Trial Information

Summary: 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 Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

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

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2004

Trial Registration Date: 06/24/2005

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Padova, Italy, 35128
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 7, 2008 at 3:12:53 PM


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