Trial · NCT01266031
Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma
NCT01266031, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma. Trials, record NCT01266031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01266031
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma
- NCT number
- NCT01266031
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 96 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Malignant Glioma, Recurrent Glioblastoma
- Interventions
- vorinostat, bevacizumab
- First posted
- 2010-12-24
- Last updated
- 2018-07-31
- Results first posted
- 2016-09-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) at 6 Months | Baseline until disease progression or death due to any cause, up to six months | PFS is time measured in months to disease progression as assessed at six months from participant registration. Assessments continue every 8 weeks up to 28 days after last dose (follow-up), anticipated trial length one year. Participants must be assessed at least 4 weeks after surgery to begin treatment in the adaptive randomized Phase 2 portion of the trial. PFS in participants in the surgical arm determined from the date of randomization to the treatment arms and not from the date of registration in the trial. Study outcome measure period ended June 2015. |
| Primary | Maximum Tolerated Dose (MTD) of Oral Vorinostat Used With Bevacizumab | 28 day, cycle 1 | MTD defined as the dose level at which 1/6 patients experience dose limiting toxicity (DLT), using conventional Phase I design where the MTD was selected using a 3+3 accrual design at each dose level until MTD was determined. Toxicities will be graded according to the Common Terminology Criteria for Adverse events (CTCAE) Version 4.0. |
| Secondary | Time to Progression (TTP) | 3, 6, and 12 months from patient registration | Progression defined by the Modified MacDonald criteria is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer). |
| Secondary | Overall Survival (OS) | up to 30 months. | OS was computed using the number of months from the date of randomization to the date of death, up to 30 months. Participants still alive were censored at the last follow-up date. |
| Secondary | Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Vascular Endothelial Growth Factor (VEGF), Placental Growth Factor (PIGF), and Basic Fibroblast Growth Factor (bFGF) | Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion) | About 5cc of blood was collected to measure plasma angiogenic proteins vascular endothelial growth factor (VEGF), placental growth factor (PIGF), and basic fibroblast growth factor (bFGF) by enzyme-linked immunosorbent assay (ELISA). |
| Secondary | Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Stromal Cell-derived Factor α (SDF1α), and Angiopoietin 1 (Ang 1) and 2 (Ang 2) by Enzyme-linked Immunosorbent Assay (ELISA) | Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion) | About 5cc of blood was collected to measure plasma angiogenic proteins stromal cell-derived factor α (SDF1α), angiopoietin 1 and 2 by enzyme-linked immunosorbent assay (ELISA). |
| Secondary | Percentage of Patients Rating Their Symptoms to be 7 or Greater on a 0-10 Scale Using the Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Self Reporting Tool | Baseline, week 4, week 8, and end of therapy, approximately week 52 (cycle 12) | Percentage of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is "not present" and 10 is "as bad as you can imagine. All patients with at least one valid questionnaire will be included in the analyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures. |
| Secondary | Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool | Baseline, week 4 (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12) | Overall mean severity of 22 symptoms. Symptoms are rated 0-10, zero is "not present" and 10 is "as bad as you can imagine". All patients with at least one valid questionnaire will be included in the analyses. |
| Secondary | Mean Symptom Interference at the Time of Clinical Evaluation | Baseline, (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12) | Overall mean interference severity of 6 interference items. Interference is rated 0-10, zero is "did not interfere" and 10 is "as bad as you can imagine". All patients with at least one valid questionnaire will be included in the analyses. |
| Secondary | Radiological Response | End of therapy, approximately | Magnetic resonance imaging (MRI) and contrast-enhanced (CE) MRI was used to evaluate tumor response. Response is defined by the Modified MacDonald criteria. Complete Response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. Partial Response, Non-Measurable (PRNM) is not applicable. Stable/No Response does not qualify for CR, PR or progression. Progression is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) at 6 Months | Baseline until disease progression or death due to any cause, up to six months | Months | MEDIAN | |
| PRIMARY | Maximum Tolerated Dose (MTD) of Oral Vorinostat Used With Bevacizumab | 28 day, cycle 1 | mg/day | NUMBER | |
| SECONDARY | Time to Progression (TTP) | 3, 6, and 12 months from patient registration | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | up to 30 months. | Months | MEDIAN | |
| SECONDARY | Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Vascular Endothelial Growth Factor (VEGF), Placental Growth Factor (PIGF), and Basic Fibroblast Growth Factor (bFGF) | Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion) | This outcome measure was not done. A few samples were collected and stored. However, the correlative biology was predicated on adequate acquisition of tumor tissue and funding. unfortunately, we were unable to obtain funding to perform this aspect (i.e. analysis) of the study. | ||
| SECONDARY | Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Stromal Cell-derived Factor α (SDF1α), and Angiopoietin 1 (Ang 1) and 2 (Ang 2) by Enzyme-linked Immunosorbent Assay (ELISA) | Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion) | This outcome measure was not done. A few samples were collected and stored. However, the correlative biology was predicated on adequate acquisition of tumor tissue and funding. unfortunately, we were unable to obtain funding to perform this aspect (i.e. analysis) of the study. | ||
| SECONDARY | Percentage of Patients Rating Their Symptoms to be 7 or Greater on a 0-10 Scale Using the Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Self Reporting Tool | Baseline, week 4, week 8, and end of therapy, approximately week 52 (cycle 12) | Reason outcome measure #7 is not done per arm/group is it was intentionally not completed due to negative findings of the study's primary outcomes. | percentage of of participants | NUMBER |
| SECONDARY | Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool | Baseline, week 4 (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12) | Overall analysis was done but not done by treatment arm/group. | score on a scale | MEAN |
| SECONDARY | Mean Symptom Interference at the Time of Clinical Evaluation | Baseline, (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12) | Overall analysis was done but not done by treatment arm/group. | score on a scale | MEAN |
| SECONDARY | Radiological Response | End of therapy, approximately | This outcome measure was not done. We collected radiological response data provided by the local physician at time points per protocol. At the end of the study, the plan was to send all MRI discs to one radiologist for central review to confirm responses. With only limited funding, and negative findings, the PI decided to not pursue this outcome. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) at 6 Months | Bevacizumab | 0.29 | 95% Confidence Interval 0.15 to 0.45 | Months | |
| Progression Free Survival (PFS) at 6 Months | Bevacizumab + Vorinostat 400 mg | 0.23 | 95% Confidence Interval 0.12 to 0.36 | Months | |
| Maximum Tolerated Dose (MTD) of Oral Vorinostat Used With Bevacizumab | Vorinostat + Bevacizumab | 400 | mg/day | ||
| Time to Progression (TTP) | Phase II: Bevacizumab | Overall TTP | 4.07 | 95% Confidence Interval 1.94 to 5.88 | Months |
| Time to Progression (TTP) | Phase II: Bevacizumab + Vorinostat 400 mg | Overall TTP | 3.71 | 95% Confidence Interval 2.73 to 4.63 | Months |
| Time to Progression (TTP) | Phase II: Bevacizumab | 3 months | 0.59 | 95% Confidence Interval 0.41 to 0.73 | Months |
| Time to Progression (TTP) | Phase II: Bevacizumab + Vorinostat 400 mg | 3 months | 0.62 | 95% Confidence Interval 0.46 to 0.74 | Months |
| Time to Progression (TTP) | Phase II: Bevacizumab | 6 months | 0.29 | 95% Confidence Interval 0.15 to 0.45 | Months |
| Time to Progression (TTP) | Phase II: Bevacizumab + Vorinostat 400 mg | 6 months | 0.28 | 95% Confidence Interval 0.15 to 0.42 | Months |
| Time to Progression (TTP) | Phase II: Bevacizumab | 12 months | 0.06 | 95% Confidence Interval 0.01 to 0.19 | Months |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vorinostat + Bevacizumab | 6 | |
| Overall Study | STARTED | Bevacizumab | 41 | |
| Overall Study | STARTED | Bevacizumab + Vorinostat 400 mg | 49 | |
| Overall Study | COMPLETED | Vorinostat + Bevacizumab | 6 | |
| Overall Study | COMPLETED | Bevacizumab | 38 | |
| Overall Study | COMPLETED | Bevacizumab + Vorinostat 400 mg | 47 | |
| Overall Study | NOT COMPLETED | Vorinostat + Bevacizumab | 0 | |
| Overall Study | NOT COMPLETED | Bevacizumab | 3 | |
| Overall Study | NOT COMPLETED | Bevacizumab + Vorinostat 400 mg | 2 |
Source ClinicalTrials.gov
Adverse events747
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 | Abdominal distension | Gastrointestinal disorders | Phase I: Vorinostat + Bevacizumab | 0 | 6 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Phase II: Bevacizumab | 1 | 38 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Phase II: Bevacizumab + Vorinostat 400 mg | 0 | 47 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Phase I: Vorinostat + Bevacizumab | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Phase II: Bevacizumab | 4 | 38 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Phase II: Bevacizumab + Vorinostat 400 mg | 2 | 47 | 4 |
| other | Ear and labyrinth disorders, Other, specify | Ear and labyrinth disorders | Phase I: Vorinostat + Bevacizumab | 0 | 6 | 0 |
| other | Ear and labyrinth disorders, Other, specify | Ear and labyrinth disorders | Phase II: Bevacizumab | 0 | 38 | 0 |
| other | Ear and labyrinth disorders, Other, specify | Ear and labyrinth disorders | Phase II: Bevacizumab + Vorinostat 400 mg | 1 | 47 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Phase I: Vorinostat + Bevacizumab | 0 | 6 | 0 |
1 to 10 of 747Source ClinicalTrials.gov
See all 747 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: Vorinostat + Bevacizumab | 0 | 6 |
| Total, all-cause mortality | Phase II: Bevacizumab | 0 | 38 |
| Total, all-cause mortality | Phase II: Bevacizumab + Vorinostat 400 mg | 1 | 47 |
| Total, other adverse events | Phase I: Vorinostat + Bevacizumab | 6 | 6 |
| Total, other adverse events | Phase II: Bevacizumab | 36 | 38 |
| Total, other adverse events | Phase II: Bevacizumab + Vorinostat 400 mg | 43 | 47 |
| Total, serious adverse events | Phase I: Vorinostat + Bevacizumab | 0 | 6 |
| Total, serious adverse events | Phase II: Bevacizumab | 10 | 38 |
| Total, serious adverse events | Phase II: Bevacizumab + Vorinostat 400 mg | 14 | 47 |
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
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