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

Primary Purpose

Glioblastoma Multiforme

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO5323441 + bevacizumab [Avastin]
bevacizumab [Avastin]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Dose-Finding Part: Dose limiting toxicity
Efficacy-Finding part: Progression-free survival

Secondary Outcome Measures

Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined
Dose-Finding part: Safety (incidence of adverse events)
Dose-Finding part: Efficacy (tumor response according to Response Assessment in Neurooncology (RANO) criteria
Dose-Finding part: Glioblastoma biomarker
Efficacy-Finding part: Overall Response Rate
Efficacy-Finding part: Disease Control Rate
Efficacy-Finding part: Duration of Response
Efficacy-Finding part: Progression-free survival
Efficacy-Finding part: Overall Survival
Efficacy-Finding part: Safety (incidence of adverse events)
Efficacy-Finding part: Glioblastoma biomarker
Efficacy-Finding part: Pharmacokinetics (serum levels) of RO5323441 and Avastin when combined

Full Information

First Posted
March 2, 2011
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01308684
Brief Title
A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent Glioblastoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RO5323441 + bevacizumab [Avastin]
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
Efficacy-Finding part: 10 mg/kg intravenously once every two weeks
Primary Outcome Measure Information:
Title
Dose-Finding Part: Dose limiting toxicity
Time Frame
Day 28
Title
Efficacy-Finding part: Progression-free survival
Time Frame
From baseline to disease progression or death (>12 months)
Secondary Outcome Measure Information:
Title
Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined
Time Frame
From baseline to disease progression or death (>12 months)
Title
Dose-Finding part: Safety (incidence of adverse events)
Time Frame
From baseline to disease progression or death (>12 months)
Title
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)
Title
Dose-Finding part: Glioblastoma biomarker
Time Frame
From baseline to disease progression or death (>12 months)
Title
Efficacy-Finding part: Overall Response Rate
Time Frame
From baseline to disease progression or death (>12 months)
Title
Efficacy-Finding part: Disease Control Rate
Time Frame
From baseline to disease progression or death (>12 months)
Title
Efficacy-Finding part: Duration of Response
Time Frame
From baseline to disease progression or death (>12 months)
Title
Efficacy-Finding part: Progression-free survival
Time Frame
From baseline to disease progression or death (>12 months)
Title
Efficacy-Finding part: Overall Survival
Time Frame
From baseline to disease progression or death (>12 months)
Title
Efficacy-Finding part: Safety (incidence of adverse events)
Time Frame
From baseline to disease progression or death (>12 months)
Title
Efficacy-Finding part: Glioblastoma biomarker
Time Frame
From baseline to disease progression or death (>12 months)
Title
Efficacy-Finding part: Pharmacokinetics (serum levels) of RO5323441 and Avastin when combined
Time Frame
From baseline to disease progression or death (>12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
City
Marseille
ZIP/Postal Code
13385
Country
France
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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