Trial · NCT02157103
A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma
NCT02157103, Phase 2, Completed, Emory University; results first posted 2018-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma. Trials, record NCT02157103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02157103
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma
- NCT number
- NCT02157103
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Glioblastoma
- Interventions
- Bevacizumab 25 mg in 1 ml subcutaneously daily
- First posted
- 2014-06-05
- Last updated
- 2018-05-17
- Results first posted
- 2018-04-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Change in Peritumoral Enhancement/Edema | 1 cycle (3 weeks) | To describe MRI response regarding edema and enhancement of glioblastoma and radiation-related brain enhancement when treated with subcutaneous bevacizumab daily. The therapeutic benefit of bevacizumab as regards glioblastoma multiforme (GBM) is largely due to the normalization of brain vasculature. This normalization appears on contrast-enhanced MRI as a reduction in enhancement and reduction in edema. For purposes of this study, any reduction in enhancement/edema by 25% or more will be considered a response. |
| Secondary | Number of Toxicities Reported in Study Participants | During first 3 weeks of study | Subcutaneous bevacizumab may have toxicities unique to the subcutaneous administration and not seen with intravenous bevacizumab. During the first 3 weeks we will watch for such toxicities. Toxicities will be described and graded using the Common Toxicity Criteria for Adverse Effects (CTCAE) v3. |
| Secondary | Number of Participants With Change in Edema After Conversion From Study Treatment to Intravenous Bevacizumab | Within 2 months of starting intravenous bevacizumab | Participants may switch from subcutaneous bevacizumab on study to standard of care intravenous bevacizumab. In these participants, we will measure decrease of edema after this switch. A further decrease in edema after making this switch would suggest intravenous to be superior to subcutaneous as regards decreasing edema. The therapeutic benefit of bevacizumab as regards GBM is largely due to the normalization of brain vasculature. This normalization appears on contrast-enhanced MRI as a reduction in edema. For purposes of this study, any reduction in edema by 25% or more will be considered a response. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Change in Peritumoral Enhancement/Edema | 1 cycle (3 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Toxicities Reported in Study Participants | During first 3 weeks of study | Toxicities | NUMBER | |
| SECONDARY | Number of Participants With Change in Edema After Conversion From Study Treatment to Intravenous Bevacizumab | Within 2 months of starting intravenous bevacizumab | One patient did not switch to standard of care intravenous bevacizumab. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Change in Peritumoral Enhancement/Edema | Bevacizumab | No change in edema | 1 | Participants | |
| Number of Participants With Change in Peritumoral Enhancement/Edema | Bevacizumab | Decrease in radiation-related edema | 2 | Participants | |
| Number of Toxicities Reported in Study Participants | Bevacizumab | 0 | Toxicities | ||
| Number of Participants With Change in Edema After Conversion From Study Treatment to Intravenous Bevacizumab | Bevacizumab | No change in edema after switch | 1 | Participants | |
| Number of Participants With Change in Edema After Conversion From Study Treatment to Intravenous Bevacizumab | Bevacizumab | Decrease of edema after switch | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab | 3 | |
| Overall Study | COMPLETED | Bevacizumab | 3 | |
| Overall Study | NOT COMPLETED | Bevacizumab | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Bruising | Skin and subcutaneous tissue disorders | Bevacizumab | 2 | 3 | |
| other | Headache | Nervous system disorders | Bevacizumab | 1 | 3 | |
| other | Nausea | Gastrointestinal disorders | Bevacizumab | 1 | 3 | |
| serious | Low platelets | Blood and lymphatic system disorders | Bevacizumab | 1 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab | 0 | 3 |
| Total, other adverse events | Bevacizumab | 2 | 3 |
| Total, serious adverse events | Bevacizumab | 1 | 3 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02157103
GET https://conductscience.org/api/trials/v1/NCT02157103/registered