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A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 8, 2011
Last updated: November 3, 2014
Last verified: November 2014

November 8, 2011
November 3, 2014
November 2011
December 2013   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01474239 on Archive Site
  • Progression-free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Median Progression-free Survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Median Overall Survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Safety (Incidence of Adverse Events) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma
Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma

This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustin e 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment ar ms. The anticipated time of study treatment is until disease progression or unac ceptable toxicity.

Not Provided
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
  • Drug: bevacizumab [Avastin]
    10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity
  • Drug: fotemustine
    75 mg/m2 intravenously on days 1, 8 and 15 followed by, after a 5 weeks interval, 100 mg/m2 on day 1 of a 3-weeks cycle. Until disease progression or unacceptable toxicity
  • Experimental: Calibration Arm
    Intervention: Drug: fotemustine
  • Experimental: Investigational Arm
    Intervention: Drug: bevacizumab [Avastin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of recurrent glioblastoma multiforme (Grade IV)
  • Previous treatment with temozolomide and radiotherapy
  • First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy)
  • Adequate hematological, biochemical and organ functions

Exclusion Criteria:

  • Previous treatment with Avastin or other anti-angiogenic drugs
  • Residual relevant toxicity resulting from previous therapy
  • Radiotherapy within the 3 months prior to the diagnosis of disease progression
  • Chemotherapy in the previous 4 weeks
  • Other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma)
  • Clinically significant cardiovascular diseases
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP