NCT01308684

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2011

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

March 2, 2011

Last Update Submit

November 1, 2016

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (2)

  • Dose-Finding Part: Dose limiting toxicity

    Day 28

  • Efficacy-Finding part: Progression-free survival

    From baseline to disease progression or death (>12 months)

Secondary Outcomes (12)

  • Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined

    From baseline to disease progression or death (>12 months)

  • Dose-Finding part: Safety (incidence of adverse events)

    From baseline to disease progression or death (>12 months)

  • Dose-Finding part: Efficacy (tumor response according to Response Assessment in Neurooncology (RANO) criteria

    From baseline to disease progression or death (>12 months)

  • Dose-Finding part: Glioblastoma biomarker

    From baseline to disease progression or death (>12 months)

  • Efficacy-Finding part: Overall Response Rate

    From baseline to disease progression or death (>12 months)

  • +7 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: RO5323441 + bevacizumab [Avastin]

2

EXPERIMENTAL
Drug: bevacizumab [Avastin]

Interventions

RO5323441 + bevacizumab [Avastin]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

1
bevacizumab [Avastin]DRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

København Ø, 2100, Denmark

Location

Unknown Facility

Marseille, 13385, France

Location

Unknown Facility

Zurich, 8091, Switzerland

Location

Unknown Facility

Manchester, M2O 4BX, United Kingdom

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

TB-403Bevacizumab

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 4, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FR(1)GB(1)DK(1)CH(1)