Trial · NCT01380782
BIBF 1120 for Recurrent High-Grade Gliomas
NCT01380782, Phase 2, Completed, Patrick Y. Wen, MD; results first posted 2014-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BIBF 1120 for Recurrent High-Grade Gliomas. Trials, record NCT01380782. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01380782
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BIBF 1120 for Recurrent High-Grade Gliomas
- NCT number
- NCT01380782
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Patrick Y. Wen, MD
- Conditions
- Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma
- Interventions
- BIBF 1120
- First posted
- 2011-06-27
- Last updated
- 2014-08-18
- Results first posted
- 2014-08-18
- Limitations and caveats
The trial intended to enroll 14 participants onto Arm A GBM, but only 10 enrolled due to futility. In addition, 10 AG participants were to be enrolled onto each Arm as exploratory cohorts, but again due to futility only 4 enrolled onto Arm B.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-Month Progression Free Survival | Six months | To determine the efficacy of BIBF 1120 in bevacizumab-naive participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6). |
| Primary | 3-Month Progression Free Survival | 3 months | To determine the efficacy of BIBF 1120 in bevacizumab-treated participants with recurrent GBM as measured by 3-month progression free survival (PFS3). |
| Secondary | Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response | 2 years | Best radiographic response in both populations. There were no participants with partial or complete responses, so the results are being reported in the proportion of participants who experienced stable disease (SD) as their best response (as opposed to progressive disease). |
| Secondary | Overall Survival | 2 years | Overall survival in both populations |
| Secondary | Time-to-tumor Progression | 2 years | Time-to-tumor progression in both populations. |
| Secondary | Safety Profile as Summarized With Descriptive Statistics (Using Toxicity Data Gathered on Trial) | 2 years | Safety profile in both populations - as adverse events are posted separately in detail, these results will demonstrate serious adverse events (defined as grades 3-5) that were judged at least possibly related to Nintedanib (BIBF 1120). |
| Other | Exploratory Objective #1: Progression-free Survival at 3- and 6-months for Participants With Recurrent Anaplastic Gliomas (AG) | Arm A - 6 months; Arm B - 3 months | To explore the efficacy of BIBF 1120 in bevacizumab-naïve and bevacizumab-treated participants with recurrent anaplastic gliomas (AG) survival was assessed at 6 months for Arm A and 3 months for Arm B. |
| Other | Exploratory Objective #2: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Tumor Genotype and/or Expression Profile | 2 years | To explore the extent to which the tumor's genotype and expression profile correlate with outcome. |
| Other | Exploratory Objective #3: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Serum Angiogenic Peptides, Circulating Endothelial Cells, and/or Circulating Progenitor Cells | 2 years | To explore the correlation between serum angiogenic peptides, circulating endothelial cells, and circulating progenitor cells with response to therapy. |
| Other | Exploratory Objective #4: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Perfusion MRI, Diffusion MRI | 2 years | To explore the correlation between perfusion MRI, diffusion MRI and response to therapy. |
Source ClinicalTrials.gov
Outcomes10
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 | Six months | percentage of participants | NUMBER | |
| PRIMARY | 3-Month Progression Free Survival | 3 months | percentage of participants | NUMBER | |
| SECONDARY | Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response | 2 years | % of patients with best response SD | NUMBER | |
| SECONDARY | Overall Survival | 2 years | months | MEDIAN | |
| SECONDARY | Time-to-tumor Progression | 2 years | days | MEDIAN | |
| SECONDARY | Safety Profile as Summarized With Descriptive Statistics (Using Toxicity Data Gathered on Trial) | 2 years | number of incidents | NUMBER | |
