Clinical trial · Interventional
A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma
Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of 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 randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.
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 |
| fotemustine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Calibration Arm
- interventionNames
- Drug: fotemustine
- type
- EXPERIMENTAL
- label
- Investigational Arm
- interventionNames
- Drug: bevacizumab [Avastin]
Primary outcomes (2)
- measure
- Percentage of Participants Alive 6 Months After Start of Treatment
- timeFrame
- 6 months
- description
- Overall survival (OS) was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of magnetic resonance imaging (MRI) assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/=18 years of age * Diagnosis of recurrent glioblastoma multiforme (Grade IV) * Previous treatment with temozolomide and radiotherapy * First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy) * Adequate hematological, biochemical and organ functions Exclusion Criteria: * Previous treatment with Avastin or other anti-angiogenic drugs * Residual relevant toxicity resulting from previous therapy * Radiotherapy within the 3 months prior to the diagnosis of disease progression * Chemotherapy in the previous 4 weeks * Other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma) * Clinically significant cardiovascular diseases
References
Publications (1)
- DERIVEDBrandes AA, Finocchiaro G, Zagonel V, Reni M, Caserta C, Fabi A, Clavarezza M, Maiello E, Eoli M, Lombardi G, Monteforte M, Proietti E, Agati R, Eusebi V, Franceschi E. AVAREG: a phase II, randomized, noncomparative study of fotemustine or bevacizumab for patients with recurrent glioblastoma. Neuro Oncol. 2016 Sep;18(9):1304-12. doi: 10.1093/neuonc/now035. Epub 2016 Mar 6. PMID 26951379