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Phase 1b of the study, will evaluate the safety and tolerability of AQ4N treatment at three different dose levels.
Phase 2a of the study, will further evaluate the safety, tolerability, and in addition efficacy of AQ4N treatment at a tolerated dose selected from Phase 1b.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQ4N | Drug | |||
| Temozolomide | Drug | |||
| Radiotherapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Evaluation of the safety and tolerability of AQ4N in combination with radiation therapy and temozolomide (TEMODAR®)for the treatment of glioblastoma multiforme (GBM). Dose levels for the Phase 2a will be selected. | ||
| Phase 2a: Rate of progression-free survival at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2a: Rate of progression-free survival at 12 months | ||
| Percent of subjects alive at 12 months | ||
| Duration of progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Recruiting | Los Angeles | California | United States |
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| Time to progression |
| Duration of overall survival |
| Northwestern University Feinberg School of Medicine | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Henry Ford Health Systems | Recruiting | Detroit | Michigan | 48202 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Baylor Research Institute | Recruiting | Dallas | Texas | United States |
|
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C094428 | AQ4N |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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