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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03216499 | HIF-2 Alpha Inhibitor PT2385 in Treating Patients With Recurrent Glioblastoma | PHASE2 | COMPLETED | 24 | — | — | Sep 14, 2017 | Jun 5, 2020 | May 9, 2022 | 10 | United States |
Tumor radiographic response assessed by Response Assessment in Neuro-Oncology (RANO) criteria. * Complete Response (CR) = no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status * Partial Response (PR) = ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status * Stable Disease (SD) = \<50% reduction to \<25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status * Progressive Disease (PD) = ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.
| Arm | Type | Description |
|---|---|---|
| Treatment (HIF-2 alpha inhibitor PT2385) | EXPERIMENTAL | Patients receive HIF-2 alpha inhibitor PT2385 PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pharmacological Study Laboratory Biomarker Analysis Pharmacogenomic Study |
| Name | Type | Description |
|---|---|---|
| HIF-2alpha Inhibitor PT2385 | DRUG | Given PO |
| Pharmacological Study | OTHER | Correlative studies |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Pharmacogenomic Study | OTHER | Correlative studies |
Inclusion Criteria: * • Patients must have histologically confirmed glioblastoma that is progressive or recurrent following radiation therapy and temozolomide according to the Response Assessment in Neuro-Oncology (RANO) criteria with: * New contrast-enhancing lesion outside of radiation field o...