Glioblastoma
Conditions
Brief summary
To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma
Interventions
DRUGDasatinib
Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity
DRUGLomustine
Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histological or cytological proven glioblastoma multiforme * Recurrent or progressive disease documented by magnetic resonance imaging (MRI) * World Health Organization (WHO) Performance status 0 - 2 * Patient may have been operated for recurrence * For non operated patients, recurrent disease must be at least one bidimensionally measurable target lesion with one diameter of at least 2cm * Patients must be on a stable or decreasing dose of corticosteroids for at least 1 week prior to baseline MRI
Exclusion criteria
* Patients with histological or cytological proven glioblastoma multiforme * Completion of radiotherapy to the brain less than 3 months prior to registration/randomization * Prior treatment with high dose radiotherapy, stereotactic radiosurgery or internal radiation therapy * Previous or current malignancy at other sites within prior 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). | — |
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Disease Progression at 12 Months | 12 months | As measured by brain magnetic resonance imaging. |
Countries
France, Italy, Netherlands, Switzerland
Participant flow
Pre-assignment details
Of 28 participants enrolled in this study, 26 received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Dose Level 1A Dasatinib: 100 mg once daily (QD) cycle 1 / 100 mg twice daily (BID) cycle 2 + lomustine (CCNU): 110 mg/m² | 6 |
| Dose Level 1B Dasatinib: 100 mg QD / 100mg BID + CCNU: 90 mg/m² | 3 |
| Dose Level 2 Dasatinib: 100 mg BID + CCNU: 90 mg/m² | 7 |
| Dose Level 3A Dasatinib: 150 mg/day (100 mg AM and 50 mg PM) + CCNU: 90 mg/m² | 9 |
| Dose Level 3B Dasatinib: 100 mg/day (QD) + CCNU: 90 mg/m² | 1 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Both Progression and Toxicity | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Disease Progression/Relapse/Death | 3 | 3 | 7 | 8 | 1 |
| Overall Study | Thrombocytopenia, Grade 4 | 2 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Dose Level 3B | Dose Level 3A | Dose Level 2 | Dose Level 1B | Dose Level 1A |
|---|---|---|---|---|---|---|
| Age Continuous | 54.8 years | 51.1 years | 49.7 years | 53.6 years | 57.7 years | 58.8 years |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0 | 14 participants | 1 participants | 4 participants | 1 participants | 2 participants | 6 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1 | 10 participants | 0 participants | 4 participants | 5 participants | 1 participants | 0 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2 | 2 participants | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants |
| Histological Diagnosis of Primary Disease glioblastoma multiforme | 22 participants | 1 participants | 8 participants | 5 participants | 2 participants | 6 participants |
| Histological Diagnosis of Primary Disease glioblastoma w/ oligodendroglial component | 4 participants | 0 participants | 1 participants | 2 participants | 1 participants | 0 participants |
| Sex: Female, Male Female | 6 Participants | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 20 Participants | 1 Participants | 6 Participants | 5 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 6 | 3 / 3 | 7 / 7 | 9 / 9 | 1 / 1 |
| serious Total, serious adverse events | 5 / 6 | 1 / 3 | 4 / 7 | 3 / 9 | 0 / 1 |
Outcome results
Primary
Deaths Within 30 Days of Protocol Treatment Discontinuation
Time frame: 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).
Population: Treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Deaths Within 30 Days of Protocol Treatment Discontinuation | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Deaths Within 30 Days of Protocol Treatment Discontinuation | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Deaths Within 30 Days of Protocol Treatment Discontinuation | 1 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Deaths Within 30 Days of Protocol Treatment Discontinuation | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Deaths Within 30 Days of Protocol Treatment Discontinuation | 0 participants |
Primary
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
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.
Time frame: 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).
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R Gr 3/4 AE | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Discontinuations Due to AEs | 3 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Tx-R Deaths within 30 days of Tx Discontinuation | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 AE | 6 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R AE | 5 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 SAE | 5 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Gr 3/4 AE | 2 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R SAE | 4 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Deaths within 30 days of Tx Discontinuation | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Gr 3/4 AE | 2 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 AE | 3 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R SAE | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Discontinuations Due to AEs | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 SAE | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R Gr 3/4 AE | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Tx-R Deaths within 30 days of Tx Discontinuation | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Deaths within 30 days of Tx Discontinuation | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R AE | 2 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 AE | 7 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Deaths within 30 days of Tx Discontinuation | 1 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Tx-R Deaths within 30 days of Tx Discontinuation | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 SAE | 4 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R SAE | 1 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Discontinuations Due to AEs | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Gr 3/4 AE | 4 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R AE | 5 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R Gr 3/4 AE | 0 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R SAE | 1 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 AE | 9 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 SAE | 4 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Gr 3/4 AE | 4 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Tx-R Deaths within 30 days of Tx Discontinuation | 0 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R Gr 3/4 AE | 0 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R AE | 7 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Deaths within 30 days of Tx Discontinuation | 0 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Discontinuations Due to AEs | 1 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Deaths within 30 days of Tx Discontinuation | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R SAE | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 AE | 1 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 SAE | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Discontinuations Due to AEs | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R Gr 3/4 AE | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Tx-R AE | 1 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | At Least 1 Gr 3/4 AE | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | Tx-R Deaths within 30 days of Tx Discontinuation | 0 participants |
Primary
Number of Participants With Dose-limiting Toxicities (DLTs)
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.
