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

NCT ID: NCT01308684

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RO5323441 + bevacizumab [Avastin]

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

Efficacy-Finding part: 10 mg/kg intravenously once every two weeks

Interventions

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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

Intervention Type DRUG

bevacizumab [Avastin]

Efficacy-Finding part: 10 mg/kg intravenously once every two weeks

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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København Ø, , Denmark

Site Status

Marseille, , France

Site Status

Zurich, , Switzerland

Site Status

Manchester, , United Kingdom

Site Status

Countries

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Denmark France Switzerland United Kingdom

Other Identifiers

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2010-021795-29

Identifier Type: -

Identifier Source: secondary_id

BP25389

Identifier Type: -

Identifier Source: org_study_id