Trial · NCT00093964
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| 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 | MRT is defined as the mean duration of time a drug molecule is present in the systemic circulation. |
| 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 | CL is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as dose divided by AUC0-infinity. |
| 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 | Vz was calculated as Dose/(AUC0-infinity multiplied by elimination rate constant \[lambda z\]) following single dose. |
| 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 | Vss is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state. |
| Secondary | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the start of treatment up to 6 years | An AE was any untoward medical occurrence in a subject which did not necessarily have a causal relationship with the study drug. A TEAE was any AE that started on or any time after the day of first dose of cilengitide during the treatment phase or within the safety follow-up after last dose of cilengitide. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly. |
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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