Trial · NCT00813943
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| 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 | 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 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. | Participants | NUMBER |
| 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 | 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 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. | Participants | NUMBER |
| SECONDARY | 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) | 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 |
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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