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This is a Phase I study which will analyze any food-drug effects as well as QTc effects of perifosine. Safety and efficacy will also be evaluated.
Patients who complete the first 24 days on single agent perifosine may have the opportunity to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine + perifosine; or 3) switch to the combination of sorafenib + perifosine.
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perifosine 100 mg | Experimental | Perifosine 100 mg orally daily under Fed and Fasted conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perifosine | Drug | 100 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects of food on the PK profile and bioavailability of perifosine, and to evaluate the effects of perifosine treatment on ECG parameters |
| 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies |
|
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ed Cullen, PhD | Keryx / AOI Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas | Texas | 75230 | United States | |||
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C105905 | perifosine |
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| Up to 6 months |
| Houston |
| Texas |
| 77030 |
| United States |