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This is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is to evaluate the rate of clinical benefit response to quarfloxin treatment including the reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable hormones or other biochemical tumor markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quarfloxin | Experimental | Single arm study - open label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quarfloxin | Drug | IV Quarfloxin 240 mg/m2 daily x5 days every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit. Clinical benefit is defined as a reduction of secretory symptoms or reduction of quantifiable hormones or other biochemical tumor markers where concomitantly there is an absence of radiological evidence for tumor progression. | monthly for clinical benefit, every two months for tumor progression |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Hematology and Oncology | Birmingham | Alabama | United States | |||
| Rocky Mountain Cancer Centers |
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| Denver |
| Colorado |
| 80218 |
| United States |
| Front Range Cancer Specialists | Fort Collins | Colorado | United States |
| Ocala | Florida | 34471 | United States |
| Southern New Mexico Cancer Center | Las Cruces | New Mexico | United States |
| Texas Oncology | Amarillo | Texas | United States |
| Texas Oncology | Dallas | Texas | 75246 | United States |
| El Paso Cancer Treatment Center | El Paso | Texas | United States |
| Cancer Care Centers of South Texas | Kerrville | Texas | United States |
| UT Health Science Center | San Antonio | Texas | 78229 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Northwest Cancer Specialists | Vancouver | Washington | 98684 | United States |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D002276 | Carcinoid Tumor |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| C545184 | CX 3543 |
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