Trial · NCT00510068
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The Full Analysis Set (FAS) consists of all patients who were randomized. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response}) | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The Full Analysis Set (FAS) consists of all patients who were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival | Baseline, to death- no time limit | The Full Analysis Set (FAS) included all randomized patients. | Months | MEDIAN |
| SECONDARY | Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5% | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The Full Analysis Set (FAS) consisted of all patients who were randomized. | Months | MEDIAN |
| SECONDARY | Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The Full Analysis Set (FAS) consisted of all patients who were randomized. | Months | MEDIAN |
| SECONDARY | Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response | Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 | The Full Analysis Set (FAS) consisted of all patients who were randomized. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) | on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation | The Safety Set consists of all patients who received any study drug and had at least one post-baseline safety assessment. | Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period) | on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation | The open-label set was used to summarize the safety analyses performed on data collected in the open-label period of the study: the open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study. | Participants | NUMBER |
| SECONDARY | Evaluation of Pharmacokinetics (PK) Parameter: AUC0-t Last | Day 1 of every cycle (28 days/cycle) throughout the study | The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment. | ng.h/mL | MEAN |
| SECONDARY | Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin | Day 1 of every cycle (28 days/cycle) throughout the study | The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment. | ng/mL | MEAN |
| SECONDARY | Evaluation of Pharmacokinetics (PK) Parameter: CL/F | Day 1 of every cycle (28 days/cycle) throughout the study | The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment. | L/h | MEAN |
| SECONDARY | Evaluation of Pharmacokinetics (PK) Parameter: Tmax -Time to Maximum (Peak) Drug Concentration | Day 1 of every cycle (28 days/cycle) throughout the study | The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment. | h | MEDIAN |
| SECONDARY | Analysis of Time to Definitive Deterioration of WHO Performance Status Using Kaplan-Meier | 3 months, 6 months | The Full Analysis Set (FAS) consists of all patients who were randomized. | % of participants with no deterioration | NUMBER |
| SECONDARY | Plasma Angiogenesis Marker: Basic Fibroblast Growth Factor (bFGF) | Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 | The Full Analysis Set (FAS) consists of all patients who were randomized. | pg/mL | MEAN |
| SECONDARY | Plasma Angiogenesis Marker: Placental Growth Factor (PLGF) | Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 | The Full Analysis Set (FAS) consists of all patients who were randomized. | pg/mL | MEAN |
| SECONDARY | Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 1 (sVEGFR1) | Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 | The Full Analysis Set (FAS) consists of all patients who were randomized. | pg/mL | MEAN |
| SECONDARY | Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2) | Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 | The Full Analysis Set (FAS) consists of all patients who were randomized. | pg/mL | MEAN |
| SECONDARY | Plasma Angiogenesis Marker: Vascular Endothelial Growth Factor (VEGF) | Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 | The Full Analysis Set (FAS) consists of all patients who were randomized. | pg/mL | MEAN |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT00510068/outcomes