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

November 1, 2016 updated by: Hoffmann-La Roche

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy-Finding part: Progression-free survival
Time Frame: From baseline to disease progression or death (>12 months)
From baseline to disease progression or death (>12 months)
Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined
Time Frame: From baseline to disease progression or death (>12 months)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
From baseline to disease progression or death (>12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

March 2, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP25389
  • 2010-021795-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma Multiforme

Clinical Trials on RO5323441 + bevacizumab [Avastin]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe