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This study is being conducted to determine the safety and biologic activity of PX-478, and to allow for observation of any preliminary evidence of antitumor activity in patients with advanced metastatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Drug | Experimental | Dose Escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PX-478 | Drug | Oral formulation, dose escalation, taken on days 1 to 5 of a 21 day cycle until progression or development of unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the MTD of PX-478 administered orally on days one to five of a 21 day cycle | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety profile of PX-478 when administered orally on days one to five of a 21 day cycle | 42 days | |
| To evaluate pharmacodynamic measures of the effects of PX 478 on the HIF 1-alpha pathway, and related tumor markers | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18729192 | Derived | Palayoor ST, Mitchell JB, Cerna D, Degraff W, John-Aryankalayil M, Coleman CN. PX-478, an inhibitor of hypoxia-inducible factor-1alpha, enhances radiosensitivity of prostate carcinoma cells. Int J Cancer. 2008 Nov 15;123(10):2430-7. doi: 10.1002/ijc.23807. |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C492908 | 2-amino-3-(4'-N,N-bis(2-chloroethyl)amino)phenylpropionic acid N-oxide |
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| To determine the PK profile of PX 478 when administered orally on days one to five of a 21 day cycle | 21 days |
| To evaluate the effects of PX 478 on tumor blood flow and vascular permeability as measured by DCE MRI | 21 days |
| To evaluate the anti-tumor activity of PX 478 in patients with advanced malignancies | 42 days |
| The University of Texas M.D. Anderson Cancer Center |
| Houston |
| Texas |
| 77030 |
| United States |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |