At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 240 enrolled
Drug / intervention
Imatinib mesylate +1 moredrug
Likely dose
Imatinib mesylate 100 mgfrom record
Key inclusion· 8
- ✓Histologically confirmed diagnosis of glioblastoma multiforme or astrocytoma WHO grade IV
- ✓Age ≥18 years
- ✓ECOG performance status 0, 1, or 2
- ✓Prior radiation therapy 54–62 Gy completed according to national standards
Key exclusion· 8
- ✕Pregnant or breastfeeding
- ✕Prior investigational agent within 28 days of first study drug dose
- ✕Uncontrolled medical diseases (diabetes, thyroid dysfunction, neuropsychiatric disorders, infection, angina, Grade 3–4 cardiac disease)
- ✕Other active malignancies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma
In Brief
A Phase 3 clinical trial evaluating Imatinib mesylate and Hydroxyurea for Glioblastoma Multiforme and Astrocytoma. Completed, enrolled 240 participants across 1 site.
Detailed Summary
This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy with hydroxyurea monotherapy in patients with temozolomide resistant progressive glioblastoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma Multiforme, Astrocytoma
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2004
First PostedSep 2005
Primary CompletionAug 2008
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartOct 1, 2004
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.8 years ago
Interventions
Imatinib mesylatedrug
Imatinib was supplied as 100 mg and 400 mg tablets packaged in polyethylene bottles.
Hydroxyureadrug