Know Cancer

or
forgot password

Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

Thank you

Trial Information

Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministry of Health

Study ID:

ML25739

NCT ID:

NCT01474239

Start Date:

November 2011

Completion Date:

November 2014

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma

Name

Location