Trial · NCT00869401
Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00869401, Phase 1, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-05-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme. Trials, record NCT00869401. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00869401
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- NCT number
- NCT00869401
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 217 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- dasatinib, temozolomide, placebo, radiation therapy
- First posted
- 2009-03-26
- Last updated
- 2020-02-13
- Results first posted
- 2017-05-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Up to 5 years post treatment | Overall survival (OS) is the primary endpoint and is defined as the time from study registration to time of death due to any cause. All patients who meet the eligibility criteria, have signed a consent form, and have received at least one dose of the regimens will be considered evaluable. Patients who are lost to follow-up will be censored at the date of their last follow-up. Patients still alive at the time of analysis will be censored. Only Phase II was evaluated for survival |
| Primary | The Number of Dose Limiting Toxicities(DLT) in Order to Determine Maximum Tolerable Dose(MTD) of Dasatinib Combined With Radiation and Temozolomide in This Patient Population. | Every cycle from first dose to end of rest period prior cycle 3 | Doselimiting toxicity will be defined as: Adverse event at least possibly related to the study medication. All by CTCAE v3.0 criteria: Greater than or equal to grade 3: diarrhea or skin rash or desquamation or (other) clinically relevant non-hematological adverse event or non-hematologic adverse event at least possibly due to drug therapy. Or greater than or equal to grade 4: neutropenia or leukopenia or thrombocytopenia or radiation dermatitis or hematologic adverse event OR failure to administer greater than 75% of dasatinib TMZ or interruption of RT for more than 5 days due to adverse events.OR severe acute central nervous system deterioration attributable to TMZ, RT and or dasatinib which cannot be controlled with corticosteroid administration. The MTD for this study will be defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience DLT with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT. |
| Secondary | Progression-free Survival | Up to 5 years post treatment | Progression-free survival (PFS) is defined as the time from study registration to the date of first observation of disease progression or death due to any cause (whichever comes first). If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Only Phase II patients were evaluated for Progression-free survival |
| Secondary | Objective Response | Up to 5 years post treatment | Objective response to treatment will be determined by a combination of 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 proportion of patients in each response category will be summarized. Only phase II patients were evaluated for response. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Up to 5 years post treatment | Months | MEDIAN | |
| PRIMARY | The Number of Dose Limiting Toxicities(DLT) in Order to Determine Maximum Tolerable Dose(MTD) of Dasatinib Combined With Radiation and Temozolomide in This Patient Population. | Every cycle from first dose to end of rest period prior cycle 3 | Only Phase I patients were evaluated for maximum tolerable dose. | participants with Dose Limiting Toxicits | NUMBER |
| SECONDARY | Progression-free Survival | Up to 5 years post treatment | All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable | Months | MEDIAN |
| SECONDARY | Objective Response | Up to 5 years post treatment | Participants that have at least one disease evaluation for assessing best response to treatment. | Proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Group 1 (Phase II) Dasatinib + Radiation + Temozolomide | 15.6 | 95% Confidence Interval 14.4 to 19.6 | Months | |
| Overall Survival | Group 2 (Phase II) Placebo + Radiation + Temozolomide | 19.3 | 95% Confidence Interval 16.1 to 21.7 | Months | |
| The Number of Dose Limiting Toxicities(DLT) in Order to Determine Maximum Tolerable Dose(MTD) of Dasatinib Combined With Radiation and Temozolomide in This Patient Population. | Dose Level 0 Phase I | 1 | participants with Dose Limiting Toxicits | ||
