Trial · NCT00892177
Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme
NCT00892177, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme. Trials, record NCT00892177. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00892177
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme
- NCT number
- NCT00892177
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 144 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Glioblastoma Multiforme
- Interventions
- bevacizumab, dasatinib, placebo
- First posted
- 2009-05-04
- Last updated
- 2019-10-21
- Results first posted
- 2017-06-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I) | 14 days | The Maximum Tolerated Dose (MTD) will be based on the assessment of dose-limiting toxicities (DLT) during the first 4 weeks of treatment only (i.e., following the first 2 treatment cycles), and will be defined as the dose at which fewer than one-third of patients experience a DLT to study treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with the next higher dose having at least 2 out of 3 or 2 out of 6 patients encountering DLT.\> Three patients will be treated at each dose level, and can be enrolled simultaneously. If one DLT is encountered, an additional 3 patients will be added to that dose level. If at any point two DLTs are encountered within a given dose level, then the MTD has been exceeded and if only three patients have been treated at the next lower dose three more patients are treated at the next lower dose. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section. |
| Primary | Progression-free Survival at 6 Months (PFS6) (Phase II) | 6 months | The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation (PFS6). All eligible consented patients that received treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. PFS6 is defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS6 will be estimated as the number of evaluable patients progression free and still alive at 6 months divided by the total number of evaluable patients. The confidence interval will be calculated according to the Clopper-Pearson Method. |
| Secondary | Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II) | Up to 3 years | Adverse events were collected systematically at the end of each cycle and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. Events are scored as: 1="Mild symptoms", 2= "Moderate", 3="Severe", 4="Life-threatening", and 5="Death". The number of patients reporting a grade 3 or higher event regardless of attribution are summarized here. A complete list of all adverse events reported during treatment can be found in the Adverse Events Section. |
| Secondary | Overall Survival (Phase II) | Up to 3 years | Survival time is defined to be the length of time from start of study therapy to death due to any cause. All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable for estimation of the survival distribution. The distribution of overall survival for both arms of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests. |
| Secondary | Time-to-disease Progression (Phase II) | Up to 3 years | Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy or date last known to be alive, whichever is later. Patients who are still alive and have not progressed will be censored for progression at the time of the last tumor assessment. Patients who experience major treatment violations will be censored for progression on the date the treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method. |
| Secondary | Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II) | Baseline to cycle 10 (20 weeks). | FACT-Br questionnaires were used to assess QOL at every other cycle of treatment (prior to cycles 3, 5, 7, etc.). FACT-Br includes 50 questions used to assess patients' self-assessment in 4 broad categories: Physical, Social/Family, Emotional, and Function Well-being. Scores range from 0="Not at all", 1="A little bit", 2="Somewhat", 3="Quite a bit", 4="Very Much". Higher scores can be interpreted as having higher quality of life. The scores for all 50 questions were summed to give a total score per patient per cycle. Therefore the possible range is from 0 to 200. Below is the reported mean and standard deviation for patients at baseline and during cycles 2, 4, 6, 8, and 10. |
| Secondary | Objective Response (Phase II) | Up to 3 years | Objective response to treatment will be determined by the results of neurological exam and the MRI and/or CT measurement of the tumor at each evaluation as is used for all NCCTG neuro-oncology trials. The percentage of patients in each response category will be summarized, 95% confidence intervals calculated, and rates between the 2 arms will be compared using a Fisher's Exact test. For bi-dimensionally measurable disease, CR: total disappearance of all tumor and that patients be on no corticosteroids or on only adrenal replacement maintenance; PR: ≥ 50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions, and stable or decreasing steroid dosing; PD: \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions; REGR: unequivocal reduction in extent of contrast-enhancement, or a decrease in mass effect, no new lesions (for evaluable disease); SD: failure to qualify for CR, PR,REGR or PD. |
Source ClinicalTrials.gov
Outcomes7
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 Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I) | 14 days | Adverse event information is available for 4 patients on study 1 dose level 1 (with 1 being a MTD replacement due to disease progression prior to completing cycles 1 and 2). | participants who developed DLTs | NUMBER |
