Trial · NCT00612430
Ph II Bevacizumab + Etoposide for Pts w Recurrent MG
NCT00612430, Phase 2, Completed, Duke University; results first posted 2013-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ph II Bevacizumab + Etoposide for Pts w Recurrent MG. Trials, record NCT00612430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00612430
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph II Bevacizumab + Etoposide for Pts w Recurrent MG
- NCT number
- NCT00612430
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Glioblastoma, Gliosarcoma
- Interventions
- Bevacizumab and Etoposide
- First posted
- 2008-02-11
- Last updated
- 2013-08-12
- Results first posted
- 2013-07-26
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 start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression was defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. |
| Secondary | Objective Response Rate | 2 years | The percentage of participants with complete or partial response as determined by the following criteria: complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination; partial response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination. A confirmation of response was not required. |
| Secondary | Safety of Study Treatment Regimen | 2 years | Number of participants experiencing a non-hematologic toxicity ≥ grade 3 that was possibly, probably, or definitely related to study treatment. |
| Secondary | Median Progression-Free Survival | Patients were followed for a median of 91.4 weeks | Time in weeks from the start of study treatment to the date of first progression, or to death due to any cause. 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) | median of 91.4 weeks | Time in weeks from the start of study treatment to date of death due to any cause. 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. |
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 | Objective Response Rate | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Safety of Study Treatment Regimen | 2 years | participants | NUMBER | |
| SECONDARY | Median Progression-Free Survival | Patients were followed for a median of 91.4 weeks | weeks | MEDIAN | |
| SECONDARY | Median Overall Survival (OS) | median of 91.4 weeks | weeks | MEDIAN |
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) | Grade III | 41 | 95% Confidence Interval 24 to 57 | percentage of participants | |
| 6 Month Progression-Free Survival (PFS) | Grade IV | 44 | 95% Confidence Interval 26 to 62 | percentage of participants | |
| Objective Response Rate | Grade III | 24 | percentage of participants | ||
| Objective Response Rate | Grade IV | 23 | percentage of participants | ||
| Safety of Study Treatment Regimen | Grade III | 9 | participants | ||
| Safety of Study Treatment Regimen | Grade IV | 13 | participants | ||
| Median Progression-Free Survival | Grade III | 24 | 95% Confidence Interval 16 to 33 | weeks | |
| Median Progression-Free Survival | Grade IV | 18 | 95% Confidence Interval 13 to 40 | weeks | |
| Median Overall Survival (OS) | Grade III | 63.1 | 95% Confidence Interval 36 to NA | weeks | |
| Median Overall Survival (OS) | Grade IV | 46.4 | 95% Confidence Interval 25 to 70 | weeks |
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 | Grade III | 32 | |
| Overall Study | STARTED | Grade IV | 27 | |
| Overall Study | COMPLETED | Grade III | 32 | |
| Overall Study | COMPLETED | Grade IV | 27 | |
| Overall Study | NOT COMPLETED | Grade III | 0 | |
| Overall Study | NOT COMPLETED | Grade IV | 0 |
Source ClinicalTrials.gov
Adverse events316
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 | Grade III | 10 | 32 | |
| other | Anemia | Blood and lymphatic system disorders | Grade IV | 19 | 27 | |
| other | Cardiac disorders - Other, specify: S1-S2 with grade II/IV murmur | Cardiac disorders | Grade III | 0 | 32 | |
| other | Cardiac disorders - Other, specify: S1-S2 with grade II/IV murmur | Cardiac disorders | Grade IV | 1 | 27 | |
| other | Cardiac disorders - Other, specify: Variable Heart Rate | Cardiac disorders | Grade III | 1 | 32 | |
| other | Cardiac disorders - Other, specify: Variable Heart Rate | Cardiac disorders | Grade IV | 0 | 27 | |
| other | Cardiac disorders - Other, specify: Angina | Cardiac disorders | Grade III | 1 | 32 | |
| other | Cardiac disorders - Other, specify: Angina | Cardiac disorders | Grade IV | 0 | 27 | |
| other | Hearing impaired | Ear and labyrinth disorders | Grade III | 2 | 32 | |
| other | Hearing impaired | Ear and labyrinth disorders | Grade IV | 0 | 27 |
1 to 10 of 316Source ClinicalTrials.gov
See all 316 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Grade III | ||
| Total, all-cause mortality | Grade IV | ||
| Total, other adverse events | Grade III | 31 | 32 |
| Total, other adverse events | Grade IV | 27 | 27 |
| Total, serious adverse events | Grade III | 2 | 32 |
| Total, serious adverse events | Grade IV | 3 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19920819 | DERIVED |
Source PubMed
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 |
|---|---|
| Grade III vs Grade IV: Safety of Study Treatment Regimen | Trial comparisons |
| Grade III vs Grade IV: 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/NCT00612430
GET https://conductscience.org/api/trials/v1/NCT00612430/events?page=2