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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Glioblastoma

Treatments: Drug: Lomustine; Drug: Dasatinib

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00948389

CA180-274

2009-010576-21 (EudraCT Number)

Protocol 26083 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Dasatinib

Active Comparator group

Treatment:

Drug: Dasatinib

Lomustine

Active Comparator group

Treatment:

Drug: Lomustine