Trial · NCT00455975
High-dose Bevacizumab in Advanced Renal Carcinoma Patients
NCT00455975, Phase 2, Completed, SCRI Development Innovations, LLC; results first posted 2014-12-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High-dose Bevacizumab in Advanced Renal Carcinoma Patients. Trials, record NCT00455975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00455975
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High-dose Bevacizumab in Advanced Renal Carcinoma Patients
- NCT number
- NCT00455975
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 119 participants, actual
- Lead sponsor
- SCRI Development Innovations, LLC
- Conditions
- Renal Cancer, Kidney Cancer
- Interventions
- Bevacizumab
- First posted
- 2007-04-04
- Last updated
- 2014-12-22
- Results first posted
- 2014-12-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | 18 months (expected) | Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Overall Survival (OS) | 18 months | Measured from date of study entry to date of death due to any cause. |
| Secondary | Objective Response Rate | 18 months | The number of patients with observed complete response \[CR\] or partial response \[PR\]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR |
| Secondary | Overall Tolerability and Toxicity of High-dose Bevacizumab | 18 months | Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | 18 months (expected) | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | 18 months | months | MEDIAN | |
| SECONDARY | Objective Response Rate | 18 months | participants | NUMBER | |
| SECONDARY | Overall Tolerability and Toxicity of High-dose Bevacizumab | 18 months | All patients treated with Bevacizumab therapy were assessed for Grade 3/4 toxicities | participants | NUMBER |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Weekly Avastin | 6.0 | 95% Confidence Interval 3.5 to 9.1 | months | |
| Progression-free Survival | Bi-weekly Avastin | 5.7 | 95% Confidence Interval 3.6 to 9.2 | months | |
| Overall Survival (OS) | Weekly Avastin | 26.9 | 95% Confidence Interval 12.9 to NA | months | |
| Overall Survival (OS) | Bi-weekly Avastin | 18.4 | 95% Confidence Interval 12.0 to 28.9 | months | |
| Objective Response Rate | Weekly Avastin | 9 | participants | ||
| Objective Response Rate | Bi-weekly Avastin | 6 | participants | ||
| Overall Tolerability and Toxicity of High-dose Bevacizumab | Weekly Avastin | Anemia | 2 | participants | |
| Overall Tolerability and Toxicity of High-dose Bevacizumab | Bi-weekly Avastin | Anemia | 5 | participants | |
| Overall Tolerability and Toxicity of High-dose Bevacizumab | Weekly Avastin | Thrombocytopenia | 1 | participants | |
| Overall Tolerability and Toxicity of High-dose Bevacizumab | Bi-weekly Avastin | Thrombocytopenia | 0 | participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Weekly Avastin | 58 | |
| Overall Study | STARTED | Bi-weekly Avastin | 61 | |
| Overall Study | COMPLETED | Weekly Avastin | 40 | |
| Overall Study | COMPLETED | Bi-weekly Avastin | 40 | |
| Overall Study | NOT COMPLETED | Weekly Avastin | 18 | |
| Overall Study | NOT COMPLETED | Bi-weekly Avastin | 21 |
Source ClinicalTrials.gov
Adverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | FATIGUE | General disorders | Weekly Avastin | 37 | 58 | |
| other | FATIGUE | General disorders | Bi-weekly Avastin | 50 | 61 | |
| other | PROTEINURIA | Renal and urinary disorders | Weekly Avastin | 34 | 58 | |
| other | PROTEINURIA | Renal and urinary disorders | Bi-weekly Avastin | 39 | 61 | |
| other | NAUSEA | Gastrointestinal disorders | Weekly Avastin | 21 | 58 | |
| other | NAUSEA | Gastrointestinal disorders | Bi-weekly Avastin | 22 | 61 | |
| other | Anorexia | Metabolism and nutrition disorders | Weekly Avastin | 14 | 58 | |
| other | Anorexia | Metabolism and nutrition disorders | Bi-weekly Avastin | 24 | 61 | |
| other | HEADACHE | Nervous system disorders | Weekly Avastin | 18 | 58 | |
| other | HEADACHE | Nervous system disorders | Bi-weekly Avastin | 17 | 61 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Weekly Avastin | ||
| Total, all-cause mortality | Bi-weekly Avastin | ||
| Total, other adverse events | Weekly Avastin | 58 | 58 |
| Total, other adverse events | Bi-weekly Avastin | 61 | 61 |
| Total, serious adverse events | Weekly Avastin | 33 | 58 |
| Total, serious adverse events | Bi-weekly Avastin | 35 | 61 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Weekly Avastin vs Bi-weekly Avastin: Objective Response Rate | Trial comparisons |
| Weekly Avastin vs Bi-weekly Avastin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00455975
GET https://conductscience.org/api/trials/v1/NCT00455975/results?page=2