Trial · NCT00423735
Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma
NCT00423735, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-01-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma. Trials, record NCT00423735. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00423735
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma
- NCT number
- NCT00423735
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm
- Interventions
- Dasatinib, Pharmacological Study
- First posted
- 2007-01-18
- Last updated
- 2019-07-24
- Results first posted
- 2015-01-06
- Limitations and caveats
- Designed as a 2-stage study. The protocol was amended after Stage 1 to add Stage 1B allowing intra-patient escalation. Per protocol criteria, the study did not continue to Stage 2.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Achieving 6-month Progression-free Survival (6mPFS) | Registration to 6 months | This study utilized a two-stage phase II design (Stage 1B and 2). The primary endpoint of 6-month progression-free survival (6mPFS) would be assessed based on the patients combined from 1B and 2 if the study continued to Stage 2. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. If the first stage met its criteria (see secondary outcome measure), then accrual would continue, otherwise there would be no further accrual and the alternative hypothesis would be rejected. Following Stage 2 accrual completion and 6 months of follow-up, if 9 or more patients were alive without progression by 6 months, the null hypothesis would be rejected in favor of the alternative. |
| Secondary | Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS) | Registration to 6 months | Study design and efficacy determination uses the hybrid endpoint of 6mPFS or complete/partial response of any duration prior to or at 6 months. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. Stage 1 and 1B: If 2 or fewer patients were alive and progression-free at 6 months or achieved complete/partial response, then there would be no further accrual and the alternative hypothesis would be rejected. Otherwise accrual would continue to a total of 50 analyzable patients to address the primary endpoint. Complete Response: Complete disappearance of all enhancing tumor on consecutive CT or MRI scans at least 1 month apart; off corticosteroids; neurologically stable/improved. Partial Response: ≥ 50% decrease in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart; corticosteroids stable/reduced; neurologically stable/improved. |
| Secondary | Overall Survival | Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) | Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. The study is not designed for a comparison of the treatment arms to each other. |
| Secondary | Treatment Response Rates at Six Months | From registration to 6 months | Best response is assessed using standard criteria for patients with malignant gliomas (Macdonald 1990) as reported by the site. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive CT or MRI scans at least 1 month apart; off corticosteroids; neurologically stable/improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart; corticosteroids stable/reduced; neurologically stable/improved. Stable disease (SD): Does not qualify for CR, PR, or PD. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor; neurologically worse; steroids stable/increased. The best tumor response is defined as the best radiographic response for patients evaluable for radiographic response prior to progression, up to six months. The study is not designed for a comparison of the treatment arms to each other. |
| Secondary | Progression-free Survival | Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) | Progression-free survival time is measured from randomization to the date of first progression or death, else the last follow-up date on which the patient was reported alive, and is estimated by the Kaplan-Meier method. Progression is defined as ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased. The study is not designed for a comparison of the treatment arms to each other. |
| Secondary | Rate of Adverse Events | Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) | The rate of patients' worst overall grade of adverse event is reported. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The study is not designed for a comparison of the treatment arms to each other. |
| Secondary | Correlation of Molecular Markers and Tumor Response | From registration to 6 months | The following markers were examined: p-SRC, PDGFR, EPHA2, c-KIT. Patients were categorized based on the number of positive molecular markers they had: 2 vs. 3 and 4. Correlation of marker category and best tumor response was tested using Fisher's exact test. The best tumor response is defined as the best radiographic response for patients evaluable for radiographic response prior to progression up to six months. Patients are combined from the two treatment arms. |
| Secondary | Correlation of Pharmacokinetic Data With Dosing, Toxicity, and Efficacy | Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) | Sufficient pharmacokinetic data was not obtained. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Achieving 6-month Progression-free Survival (6mPFS) | Registration to 6 months | Eligible patients who started protocol treatment. | participants | NUMBER |
