Trial · NCT00093964
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 |
| SECONDARY | Mean Residence Time of Drug in the Body (MRT) | 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 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. | Hour (h) | MEAN |
| SECONDARY | Total Body Clearance (CL) of Drug From Plasma/Cerebro Spinal Fluid (CSF) | 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 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. | Liter per hour (L/h) | MEAN |
| SECONDARY | Apparent Volume of Distribution During the Terminal Phase (Vz) | 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 included the subjects who had received cilengitide and who had had blood samples drawn in Week 1 and/or 5 that provided drug concentration for non-compartmental PK evaluation. Here, Number of participants analysed signifies those subjects who were evaluable for this outcome measure. | Liter (L) | MEAN |
| SECONDARY | Apparent Volume of Distribution at Steady State (Vss) | 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 PK population included the subjects who had received cilengitide and who had blood samples drawn in Week 1 and/or 5 that provided drug concentration for non-compartmental PK evaluation. Here, Number of participants analysed signifies those subjects who were evaluable for this outcome measure. | Liter (L) | MEAN |
| SECONDARY | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the start of treatment up to 6 years | The safety population included all randomized subjects who had received at least 1 intravenous administration of cilengitide. | subjects | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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