Trial · NCT00679354
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 | Objective Response to Cilengitide | Up to 16 weeks | Six patients are considered inevaluable for objective response (including one ineligible patient) and excluded from analysis. | participants | NUMBER |
| SECONDARY | Time to Tumor Progression (TTP) | Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 5 years | 29 eligible patients are included in the analysis. | Days | MEDIAN |
| SECONDARY | Time to Treatment Failure (TTF) | Time from study enrollment to tumor progression, tumor recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 5 years | Twenty-nine eligible patients are included in the analysis. | Days | MEDIAN |
| SECONDARY | Time to Death (TTD) | Time from study enrollment to death from any cause, assessed up to 5 years | Twenty-nine eligible patients are included in the analysis. | Days | MEDIAN |
| SECONDARY | Rate of Toxicity, Especially That of Symptomatic Intratumoral Hemorrhage (ITH) Assessed by Common Terminology Criteria for Adverse Events Version 4.0 | Up to 5 years | Twenty-nine eligible patients are included in the analysis. One patient was excluded due to ineligibility. | percent of pts with symptomatic ITH | NUMBER |
| SECONDARY | Pharmacokinetic Parameter of Cilengitide in Plasma: Volume of Central Compartment (Vc) | At baseline and 1, 3, and 6 hours after the first dose of cilengitide | All 18 patients consenting for pharmacokinetic study are included in this analysis. | L/m^2 | MEDIAN |
| SECONDARY | Pharmacokinetic Parameter of Cilengitide in Plasma: Elimination Rate Constant (Ke) | At baseline and 1, 3, and 6 hours after the first dose of cilengitide | All 18 patients consenting for pharmacokinetic study are included in this analysis. | hr^(-1) | MEDIAN |
| SECONDARY | Pharmacokinetic Parameter of Cilengitide in Plasma: Half-life (t1/2) | At baseline and 1, 3, and 6 hours after the first dose of cilengitide | All 18 patients consenting for pharmacokinetic study are included in this analysis. | hours | MEDIAN |
| SECONDARY | Pharmacokinetic Parameter of Cilengitide in Plasma: Systemic Clearance (Cl) | At baseline and 1, 3, and 6 hours after the first dose of cilengitide | All 18 patients consenting for pharmacokinetic study are included in this analysis. | L/hr/m^2 | MEDIAN |
| SECONDARY | Pharmacogenetic Polymorphism in Drug Transporter Gene ABCB1 and Relate to Cilengitide Disposition as Measured by AUC | At baseline | The analysis includes 12 eligible patients with both AUC data and ABCB1 Exon 26 data available. | Spearman's correlation | NUMBER |
| SECONDARY | Pharmacogenetic Polymorphism in Drug Transporter Gene ABCB1 and Relate to Cilengitide Disposition as Measured by Systemic Clearance | At Baseline | The analysis includes 12 eligible patients with both systemic clearance data and ABCB1 Exon 26 data available. | Spearman's Correlation | NUMBER |
| SECONDARY | Pharmacogenetic Polymorphism in Drug Transporter Gene ABCG2 and Relate to Cilengitide Disposition as Measured by AUC | At baseline | The analysis includes 12 eligible patients with both AUC data and ABCG2 Exon 5 data available. | Spearman's Correlation | NUMBER |
| SECONDARY | Pharmacogenetic Polymorphism in Drug Transporter Gene ABCG2 and Relate to Cilengitide Disposition as Measured by Systemic Clearance | At baseline | The analysis includes 12 eligible patients with both systemic clearance data and ABCG2 Exon 5 data available. | Spearman's Correlation | 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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