A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (B
This will be a prospective, randomized, standard of care (SoC) controlled, parallel, open-label, multicenter pivotal study to investigate the efficacy and safety of Bevacizumab (BEV) in combination with or without microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice f
| Condition(s) | Glioblastoma Multiforme, Glioblastoma, Glioblastoma Multiforme, Adult, Glioma, Brain Tumor, Brain Tumor, Recurrent, Neoplasms, Neoplasms, Nerve Tissue |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This will be a prospective, randomized, standard of care (SoC) controlled, parallel, open-label, multicenter pivotal study to investigate the efficacy and safety of Bevacizumab (BEV) in combination with or without microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide. |
| Who can participate | Inclusion Criteria: 1. Male or female patients ≥ 18 years of age at the time of study enrollment. 2. Body mass index (BMI) ≥ 17 kg/m2. 3. Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging (CE-MRI), following prior radiotherapy and temozolomide chemotherapy. 4. Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study enrollment. 5. Patients must have radiographic evidence of either at least an 80% resection of enhancing tumor following recurrence or a maximal measurable residual tumor ≤ 20 cm3. 6. If patients are receiving corticosteroids, they must have been on a stable or decreasing dose of corticosteroids |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | NaviFUS Corporation |
| Locations | Taipei, Taiwan; Taoyuan, Taiwan |
| Start date | 2024-11-08 |
| NCT ID | NCT06496971 |
| Official listing | https://clinicaltrials.gov/study/NCT06496971 |