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NCT Number: NCT01308684

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

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Key information

Conditions

Glioblastoma Multiforme Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

København Ø, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

bevacizumab [Avastin]

Drug

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

Primary outcomes

  1. Dose-Finding Part: Dose limiting toxicity

    Time frame: Day 28

  2. Efficacy-Finding part: Progression-free survival

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

Secondary outcomes

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

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

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

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

  3. 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)

  4. Dose-Finding part: Glioblastoma biomarker

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

  5. Efficacy-Finding part: Overall Response Rate

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

  6. Efficacy-Finding part: Disease Control Rate

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

  7. Efficacy-Finding part: Duration of Response

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

  8. Efficacy-Finding part: Progression-free survival

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

  9. Efficacy-Finding part: Overall Survival

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

  10. Efficacy-Finding part: Safety (incidence of adverse events)

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

  11. Efficacy-Finding part: Glioblastoma biomarker

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

  12. Efficacy-Finding part: Pharmacokinetics (serum levels) of RO5323441 and Avastin when combined

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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