| SECONDARY | Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS) | Registration to 6 months | Eligible patients who started protocol treatment. | participants | NUMBER |
| SECONDARY | Overall Survival | Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) | Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months. Arms are not compared. | months | MEDIAN |
| SECONDARY | Treatment Response Rates at Six Months | From registration to 6 months | Eligible patients who started study treatment | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) | Eligible patients who started study treatment | months | MEAN |
| SECONDARY | Rate of Adverse Events | Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) | Eligible patients who started protocol treatment | percentage of participants | NUMBER |
| SECONDARY | Correlation of Molecular Markers and Tumor Response | From registration to 6 months | Eligible patients who started study treatment and whose response was assessed | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Correlation of Pharmacokinetic Data With Dosing, Toxicity, and Efficacy | Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.) |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Achieving 6-month Progression-free Survival (6mPFS) | Stage 1: Dasatinib 200mg/Day | 1 | participants | ||
| Number of Patients Achieving 6-month Progression-free Survival (6mPFS) | Stage 1B: Dasatinib up to 400mg/Day | 2 | participants | ||
| Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS) | Stage 1: Dasatinib 200mg/Day | 1 | participants | ||
| Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS) | Stage 1B: Dasatinib up to 400mg/Day | 2 | participants | ||
| Overall Survival | Stage 1: Dasatinib 200mg/Day | 6.5 | 95% Confidence Interval 3.5 to 9.5 | months | |
| Overall Survival | Stage 1B: Dasatinib up to 400mg/Day | 8.9 | 95% Confidence Interval 5.0 to 11.3 | months | |
| Treatment Response Rates at Six Months | Stage 1: Dasatinib 200mg/Day | CR or PR | 0.0 | percentage of participants | |
| Treatment Response Rates at Six Months | Stage 1B: Dasatinib up to 400mg/Day | CR or PR | 0.0 | percentage of participants | |
| Treatment Response Rates at Six Months | Stage 1: Dasatinib 200mg/Day | Stable | 19.0 | percentage of participants | |
| Treatment Response Rates at Six Months | Stage 1B: Dasatinib up to 400mg/Day | Stable | 27.6 | percentage of participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stage 1: Dasatinib 200mg/Day | 29 | |
| Overall Study | STARTED | Stage 1B: Dasatinib up to 400mg/Day | 35 | |
| Overall Study | STARTED | Stage 2: Dasatinib up to 400mg/Day | 0 | |
| Overall Study | COMPLETED | Stage 1: Dasatinib 200mg/Day | 21 | |
| Overall Study | COMPLETED | Stage 1B: Dasatinib up to 400mg/Day | 29 | |
| Overall Study | COMPLETED | Stage 2: Dasatinib up to 400mg/Day | 0 | |
| Overall Study | NOT COMPLETED | Stage 1: Dasatinib 200mg/Day | 8 | |
| Overall Study | NOT COMPLETED | Stage 1B: Dasatinib up to 400mg/Day | 6 | |
| Overall Study | NOT COMPLETED | Stage 2: Dasatinib up to 400mg/Day | 0 |
Source ClinicalTrials.gov
Adverse events368
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/bone marrow - Other: | Blood and lymphatic system disorders | Stage 1: Dasatinib 200mg/Day | 2 | 21 | |
| other | Blood/bone marrow - Other: | Blood and lymphatic system disorders | Stage 1B: Dasatinib up to 400mg/Day | 0 | 29 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Stage 1: Dasatinib 200mg/Day | 13 | 21 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Stage 1B: Dasatinib up to 400mg/Day | 12 | 29 | |
| other | Cardiac General - Other: | Cardiac disorders | Stage 1: Dasatinib 200mg/Day | 2 | 21 | |
| other | Cardiac General - Other: | Cardiac disorders | Stage 1B: Dasatinib up to 400mg/Day | 0 | 29 | |
| other | Myocardial ischaemia | Cardiac disorders | Stage 1: Dasatinib 200mg/Day | 1 | 21 | |
| other | Myocardial ischaemia | Cardiac disorders | Stage 1B: Dasatinib up to 400mg/Day | 0 | 29 | |
| other | Sinus tachycardia | Cardiac disorders | Stage 1: Dasatinib 200mg/Day | 3 | 21 | |
| other | Sinus tachycardia | Cardiac disorders | Stage 1B: Dasatinib up to 400mg/Day | 0 | 29 |
1 to 10 of 368Source ClinicalTrials.gov
See all 368 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1: Dasatinib 200mg/Day | ||
| Total, all-cause mortality | Stage 1B: Dasatinib up to 400mg/Day | ||
| Total, other adverse events | Stage 1: Dasatinib 200mg/Day | 21 | 21 |
| Total, other adverse events | Stage 1B: Dasatinib up to 400mg/Day | 23 | 29 |
| Total, serious adverse events | Stage 1: Dasatinib 200mg/Day | 8 | 21 |
| Total, serious adverse events | Stage 1B: Dasatinib up to 400mg/Day | 14 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25758746 | DERIVED |
Source PubMed
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021661 | Radiation Therapy Oncology Group | CURRAN, WALTER J. | AMERICAN COLLEGE OF RADIOLOGY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Stage 1: Dasatinib 200mg/Day vs Stage 1B: Dasatinib up to 400mg/Day: Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS) | Trial comparisons |
| Stage 1: Dasatinib 200mg/Day vs Stage 1B: Dasatinib up to 400mg/Day: serious adverse events | 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/NCT00423735
GET https://conductscience.org/api/trials/v1/NCT00423735/results?page=2