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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01308684
First received: March 2, 2011
Last updated: August 4, 2014
Last verified: August 2014

March 2, 2011
August 4, 2014
May 2011
February 2013   (final data collection date for primary outcome measure)
  • Dose-Finding Part: Dose limiting toxicity [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Efficacy-Finding part: Progression-free survival [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01308684 on ClinicalTrials.gov Archive Site
  • Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
  • Dose-Finding part: Safety (incidence of adverse events) [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Dose-Finding part: Glioblastoma biomarker [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
  • Efficacy-Finding part: Overall Response Rate [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
  • Efficacy-Finding part: Disease Control Rate [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
  • Efficacy-Finding part: Duration of Response [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
  • Efficacy-Finding part: Progression-free survival [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
  • Efficacy-Finding part: Overall Survival [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
  • Efficacy-Finding part: Safety (incidence of adverse events) [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
  • Efficacy-Finding part: Glioblastoma biomarker [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
  • Efficacy-Finding part: Pharmacokinetics (serum levels) of RO5323441 and Avastin when combined [ Time Frame: From baseline to disease progression or death (>12 months) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent Glioblastoma
Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma

This open-label, multicenter study will evaluate the safety and efficacy of RO53 23441 in combination with Avastin (bevacizumab) in patients with recurrent gliob lastoma. 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 establish ed 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 Ava stin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatme nt until disease progression or death.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
  • 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
  • Drug: bevacizumab [Avastin]
    Efficacy-Finding part: 10 mg/kg intravenously once every two weeks
  • Experimental: 1
    Intervention: Drug: RO5323441 + bevacizumab [Avastin]
  • Experimental: 2
    Intervention: Drug: bevacizumab [Avastin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
February 2013
February 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Switzerland,   United Kingdom
 
NCT01308684
BP25389, 2010-021795-29
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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