Trial · NCT00948389
Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)
NCT00948389, Phase 1, Phase 2, Terminated, Bristol-Myers Squibb; results first posted 2012-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM). Trials, record NCT00948389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00948389
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)
- NCT number
- NCT00948389
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Glioblastoma
- Interventions
- Dasatinib, Lomustine
- First posted
- 2009-07-29
- Last updated
- 2012-08-31
- Other registries' IDs
- eudract:2009-010576-21
- Results first posted
- 2012-08-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0). | SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongation. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related(Tx-R)=certainly, probably, possibly related and unknown relationship to study drug. AE grades(Gr) 1=Mild; 2=Moderate; 3=Severe; 4=Life-threatening. |
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | The duration for observation of DLT was 2 6-week cycles in participants with escalated dose (QD to BID) and 1 6 -week cycle for participants starting with BID regime. For participants receiving dasatinib at 150 mg, DLTs were only documented over cycle 1. | Grades (gr) according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLTs were defined as adverse drug reactions as follows: absolute neutrophil counts \<0.5x10\^9/L (gr4) lasting for 7 consecutive days; febrile neutropenia (neutrophil count \<1x10\^9/L and fever of \>=38.5°C); thrombocytopenia (gr4); any gr3/4 nonhematological toxicity except nausea, vomiting and fever which could be rapidly controlled with appropriate measures; any toxicity which did not allow administering at least 70% of the intended dose intensity for both agents. |
| Primary | Deaths Within 30 Days of Protocol Treatment Discontinuation | From time of randomization through within 30 days after protocol treatment discontinuation. Median (full range) number of 6-week treatment cycles was 1.0 (1.0-7.0). | |
| Primary | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0). | Neutrophils (neutropenia): Grade (gr)1 \<LLN-1500/mm3; Gr2 \<1500-1000/mm3; Gr3 \<1000-500/mm3; Gr4 \<500/mm3. Leukocytes (leukopenia): Gr1 \<LLN-3000/mm3; Gr2 \<3000-2000/mm3; Gr3 \<2000-1000/mm3; Gr4 \<1000/mm3. Lymphocytes (lymphocytopenia): Gr1 \<LLN-800/mm3; Gr2 \<800-500/mm3; Gr3 \<500-200/mm3; Gr4 \<200/mm3. Platelets (thrombocytopenia): Gr1 \<LLN-75,000/mm3; Gr2 \<75,000-50,000/mm3; Gr3 \<50,000-25,000/mm3; Gr4 \<25,000/mm3. Hemoglobin (anemia): Gr1 \<LLN-10.0 g/dL; Gr2 \<10.0-8.0 g/dL; Gr3 \<8.0-6.5 g/dL; Gr4 \<6.5 g/dL. LLN/ULN=lower/upper limit of normal (normal ranges may vary by local laboratories). |
| Primary | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after 6 cycles. Median number of cycles = 1.0 (range: 1.0 - 7.0). | Grades (gr) 1=mild; gr2=moderate; gr3=severe; gr4=life-threatening. For details of NCI CTCAE laboratory values for each grade, please refer to http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm#ctc\_30. Low Potassium=Hypokalemia, High Potassium=Hyperkalemia, Low Sodium=Hyponatremia, Low Calcium=Hypocalcemia, High Bilirubin=Hyperbilirubinemia, low phosphatase=Hypophosphatemia, Low Potassium=Hypokalemia. |
| Other | Number of Participants With Disease Progression at 12 Months | 12 months | As measured by brain magnetic resonance imaging. |
Source ClinicalTrials.gov
Outcomes6
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 Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0). | All treated participants | participants | NUMBER |
| PRIMARY | Number of Participants With Dose-limiting Toxicities (DLTs) | The duration for observation of DLT was 2 6-week cycles in participants with escalated dose (QD to BID) and 1 6 -week cycle for participants starting with BID regime. For participants receiving dasatinib at 150 mg, DLTs were only documented over cycle 1. | Evaluable Participants: subset of participants used to decide on dose escalations. Participants were assessable if they completed the period for DLT observation. | participants | NUMBER |
| PRIMARY | Deaths Within 30 Days of Protocol Treatment Discontinuation | From time of randomization through within 30 days after protocol treatment discontinuation. Median (full range) number of 6-week treatment cycles was 1.0 (1.0-7.0). | Treated participants | participants | NUMBER |
| PRIMARY | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0). | Treated participants | participants | NUMBER |
| PRIMARY | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after 6 cycles. Median number of cycles = 1.0 (range: 1.0 - 7.0). | Treated participants | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Disease Progression at 12 Months | 12 months | Treated participants | participants | NUMBER |
Source ClinicalTrials.gov
Results by group158
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 Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Deaths within 30 days of Tx Discontinuation | 1 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Deaths within 30 days of Tx Discontinuation | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Deaths within 30 days of Tx Discontinuation | 1 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Deaths within 30 days of Tx Discontinuation | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Deaths within 30 days of Tx Discontinuation | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Tx-R Deaths within 30 days of Tx Discontinuation | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Tx-R Deaths within 30 days of Tx Discontinuation | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Tx-R Deaths within 30 days of Tx Discontinuation | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Tx-R Deaths within 30 days of Tx Discontinuation | 0 | participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Tx-R Deaths within 30 days of Tx Discontinuation | 0 | participants |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | 6 | |
| Overall Study | STARTED | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | 3 | |
| Overall Study | STARTED | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | 7 | |
| Overall Study | STARTED | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | 9 | |
| Overall Study | STARTED | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | 1 | |
| Overall Study | COMPLETED | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events430
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 | Agitation | Psychiatric disorders | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | 1 | 6 | |
| other | Agitation | Psychiatric disorders | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | 1 | 3 | |
| other | Agitation | Psychiatric disorders | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | 0 | 7 | |
| other | Agitation | Psychiatric disorders | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | 0 | 9 | |
| other | Agitation | Psychiatric disorders | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | 0 | 1 | |
| other | Anxiety | Psychiatric disorders | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | 0 | 6 | |
| other | Anxiety | Psychiatric disorders | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | 0 | 3 | |
| other | Anxiety | Psychiatric disorders | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | 0 | 7 | |
| other | Anxiety | Psychiatric disorders | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | 1 | 9 | |
| other | Anxiety | Psychiatric disorders | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | 0 | 1 |
1 to 10 of 430Source ClinicalTrials.gov
See all 430 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | ||
| Total, all-cause mortality | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | ||
| Total, all-cause mortality | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | ||
| Total, all-cause mortality | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | ||
| Total, all-cause mortality | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | ||
| Total, other adverse events | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | 6 | 6 |
| Total, other adverse events | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | 3 | 3 |
| Total, other adverse events | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | 7 | 7 |
| Total, other adverse events | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | 9 | 9 |
| Total, other adverse events | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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.
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/NCT00948389
GET https://conductscience.org/api/trials/v1/NCT00948389/results?page=2