Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma
NCT00418327 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2009-08-07
Summary
The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD) of Tarceva in children as single agent and in combination with radiation therapy
Conditions
- Malignant Brain Tumor
- Brain Stem Glioma,
Interventions
- DRUG
-
Tarceva (Erlotinib Hydrochloride)
tablets of 25 mg, 100 mg and 150 mg 75 to 150 mg/m² Once daily
Sponsors & Collaborators
-
Gustave Roussy, Cancer Campus, Grand Paris
lead OTHER
Principal Investigators
-
Vassal Gilles, Pr. · Gustave Roussy, Cancer Campus, Grand Paris
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-06-30
Countries
- France
Study Locations
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