| PRIMARY | Progression-free Survival at 6 Months (PFS6) (Phase II) | 6 months | All patients that received treatment and were eligible for assessment were included in this analysis. | proportion of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II) | Up to 3 years | All Phase II patients treated and evaluated for adverse events are included in this Phase II endpoint analysis. | participants | NUMBER |
| SECONDARY | Overall Survival (Phase II) | Up to 3 years | All eligible Phase II patients are included in this Phase II endpoint analysis. | months | MEDIAN |
| SECONDARY | Time-to-disease Progression (Phase II) | Up to 3 years | All eligible Phase II patients are included in this Phase II endpoint analysis. | months | MEDIAN |
| SECONDARY | Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II) | Baseline to cycle 10 (20 weeks). | All Phase II patients that began treatment and submitted at least one FACT-Br questionnaire were included in this analysis. | units on a scale | MEAN |
| SECONDARY | Objective Response (Phase II) | Up to 3 years | All eligible Phase II patients are included in this Phase II endpoint analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group41
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 Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I) | Phase I : Dose Level 0 | 0 | participants who developed DLTs | ||
| Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I) | Phase I : Dose Level 1 | 0 | participants who developed DLTs | ||
| Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I) | Phase I : Dose Level 2 | 0 | participants who developed DLTs | ||
| Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I) | Phase I : Dose Level 3 Cohort 1 | 0 | participants who developed DLTs | ||
| Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I) | Phase I: Dose Level 3 Cohort 2 | 1 | participants who developed DLTs | ||
| Progression-free Survival at 6 Months (PFS6) (Phase II) | Phase II: Arm A (Bevacizumab + Dasatinib) | 0.29 | 90% Confidence Interval 0.19 to 0.39 | proportion of participants | |
| Progression-free Survival at 6 Months (PFS6) (Phase II) | Phase II: Arm B (Bevacizumab + Placebo) | 0.18 | 90% Confidence Interval 0.08 to 0.34 | proportion of participants | |
| Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II) | Phase II: Arm A (Bevacizumab + Dasatinib) | Grade 3 Adverse Event | 42 | participants | |
| Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II) | Phase II: Arm B (Bevacizumab + Placebo) | Grade 3 Adverse Event | 23 | participants | |
| Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II) | Phase II: Arm A (Bevacizumab + Dasatinib) | Grade 4 Adverse Event | 8 | participants |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I: Dose Level 0 | STARTED | Phase I: Dose Level 0 | 3 | |
| Phase I: Dose Level 0 | STARTED | Phase I: Dose Level 1 | 0 | |
| Phase I: Dose Level 0 | STARTED | Phase I: Dose Level 2 | 0 | |
| Phase I: Dose Level 0 | STARTED | Phase I: Dose Level 3 | 0 | |
| Phase I: Dose Level 0 | STARTED | Phase II: Arm A (Bevacizumab + Dasatinib) | 0 | |
| Phase I: Dose Level 0 | STARTED | Phase II: Arm B (Bevacizumab + Placebo) | 0 | |
| Phase I: Dose Level 0 | COMPLETED | Phase I: Dose Level 0 | 3 | |
| Phase I: Dose Level 0 | COMPLETED | Phase I: Dose Level 1 | 0 | |
| Phase I: Dose Level 0 | COMPLETED | Phase I: Dose Level 2 | 0 | |
| Phase I: Dose Level 0 | COMPLETED | Phase I: Dose Level 3 | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events1,338
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Phase I: Dose Level 0 | 3 | 3 | 28 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase I: Dose Level 1 | 2 | 4 | 24 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase I: Dose Level 2 | 2 | 3 | 22 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase I: Dose Level 3 | 5 | 6 | 20 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase II: Arm A (Bevacizumab + Dasatinib) | 67 | 84 | 432 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase II: Arm B (Bevacizumab + Placebo) | 14 | 39 | 38 |
| other | Atrial fibrillation | Cardiac disorders | Phase I: Dose Level 0 | 0 | 3 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Phase I: Dose Level 1 | 0 | 4 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Phase I: Dose Level 2 | 0 | 3 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Phase I: Dose Level 3 | 0 | 6 | 0 |
1 to 10 of 1,338Source ClinicalTrials.gov
See all 1,338 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: Dose Level 0 | ||
| Total, all-cause mortality | Phase I: Dose Level 1 | ||
| Total, all-cause mortality | Phase I: Dose Level 2 | ||
| Total, all-cause mortality | Phase I: Dose Level 3 | ||
| Total, all-cause mortality | Phase II: Arm A (Bevacizumab + Dasatinib) | ||
| Total, all-cause mortality | Phase II: Arm B (Bevacizumab + Placebo) | ||
| Total, other adverse events | Phase I: Dose Level 0 | 3 | 3 |
| Total, other adverse events | Phase I: Dose Level 1 | 4 | 4 |
| Total, other adverse events | Phase I: Dose Level 2 | 3 | 3 |
| Total, other adverse events | Phase I: Dose Level 3 | 6 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31290996 | 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 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/NCT00892177
GET https://conductscience.org/api/trials/v1/NCT00892177/results?page=2