Trial · NCT00371254
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Complete Response (CR) or Partial Response (PR) | Baseline to end of study drug therapy (up to 65 weeks). | All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Baseline to 16 weeks. | All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Baseline to 16 weeks | All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25 | Weeks 9, 17, and 25 | All treated participants | Proportion of Participants | NUMBER |
| SECONDARY | Mean Number of Weeks of Complete Response (CR) or Partial Response (PR) | Baseline to end of study drug therapy (up to 53.86 weeks) | Response-evaluable participants who achieved a complete response (CR) or partial response (PR) | weeks | MEAN |
| SECONDARY | Mean Plasma Concentration at Week 3 | At pre-dose and 1, 3, 6 and 12 hours after each dose administration | Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point. | nanograms (ng)/mL | MEAN |
| PRIMARY | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | Baseline to end of study drug therapy (up to 65 weeks). | All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug were included in this dataset. | percentage of participants | NUMBER |
| SECONDARY | Mean Plasma Concentration at Week 7 | At pre-dose and 1, 3, 6 and 12 hours after each dose administration | Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point. | nanograms (ng)/mL | MEAN |
| SECONDARY | Mean Change in Concentration of Collagen Type IV From Baseline | Baseline, Week 3 and Week 5 | Participants who were evaluable for pharmacodynamic analysis. | percentage of baseline | GEOMETRIC_MEAN |
| SECONDARY | Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline | Baseline, Week 3 and Week 5 | Participants who were evaluable for pharmacodynamic analysis. | percentage of baseline | GEOMETRIC_MEAN |
| SECONDARY | Percentage Change in Tumor Biomarkers | Baseline | All treated participants who were evaluable for the analysis. These data for tumor markers were integrated with those from other studies and are not reportable for this study alone. | percentage | MEDIAN |
| SECONDARY | Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity | Baseline | All treated participants who were evaluable for the analysis. These data for pharmacogenomic analyses were integrated with those from other studies and are not reportable for this study alone. | log2 scale (unitless) | NUMBER |
| SECONDARY | Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs) | From start of study drug therapy up to 30 days after the last dose. | All treated participants. | participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs | From start of study drug therapy up to 30 days after the last dose. | All treated participants | participants | NUMBER |
| SECONDARY | Most Frequent Drug-related Adverse Events (AEs) | From start of study drug therapy up to 30 days after the last dose. | All treated participants | participants | NUMBER |
| SECONDARY | Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements | Throughout study, from start of study drug therapy up to 30 days after the last dose. | All treated participants | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT) | Throughout study, from start of study drug therapy up to 30 days after the last dose. | All treated participants | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT) | Throughout study, from start of study drug therapy up to 30 days after the last dose. | All treated participants. | Participants | NUMBER |
| SECONDARY | Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase | Throughout study, from start of study drug therapy up to 30 days after the last dose. | All treated participants | participants | NUMBER |
| SECONDARY | Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium | Throughout study, from start of study drug therapy up to 30 days after the last dose. | All treated participants | participants | 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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