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Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma


Inclusion Criteria:



- Adult patients, >/=18 years of age

- Histologically confirmed glioblastoma

- Radiographic demonstration of disease progression by Response Assessment in
Neurooncology (RANO) criteria following prior therapy

- Availability of at least 1 formalin-fixed paraffin-embedded tumor tissue sample

- If receiving corticosteroids, patients must have been on a stable or decreasing dose
of corticosteroids

- Prior standard radiotherapy for glioblastoma

- Karnofsky Performance status >/=70

- Over 4 weeks since prior surgical resection

- Over 12 weeks from radiotherapy

- Over 4 weeks from anticancer agents

Exclusion Criteria:

- Patients had second or later glioblastoma relapse

- Patients received more than one systemic treatment regimen for glioblastoma

- Patients have secondary glioblastoma

- Prior treatment with Avastin

- Patients unable to undergo Magnetic Resonance Imaging (MRI)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose-Finding Part: Dose limiting toxicity

Outcome Time Frame:

Day 28

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: Ministry of Health

Study ID:

BP25389

NCT ID:

NCT01308684

Start Date:

May 2011

Completion Date:

April 2013

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma

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