Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.