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A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent Glioblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308684
First Posted: March 4, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue treatment with RO5323441 and Avastin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatment until disease progression or death.

Condition Intervention Phase
Glioblastoma Multiforme Drug: RO5323441 + bevacizumab [Avastin] Drug: bevacizumab [Avastin] Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Dose-Finding Part: Dose limiting toxicity [ Time Frame: Day 28 ]
  • Efficacy-Finding part: Progression-free survival [ Time Frame: From baseline to disease progression or death (>12 months) ]

Secondary Outcome Measures:
  • Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Dose-Finding part: Safety (incidence of adverse events) [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Dose-Finding part: Efficacy (tumor response according to Response Assessment in Neurooncology (RANO) criteria [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Dose-Finding part: Glioblastoma biomarker [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Efficacy-Finding part: Overall Response Rate [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Efficacy-Finding part: Disease Control Rate [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Efficacy-Finding part: Duration of Response [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Efficacy-Finding part: Progression-free survival [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Efficacy-Finding part: Overall Survival [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Efficacy-Finding part: Safety (incidence of adverse events) [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Efficacy-Finding part: Glioblastoma biomarker [ Time Frame: From baseline to disease progression or death (>12 months) ]
  • Efficacy-Finding part: Pharmacokinetics (serum levels) of RO5323441 and Avastin when combined [ Time Frame: From baseline to disease progression or death (>12 months) ]

Enrollment: 22
Study Start Date: May 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO5323441 + bevacizumab [Avastin]
Dose-Finding part: RO5323441 intravenous escalating doses once every two weeks; Efficacy-Finding part: established dose from the Dose-Finding part; Avastin: 10 mg/kg intravenously once every two weeks
Experimental: 2 Drug: bevacizumab [Avastin]
Efficacy-Finding part: 10 mg/kg intravenously once every two weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308684


Locations
Denmark
København Ø, Denmark, 2100
France
Marseille, France, 13385
Switzerland
Zürich, Switzerland, 8091
United Kingdom
Manchester, United Kingdom, M2O 4BX
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01308684     History of Changes
Other Study ID Numbers: BP25389
2010-021795-29
First Submitted: March 2, 2011
First Posted: March 4, 2011
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors