Trial information
A Study of Tarceva (Erlotinib) in Patients With Recurrent Glioblastoma Multiforme
Status: No longer recruiting
Protocol number: BO17884
Sponsor: F Hoffmann -La Roche Ltd/ Inc/AG
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of Tarceva and either temozolomide or BCNU on progression-free survival in patients with recurrent glioblastoma multiforme
Brief summary: This study will assess the efficacy and safety of Tarceva compared to that of one of 2 comparator drugs (depending on pre-treatment of patients) in patients with recurrent glioblastoma multiforme. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Target sample size is
110.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Glioblastoma multiforme
Intervention type: Drug
Intervention name: erlotinib[Tarceva]
Primary outcome: 1. Progression-free survival probability at 6 months
Key secondary outcomes: 1. Response rate and duration of response; acute side effects; and overall survival
Inclusion criteria:
- adult patients >18 years of age;
- glioblastoma multiforme;
- recurrent disease documented by MRI after previous radiation therapy;
- stable or decreasing dose of corticosteroids for >=2 weeks before treatment initiation;
- Karnofsky performance status >=70.
Exclusion criteria:
- previous treatment for recurrent disease;
- >1 previous chemotherapy regimen given as adjuvant treatment;
- previous treatment with her-targeted agents or experimental therapies;
- previous irradiation to the brain within 3 months of randomization;
- concomitant treatment with anticoagulants.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2004
Trial registration date: 06/24/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
France
- Nice
- Paris
- Saint Herblain
- Villejuif
Italy
Netherlands
United Kingdom
