Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Lomustine

Dasatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tyrosine

Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity

Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity

Bristol-Myers Squibb

To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma

Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)

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

As measured by brain magnetic resonance imaging.

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.

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.

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).

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.

European Organisation for Research and Treatment of Cancer - EORTC

Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m\^2.

Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2

Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m\^2

Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2

Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m\^2

Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2

Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m\^2

Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2

Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m\^2

Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2

Dasatinib: 100 mg once daily (QD) cycle 1 / 100 mg twice daily (BID) cycle 2 + lomustine (CCNU): 110 mg/m²

Dose Level 1A

Dasatinib: 100 mg QD / 100mg BID + CCNU: 90 mg/m²

Dose Level 1B

Dose Level 2

Dasatinib: 150 mg/day (100 mg AM and 50 mg PM) + CCNU: 90 mg/m²

Dose Level 3A

Dasatinib: 100 mg/day (QD) + CCNU: 90 mg/m²

Dose Level 3B

Total

Age Continuous

Sex: Female, Male

glioblastoma multiforme

glioblastoma w/ oligodendroglial component

Histological Diagnosis of Primary Disease

Grade 0

Grade 1

Grade 2

ECOG criteria is used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 0=normal activity; Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair.

Eastern Cooperative Oncology Group (ECOG) Performance Status

BMS Study Director

Deaths within 30 days of Tx Discontinuation

Tx-R Deaths within 30 days of Tx Discontinuation

At Least 1 SAE

At Least 1 Tx-R SAE

Discontinuations Due to AEs

At Least 1 AE

At Least 1 Gr 3/4 AE

At Least 1 Tx-R AE

At Least 1 Tx-R Gr 3/4 AE

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

Evaluable Participants: subset of participants used to decide on dose escalations. Participants were assessable if they completed the period for DLT observation.

Number of Participants With Dose-limiting Toxicities (DLTs)

Dose level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m\^2

Deaths Within 30 Days of Protocol Treatment Discontinuation

At least 1 Grade 1-4 Neutropenia

At least 1 Grade 1-4 Leukopenia

At least 1 Grade 1-4 Lymphocytopenia

At least 1 Grade 1-4 Thrombocytopenia

At least 1 Grade 1-4 Anemia

At least 1 Grade 3-4 Neutropenia

At least 1 Grade 3-4 Leukopenia

At least 1 Grade 3-4 Lymphocytopenia

At least 1 Grade 3-4 Thrombocytopenia

At least 1 Grade 3-4 Anemia

Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria

At least 1 Gr 1-4 Hypokalemia

At least 1 Gr 1-4 Hyperkalemia

At least 1 Gr 1-4 Hyponatremia

At least 1 Gr 1-4 Hypernatremia

At least 1 Gr 1-4 Creatinine

At least 1 Gr 1-4 Hypocalcemia

At least 1 Gr1-4 Hyperbilirubinemia

At least 1 Gr 1-4 Aspartate Aminotransferase / AST

At least 1 Gr 1-4 Hypophosphatemia

At least 1 Gr 3-4 Hypokalemia

Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria

Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m\^2

Number of Participants With Disease Progression at 12 Months

Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m\^2.

Overall Study

Spots Global Cancer Trial Database for Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial