Trial · NCT00611325
Phase II Avastin + Bortezomib for Patients With Recurrent Malignant Glioma
NCT00611325, Phase 2, Completed, Duke University; results first posted 2014-02-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Avastin + Bortezomib for Patients With Recurrent Malignant Glioma. Trials, record NCT00611325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00611325
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Avastin + Bortezomib for Patients With Recurrent Malignant Glioma
- NCT number
- NCT00611325
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Glioblastoma, Gliosarcoma
- Interventions
- Avastin, Bortezomib
- First posted
- 2008-02-08
- Last updated
- 2014-03-12
- Results first posted
- 2014-02-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-month Progression-free Survival (PFS) | 6 months | Percentage of participants surviving six months from the initiation of treatment without progression of disease. PFS was defined as the time from the initiation of treatment to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration. |
| Secondary | Median Progression Free Survival (PFS) | Time in months from the start of study treatment to the date of first progression or death. Assessed up to 60 months. | Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. |
| Secondary | Median Overall Survival (OS) | Time in months from the start of study treatment to date of death due to any cause. Assessed up to 60 months. | Time in months from the start of study treatment to the date of death. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve. |
| Secondary | Radiographic Response Rate | 60 months | The percentage of participants with a complete or partial response at any assessment as determined by the Macdonald criteria. A confirmation of response was not required. Per Macdonald criteria, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions, no new lesions and stable or decreasing steroid dose. Objective response =CR+PR. Tumor assessments were done at baseline and at the end of each 6 week treatment cycle, and overall best response was recorded. |
| Secondary | Number of Patients With Grade 3 or Greater, Treatment-related, Non-hematologic Toxicities | 60 months | Number of patients with grade 3 or greater, treatment-related, non-hematologic toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6-month Progression-free Survival (PFS) | 6 months | percentage of participants | NUMBER | |
| SECONDARY | Median Progression Free Survival (PFS) | Time in months from the start of study treatment to the date of first progression or death. Assessed up to 60 months. | months | MEDIAN | |
| SECONDARY | Median Overall Survival (OS) | Time in months from the start of study treatment to date of death due to any cause. Assessed up to 60 months. | months | MEDIAN | |
| SECONDARY | Radiographic Response Rate | 60 months | percentage of participants | NUMBER | |
| SECONDARY | Number of Patients With Grade 3 or Greater, Treatment-related, Non-hematologic Toxicities | 60 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6-month Progression-free Survival (PFS) | EIAED | 25 | 95% Confidence Interval 9.0 to 41.0 | percentage of participants | |
| 6-month Progression-free Survival (PFS) | Non-EIAED | 28.6 | 95% Confidence Interval 11.9 to 45.3 | percentage of participants | |
| Median Progression Free Survival (PFS) | EIAED | 2 | 95% Confidence Interval 2 to 4 | months | |
| Median Progression Free Survival (PFS) | Non-EIAED | 2.5 | 95% Confidence Interval 1 to 4 | months | |
| Median Overall Survival (OS) | EIAED | 8 | 95% Confidence Interval 5 to 11 | months | |
| Median Overall Survival (OS) | Non-EIAED | 6 | 95% Confidence Interval 4 to 10 | months | |
| Radiographic Response Rate | EIAED | 7.1 | 95% Confidence Interval 0 to 16.6 | percentage of participants | |
| Radiographic Response Rate | Non-EIAED | 39.3 | 95% Confidence Interval 21.2 to 57.4 | percentage of participants | |
| Number of Patients With Grade 3 or Greater, Treatment-related, Non-hematologic Toxicities | EIAED | 27 | participants | ||
| Number of Patients With Grade 3 or Greater, Treatment-related, Non-hematologic Toxicities | Non-EIAED | 24 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EIAED | 28 | |
| Overall Study | STARTED | Non-EIAED | 28 | |
| Overall Study | COMPLETED | EIAED | 28 | |
| Overall Study | COMPLETED | Non-EIAED | 28 | |
| Overall Study | NOT COMPLETED | EIAED | 0 | |
| Overall Study | NOT COMPLETED | Non-EIAED | 0 |
Source ClinicalTrials.gov
Adverse events252
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 | Anemia | Blood and lymphatic system disorders | EIAED | 2 | 28 | |
| other | Anemia | Blood and lymphatic system disorders | Non-EIAED | 2 | 28 | |
| other | Blurred vision | Eye disorders | EIAED | 1 | 28 | |
| other | Blurred vision | Eye disorders | Non-EIAED | 3 | 28 | |
| other | Extraocular muscle paresis | Eye disorders | EIAED | 2 | 28 | |
| other | Extraocular muscle paresis | Eye disorders | Non-EIAED | 0 | 28 | |
| other | Eye disorders - Other, specify | Eye disorders | EIAED | 0 | 28 | |
| other | Eye disorders - Other, specify | Eye disorders | Non-EIAED | 3 | 28 | |
| other | Eye pain | Eye disorders | EIAED | 1 | 28 | |
| other | Eye pain | Eye disorders | Non-EIAED | 0 | 28 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EIAED | ||
| Total, all-cause mortality | Non-EIAED | ||
| Total, other adverse events | EIAED | 28 | 28 |
| Total, other adverse events | Non-EIAED | 28 | 28 |
| Total, serious adverse events | EIAED | 11 | 28 |
| Total, serious adverse events | Non-EIAED | 5 | 28 |
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 |
|---|---|
| EIAED vs Non-EIAED: Number of Patients With Grade 3 or Greater, Treatment-related, Non-hematologic Toxicities | Trial comparisons |
| EIAED vs Non-EIAED: 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/NCT00611325
GET https://conductscience.org/api/trials/v1/NCT00611325/events?page=2