| OTHER_PRE_SPECIFIED | Exploratory Objective #1: Progression-free Survival at 3- and 6-months for Participants With Recurrent Anaplastic Gliomas (AG) | Arm A - 6 months; Arm B - 3 months | percentage of participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Exploratory Objective #2: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Tumor Genotype and/or Expression Profile | 2 years | |||
| OTHER_PRE_SPECIFIED | Exploratory Objective #3: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Serum Angiogenic Peptides, Circulating Endothelial Cells, and/or Circulating Progenitor Cells | 2 years | |||
| OTHER_PRE_SPECIFIED | Exploratory Objective #4: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Perfusion MRI, Diffusion MRI | 2 years |
Source ClinicalTrials.gov
Results by group23
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 | Arm A (Bevacizumab-naive) - GBM | 0 | percentage of participants | ||
| 3-Month Progression Free Survival | Arm B (Bevacizumab Treated) - GBM | 0 | percentage of participants | ||
| Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response | Arm A (Bevacizumab-naive) - GBM | 33 | % of patients with best response SD | ||
| Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response | Arm A (Bevacizumab-naive) - AG | 40 | % of patients with best response SD | ||
| Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response | Arm B (Bevacizumab Treated) - GBM | 10 | % of patients with best response SD | ||
| Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response | Arm B (Bevacizumab Treated) - AG | 25 | % of patients with best response SD | ||
| Overall Survival | Arm A (Bevacizumab-naive) - GBM | 6.9 | 95% Confidence Interval 3.7 to 8.1 | months | |
| Overall Survival | Arm A (Bevacizumab-naive) - AG | 11.3 | 95% Confidence Interval 2.7 to 14.6 | months | |
| Overall Survival | Arm B (Bevacizumab Treated) - GBM | 2.6 | 95% Confidence Interval 1.0 to 6.9 | months | |
| Overall Survival | Arm B (Bevacizumab Treated) - AG | 7.3 | 95% Confidence Interval 1.4 to 18.1 | months |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Bevacizumab-naive) - GBM | 12 | |
| Overall Study | STARTED | Arm A (Bevacizumab-naive) - AG | 10 | |
| Overall Study | STARTED | Arm B (Bevacizumab Treated) - GBM | 11 | |
| Overall Study | STARTED | Arm B (Bevacizumab Treated) - AG | 4 | |
| Overall Study | COMPLETED | Arm A (Bevacizumab-naive) - GBM | 0 | |
| Overall Study | COMPLETED | Arm A (Bevacizumab-naive) - AG | 0 | |
| Overall Study | COMPLETED | Arm B (Bevacizumab Treated) - GBM | 0 | |
| Overall Study | COMPLETED | Arm B (Bevacizumab Treated) - AG | 0 | |
| Overall Study | NOT COMPLETED | Arm A (Bevacizumab-naive) - GBM | 12 | |
| Overall Study | NOT COMPLETED | Arm A (Bevacizumab-naive) - AG | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events164
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 pain | Gastrointestinal disorders | Arm A | 3 | 22 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B | 1 | 14 | 1 |
| other | Agitation | Psychiatric disorders | Arm A | 1 | 22 | 1 |
| other | Agitation | Psychiatric disorders | Arm B | 1 | 14 | 1 |
| other | Alanine aminotransferase increased | Investigations | Arm A | 4 | 22 | 10 |
| other | Alanine aminotransferase increased | Investigations | Arm B | 3 | 14 | 4 |
| other | Anorexia | Metabolism and nutrition disorders | Arm A | 2 | 22 | 3 |
| other | Anorexia | Metabolism and nutrition disorders | Arm B | 1 | 14 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Arm A | 4 | 22 | 9 |
| other | Aspartate aminotransferase increased | Investigations | Arm B | 0 | 14 | 0 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | ||
| Total, all-cause mortality | Arm B | ||
| Total, other adverse events | Arm A | 22 | 22 |
| Total, other adverse events | Arm B | 14 | 14 |
| Total, serious adverse events | Arm A | 8 | 22 |
| Total, serious adverse events | Arm B | 5 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25338318 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A vs Arm B: serious adverse events |
Source 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/NCT01380782
GET https://conductscience.org/api/trials/v1/NCT01380782/results?page=2