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cilengitide 2000 mg | 1 | 40 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cilengitide 500 Milligram (mg) | 2 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cilengitide 2000 mg | 1 | 40 |
1 to 10 of 686Source ClinicalTrials.gov
See all 686 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilengitide 500 Milligram (mg) | ||
| Total, all-cause mortality | Cilengitide 2000 mg | ||
| Total, other adverse events | Cilengitide 500 Milligram (mg) | 41 | 41 |
| Total, other adverse events | Cilengitide 2000 mg | 39 | 40 |
| Total, serious adverse events | Cilengitide 500 Milligram (mg) | 16 | 41 |
| Total, serious adverse events | Cilengitide 2000 mg | 18 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18981465 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cilengitide 500 Milligram (mg) vs Cilengitide 2000 mg: serious adverse events |
Source Trial comparisons
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/NCT00093964
GET https://conductscience.org/api/trials/v1/NCT00093964/results?page=2