Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02014844 | Phase 2 Study to Investigate the Efficacy and Safety of Aldoxorubicin in Subjects With Glioblastoma | PHASE2 | COMPLETED | 28 | — | — | Mar 1, 2014 | Dec 1, 2016 | May 29, 2024 | 4 | United States |
ORR was defined as the proportion of patients with objective CR or PR by RANO working group criteria. CR: required all the following: complete disappearance of all enhancing measurable/ non-measurable disease sustained for at least 4 weeks; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions; patients must be off corticosteroids (or on physiologic replacement doses only); and stable or improved clinically. Patients with non-measurable disease only cannot have a CR. PR: Requires all of the following: ≥50% decrease compared with baseline sustained for at least 4 weeks; no PD of non-measurable disease; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at the time of the baseline scan; and stable or improved clinically. Patients with non-measurable disease only can't have a PR.
| Arm | Type | Description |
|---|---|---|
| 250 mg/m2 aldoxorubicin | EXPERIMENTAL | Subjects received 250 mg/m2 aldoxorubicin IV. |
| 350 mg/m2 aldoxorubicin | EXPERIMENTAL | Subjects received 350 mg/m2 aldoxorubicin IV. |
| Name | Type | Description |
|---|---|---|
| 250 mg/m2 aldoxorubicin | DRUG | - |
| 350 mg/m2 aldoxorubicin | DRUG | - |
Inclusion Criteria: 1. Age 18 years or older; male or female 2. Histologically or cytologically confirmed unresectable GBM. Subjects with recurrent disease whose prior pathology demonstrated GBM will not need to be re-biopsied. Subjects with prior low-grade glioma or anaplastic glioma are eligible ...