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This is an open label dose escalation study to find the maximum tolerated dose (MTD) of PKI-179 in subjects with solid tumors. Part 1 of the study will be the dose estimation phase and will be open to subjects with all solid tumors. Part 2 will be the dose confirmation phase and will be open to subjects with breast, non small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma. All subjects will receive daily oral dosing of PKI-179. A continuous reassessment method (CRM) design will be used, which will take into account dose limiting toxicity (DLT) information from each dose level explored in order to determine the next dose level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | PKI-179 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PKI-179 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by physical examinations, electrocardiograms, laboratory assessments, vital signs, adverse events and serious adverse events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor assessments, blood samples to look at how the drug enters your body and what the body does with it. | 2 years |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
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| ID | Term |
|---|---|
| C549124 | 1-(4-(4-(3-oxa-8-azabicyclo(3.2.1)octan-8-yl)-6-morpholino-1,3,5-triazin-2-yl)phenyl)-3-(pyridin-4-yl)urea |
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