EUCTR2011-004418-40-DEActive, not recruitingPhase 1
A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 180
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Male and female patients at or older than 18 years and who have relapsed Glioblastoma after first-line treatment with chemoradiation, have measureable disease (response to be based on RANO criteria), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
Exclusion Criteria
- •Moderate or severe cardiac condition. Prior treatment with nitrosurea. Prior treatment with bevacizumab as part of a first-line treatment for GB, Serious concomitant systemic disorder, Current acute or chronic myelogenous leukemia, Second primary malignancy, Pregnant or breast-feeding women
Investigators
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