Clinical trial · Interventional
A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent Glioblastoma
Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab [Avastin] | Drug | Bevacizumab | ALIAS |
| RO5323441 + bevacizumab [Avastin] | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: RO5323441 + bevacizumab [Avastin]
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: bevacizumab [Avastin]
Primary outcomes (2)
- measure
- Dose-Finding Part: Dose limiting toxicity
- timeFrame
- Day 28
- measure
- Efficacy-Finding part: Progression-free survival
- timeFrame
- From baseline to disease progression or death (>12 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available