Time frame: 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.
Population: Evaluable Participants: subset of participants used to decide on dose escalations. Participants were assessable if they completed the period for DLT observation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Dose-limiting Toxicities (DLTs) | 3 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Dose-limiting Toxicities (DLTs) | 3 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Dose-limiting Toxicities (DLTs) | 4 participants |
Primary
Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria
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.
Time frame: 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).
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hyponatremia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hyperkalemia | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypophosphatemia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypernatremia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Creatinine | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 3-4 Hypokalemia | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Aspartate Aminotransferase / AST | 2 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr1-4 Hyperbilirubinemia | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypokalemia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypocalcemia | 3 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hyperkalemia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr1-4 Hyperbilirubinemia | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Aspartate Aminotransferase / AST | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 3-4 Hypokalemia | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hyponatremia | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypokalemia | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypernatremia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Creatinine | 2 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypocalcemia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypophosphatemia | 1 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypokalemia | 1 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Aspartate Aminotransferase / AST | 4 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypocalcemia | 3 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Creatinine | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hyperkalemia | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypophosphatemia | 1 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hyponatremia | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr1-4 Hyperbilirubinemia | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypernatremia | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 3-4 Hypokalemia | 0 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypophosphatemia | 3 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypokalemia | 3 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hyperkalemia | 0 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hyponatremia | 0 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypernatremia | 5 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Creatinine | 0 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypocalcemia | 2 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr1-4 Hyperbilirubinemia | 0 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Aspartate Aminotransferase / AST | 6 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 3-4 Hypokalemia | 1 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Aspartate Aminotransferase / AST | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypocalcemia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Creatinine | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypernatremia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypophosphatemia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hyponatremia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hyperkalemia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 1-4 Hypokalemia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr1-4 Hyperbilirubinemia | 1 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | At least 1 Gr 3-4 Hypokalemia | 0 participants |
Primary
Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria
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).
Time frame: 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).
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Lymphocytopenia | 5 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Anemia | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Thrombocytopenia | 6 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Thrombocytopenia | 4 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Lymphocytopenia | 4 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Leukopenia | 5 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Neutropenia | 3 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Leukopenia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Neutropenia | 2 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Anemia | 6 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Leukopenia | 3 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Neutropenia | 2 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Lymphocytopenia | 2 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Thrombocytopenia | 3 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Anemia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Neutropenia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Leukopenia | 1 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Lymphocytopenia | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Thrombocytopenia | 0 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Anemia | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Neutropenia | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Thrombocytopenia | 2 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Lymphocytopenia | 4 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Thrombocytopenia | 6 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Leukopenia | 4 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Anemia | 6 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Leukopenia | 0 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Neutropenia | 2 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Anemia | 1 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Lymphocytopenia | 1 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Leukopenia | 6 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Anemia | 0 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Neutropenia | 5 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Lymphocytopenia | 9 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Neutropenia | 4 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Lymphocytopenia | 5 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Thrombocytopenia | 5 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Leukopenia | 4 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Thrombocytopenia | 9 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Anemia | 9 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Thrombocytopenia | 1 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Thrombocytopenia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Anemia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Neutropenia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Anemia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Leukopenia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Neutropenia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 3-4 Lymphocytopenia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Lymphocytopenia | 0 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | At least 1 Grade 1-4 Leukopenia | 0 participants |
Other Pre-specified
Number of Participants With Disease Progression at 12 Months
As measured by brain magnetic resonance imaging.
Time frame: 12 months
Population: Treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Number of Participants With Disease Progression at 12 Months | 6 participants |
| Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Disease Progression at 12 Months | 3 participants |
| Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Number of Participants With Disease Progression at 12 Months | 7 participants |
| Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Number of Participants With Disease Progression at 12 Months | 9 participants |
| Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Number of Participants With Disease Progression at 12 Months | 1 participants |