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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryProgression-free Survival18 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
SecondaryOverall Survival (OS)18 monthsMeasured from date of study entry to date of death due to any cause.
SecondaryObjective Response Rate18 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
SecondaryOverall Tolerability and Toxicity of High-dose Bevacizumab18 monthsNumber of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProgression-free Survival18 months (expected)monthsMEDIAN
SECONDARYOverall Survival (OS)18 monthsmonthsMEDIAN
SECONDARYObjective Response Rate18 monthsparticipantsNUMBER
SECONDARYOverall Tolerability and Toxicity of High-dose Bevacizumab18 monthsAll patients treated with Bevacizumab therapy were assessed for Grade 3/4 toxicitiesparticipantsNUMBER

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Progression-free SurvivalWeekly Avastin6.095% Confidence Interval 3.5 to 9.1months
Progression-free SurvivalBi-weekly Avastin5.795% Confidence Interval 3.6 to 9.2months
Overall Survival (OS)Weekly Avastin26.995% Confidence Interval 12.9 to NAmonths
Overall Survival (OS)Bi-weekly Avastin18.495% Confidence Interval 12.0 to 28.9months
Objective Response RateWeekly Avastin9participants
Objective Response RateBi-weekly Avastin6participants
Overall Tolerability and Toxicity of High-dose BevacizumabWeekly AvastinAnemia2participants
Overall Tolerability and Toxicity of High-dose BevacizumabBi-weekly AvastinAnemia5participants
Overall Tolerability and Toxicity of High-dose BevacizumabWeekly AvastinThrombocytopenia1participants
Overall Tolerability and Toxicity of High-dose BevacizumabBi-weekly AvastinThrombocytopenia0participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDWeekly Avastin58
Overall StudySTARTEDBi-weekly Avastin61
Overall StudyCOMPLETEDWeekly Avastin40
Overall StudyCOMPLETEDBi-weekly Avastin40
Overall StudyNOT COMPLETEDWeekly Avastin18
Overall StudyNOT COMPLETEDBi-weekly Avastin21

Adverse events180

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherFATIGUEGeneral disordersWeekly Avastin3758
otherFATIGUEGeneral disordersBi-weekly Avastin5061
otherPROTEINURIARenal and urinary disordersWeekly Avastin3458
otherPROTEINURIARenal and urinary disordersBi-weekly Avastin3961
otherNAUSEAGastrointestinal disordersWeekly Avastin2158
otherNAUSEAGastrointestinal disordersBi-weekly Avastin2261
otherAnorexiaMetabolism and nutrition disordersWeekly Avastin1458
otherAnorexiaMetabolism and nutrition disordersBi-weekly Avastin2461
otherHEADACHENervous system disordersWeekly Avastin1858
otherHEADACHENervous system disordersBi-weekly Avastin1761

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityWeekly Avastin
Total, all-cause mortalityBi-weekly Avastin
Total, other adverse eventsWeekly Avastin5858
Total, other adverse eventsBi-weekly Avastin6161
Total, serious adverse eventsWeekly Avastin3358
Total, serious adverse eventsBi-weekly Avastin3561

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.

ComparisonSource
Weekly Avastin vs Bi-weekly Avastin: Objective Response RateTrial comparisons
Weekly Avastin vs Bi-weekly Avastin: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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