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To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Open label single arm trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00299804 | Drug | Dosage form: 5 mg and 20 mg tablet Dosage: 15 mg, 30 mg and 45 mg, orally, once daily Number of Cycles: until progression or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities | End of study |
| Measure | Description | Time Frame |
|---|---|---|
| To explore PD markers | End of study | |
| To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing | End of study | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Sunto-gun | Shizuoka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22249430 | Derived | Takahashi T, Boku N, Murakami H, Naito T, Tsuya A, Nakamura Y, Ono A, Machida N, Yamazaki K, Watanabe J, Ruiz-Garcia A, Imai K, Ohki E, Yamamoto N. Phase I and pharmacokinetic study of dacomitinib (PF-00299804), an oral irreversible, small molecule inhibitor of human epidermal growth factor receptor-1, -2, and -4 tyrosine kinases, in Japanese patients with advanced solid tumors. Invest New Drugs. 2012 Dec;30(6):2352-63. doi: 10.1007/s10637-011-9789-z. Epub 2012 Jan 17. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C525726 | dacomitinib |
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| To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST |
| End of study |