| The Number of Dose Limiting Toxicities(DLT) in Order to Determine Maximum Tolerable Dose(MTD) of Dasatinib Combined With Radiation and Temozolomide in This Patient Population. | Dose Level 0-A Phase I | 0 | participants with Dose Limiting Toxicits | ||
| The Number of Dose Limiting Toxicities(DLT) in Order to Determine Maximum Tolerable Dose(MTD) of Dasatinib Combined With Radiation and Temozolomide in This Patient Population. | Dose Level 1 Phase I | 1 | participants with Dose Limiting Toxicits | ||
| Progression-free Survival | Group 1 (Phase II) Dasatinib + Radiation + Temozolomide | 6.2 | 95% Confidence Interval 4.4 to 8.2 | Months | |
| Progression-free Survival | Group 2 (Phase II) Placebo + Radiation + Temozolomide | 7.8 | 95% Confidence Interval 6.5 to 10.9 | Months | |
| Objective Response | Group 1 (Phase II) Dasatinib + Radiation + Temozolomide | Progression | .31 | Proportion of participants | |
| Objective Response | Group 2 (Phase II) Placebo + Radiation + Temozolomide | Progression | .19 | Proportion of participants | |
| Objective Response | Group 1 (Phase II) Dasatinib + Radiation + Temozolomide | Stable | .59 | Proportion of participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 0 Phase I | 3 | |
| Overall Study | STARTED | Dose Level 0-A Phase I | 3 | |
| Overall Study | STARTED | Dose Level 1 Phase I | 7 | |
| Overall Study | STARTED | Group 1 (Phase II) Dasatinib + Radiation + Temozolomide | 138 | |
| Overall Study | STARTED | Group 2 (Phase II) Placebo + Radiation + Temozolomide | 66 | |
| Overall Study | COMPLETED | Dose Level 0 Phase I | 3 | |
| Overall Study | COMPLETED | Dose Level 0-A Phase I | 3 | |
| Overall Study | COMPLETED | Dose Level 1 Phase I | 7 | |
| Overall Study | COMPLETED | Group 1 (Phase II) Dasatinib + Radiation + Temozolomide | 133 | |
| Overall Study | COMPLETED | Group 2 (Phase II) Placebo + Radiation + Temozolomide | 63 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events980
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 | Blood disorder | Blood and lymphatic system disorders | Dose Level 0 Phase I | 0 | 3 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Dose Level 0-A Phase I | 0 | 3 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Dose Level 1 Phase1 | 0 | 7 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Group 2 (Phase II) Placebo + Radiation + Temozolomide | 1 | 133 | 1 |
| other | Blood disorder | Blood and lymphatic system disorders | Group 1 (Phase II) Dasatinib + Radiation + Temozolomide | 0 | 63 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dose Level 0 Phase I | 0 | 3 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dose Level 0-A Phase I | 0 | 3 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dose Level 1 Phase1 | 0 | 7 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group 2 (Phase II) Placebo + Radiation + Temozolomide | 1 | 133 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Group 1 (Phase II) Dasatinib + Radiation + Temozolomide | 0 | 63 | 0 |
1 to 10 of 980Source ClinicalTrials.gov
See all 980 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 0 Phase I | ||
| Total, all-cause mortality | Dose Level 0-A Phase I | ||
| Total, all-cause mortality | Dose Level 1 Phase1 | ||
| Total, all-cause mortality | Group 2 (Phase II) Placebo + Radiation + Temozolomide | ||
| Total, all-cause mortality | Group 1 (Phase II) Dasatinib + Radiation + Temozolomide | ||
| Total, other adverse events | Dose Level 0 Phase I | 3 | 3 |
| Total, other adverse events | Dose Level 0-A Phase I | 3 | 3 |
| Total, other adverse events | Dose Level 1 Phase1 | 7 | 7 |
| Total, other adverse events | Group 2 (Phase II) Placebo + Radiation + Temozolomide | 133 | 133 |
| Total, other adverse events | Group 1 (Phase II) Dasatinib + Radiation + Temozolomide | 62 | 63 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40579995 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA025224 | North Central Cancer Treatment Group | BUCKNER, JAN C | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
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/NCT00869401
GET https://conductscience.org/api/trials/v1/NCT00869401/events?page=2